[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2020 Edition]
[From the U.S. Government Publishing Office]
[[Page i]]
Title 21
Food and Drugs
________________________
Parts 800 to 1299
Revised as of April 1, 2020
Containing a codification of documents of general
applicability and future effect
As of April 1, 2020
Published by the Office of the Federal Register
National Archives and Records Administration as a
Special Edition of the Federal Register
[[Page ii]]
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[[Page iii]]
Table of Contents
Page
Explanation................................................. v
Title 21:
Chapter I--Food and Drug Administration, Department
of Health and Human Services (Continued) 3
Finding Aids:
Table of CFR Titles and Chapters........................ 959
Alphabetical List of Agencies Appearing in the CFR...... 979
List of CFR Sections Affected........................... 989
[[Page iv]]
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Cite this Code: CFR
To cite the regulations in
this volume use title,
part and section number.
Thus, 21 CFR 800.10 refers
to title 21, part 800,
section 10.
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[[Page v]]
EXPLANATION
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1
The appropriate revision date is printed on the cover of each
volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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To determine whether a Code volume has been amended since its
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EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
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OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires
Federal agencies to display an OMB control number with their information
collection request.
[[Page vi]]
Many agencies have begun publishing numerous OMB control numbers as
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PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of
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for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.
``[RESERVED]'' TERMINOLOGY
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INCORPORATION BY REFERENCE
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This material, like any other properly issued regulation, has the force
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What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on which
approval is based are:
(a) The incorporation will substantially reduce the volume of
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(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If
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CFR INDEXES AND TABULAR GUIDES
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that volume.
[[Page vii]]
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the revision dates of the 50 CFR titles.
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INQUIRIES
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Oliver A. Potts,
Director,
Office of the Federal Register
April 1, 2020
[[Page ix]]
THIS TITLE
Title 21--Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300 to end.
The first eight volumes, containing parts 1-1299, comprise Chapter I--
Food and Drug Administration, Department of Health and Human Services.
The ninth volume, containing part 1300 to end, includes Chapter II--Drug
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes
represent all current regulations codified under this title of the CFR
as of April 1, 2020.
For this volume, Robert J. Sheehan, III was Chief Editor. The Code
of Federal Regulations publication program is under the direction of
John Hyrum Martinez, assisted by Stephen J. Frattini.
[[Page 1]]
TITLE 21--FOOD AND DRUGS
(This book contains Parts 800 to 1299)
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Part
chapter i--Food and Drug Administration, Department of
Health and Human Services (Continued)..................... 800
[[Page 3]]
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
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Editorial Note: Nomenclature changes to chapter I appear at 59 FR
14366, Mar. 28, 1994; 68 FR 24879, May 9, 2003; and 69 FR 13717, Mar.
24, 2004.
SUBCHAPTER H--MEDICAL DEVICES
Part Page
800 General..................................... 7
801 Labeling.................................... 18
803 Medical device reporting.................... 50
806 Medical devices; reports of corrections and
removals................................ 67
807 Establishment registration and device
listing for manufacturers and initial
importers of devices.................... 71
808 Exemptions from Federal preemption of State
and local medical device requirements... 89
809 In vitro diagnostic products for human use.. 98
810 Medical device recall authority............. 107
812 Investigational device exemptions........... 115
813
[Reserved]
814 Premarket approval of medical devices....... 136
820 Quality system regulation................... 160
821 Medical device tracking requirements........ 174
822 Postmarket surveillance..................... 180
830 Unique device identification................ 188
860 Medical device classification procedures.... 197
861 Procedures for performance standards
development............................. 210
862 Clinical chemistry and clinical toxicology
devices................................. 214
864 Hematology and pathology devices............ 262
866 Immunology and microbiology devices......... 292
868 Anesthesiology devices...................... 387
870 Cardiovascular devices...................... 411
872 Dental devices.............................. 445
874 Ear, nose, and throat devices............... 475
876 Gastroenterology-urology devices............ 491
878 General and plastic surgery devices......... 523
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880 General hospital and personal use devices... 549
882 Neurological devices........................ 575
884 Obstetrical and gynecological devices....... 605
886 Ophthalmic devices.......................... 635
888 Orthopedic devices.......................... 664
890 Physical medicine devices................... 692
892 Radiology devices........................... 717
895 Banned devices.............................. 735
898 Performance standard for electrode lead
wires and patient cables................ 741
SUBCHAPTER I--MAMMOGRAPHY QUALITY STANDARDS ACT
900 Mammography................................. 743
SUBCHAPTER J--RADIOLOGICAL HEALTH
1000 General..................................... 778
1002 Records and reports......................... 787
1003 Notification of defects or failure to comply 795
1004 Repurchase, repairs, or replacement of
electronic products..................... 799
1005 Importation of electronic products.......... 801
1010 Performance standards for electronic
products: General....................... 805
1020 Performance standards for ionizing radiation
emitting products....................... 810
1030 Performance standards for microwave and
radio frequency emitting products....... 842
1040 Performance standards for light-emitting
products................................ 845
1050 Performance standards for sonic, infrasonic,
and ultrasonic radiation-emitting
products................................ 869
SUBCHAPTER K--TOBACCO PRODUCTS
1100 Tobacco products subject to FDA authority... 873
1105 General..................................... 874
1107 Establishment registration, product listing,
and substantial equivalence reports..... 874
1140 Cigarettes, smokeless tobacco, and covered
tobacco products........................ 876
1141 Cigarette package and advertising warnings
(Eff. until 6-18-21).................... 881
1141 Required warnings for cigarette packages and
advertisements (Eff. 6-18-21)........... 885
1143 Minimum required warning statements......... 888
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1150 User fees................................... 893
SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE
FOOD AND DRUG ADMINISTRATION
1210 Regulations under the Federal Import Milk
Act..................................... 897
1230 Regulations under the Federal Caustic Poison
Act..................................... 900
1240 Control of communicable diseases............ 907
1250 Interstate conveyance sanitation............ 912
1251-1269
[Reserved]
1270 Human tissue intended for transplantation... 923
1271 Human cells, tissues, and cellular and
tissue-based products................... 928
1272-1299
[Reserved]
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SUBCHAPTER H_MEDICAL DEVICES
PART 800_GENERAL--Table of Contents
Subpart A [Reserved]
Subpart B_Requirements for Specific Medical Devices
Sec.
800.10 Contact lens solutions; sterility.
800.12 Contact lens solutions and tablets; tamper-resistant packaging.
800.20 Patient examination gloves and surgeons' gloves; sample plans and
test method for leakage defects; adulteration.
Subpart C_Administrative Practices and Procedures
800.55 Administrative detention.
800.75 Requests for supervisory review of certain decisions made by the
Center for Devices and Radiological Health.
Authority: 5 U.S.C. 551-559; 21 U.S.C. 301-399f.
Subpart A [Reserved]
Subpart B_Requirements for Specific Medical Devices
Sec. 800.10 Contact lens solutions; sterility.
(a)(1) Informed medical opinion is in agreement that all
preparations offered or intended for ophthalmic use, including contact
lens solutions, should be sterile. It is further evident that such
preparations purport to be of such purity and quality as to be suitable
for safe use in the eye.
(2) The Food and Drug Administration concludes that all such
preparations, if they are not sterile, fall below their professed
standard of purity or quality and may be unsafe. In a statement of
policy issued on September 1, 1964, the Food and Drug Administration
ruled that liquid preparations offered or intended for ophthalmic use
that are not sterile may be regarded as adulterated within the meaning
of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act),
and, further, may be deemed misbranded within the meaning of section
502(j) of the act. By this regulation, this ruling is applicable to all
preparations for ophthalmic use that are regulated as medical devices,
i.e., contact lens solutions. By the regulation in Sec. 200.50 of this
chapter, this ruling is applicable to ophthalmic preparations that are
regulated as drugs.
(3) The containers shall be sterile at the time of filling and
closing, and the container or individual carton shall be so sealed that
the contents cannot be used without destroying the seal. The packaging
and labeling of these solutions shall also comply with Sec. 800.12 on
tamper-resistant packaging requirements.
(b) Liquid ophthalmic preparations packed in multiple-dose
containers should:
(1) Contain one or more suitable and harmless substances that will
inhibit the growth of microorganisms; or
(2) Be so packaged as to volume and type of container and so labeled
as to duration of use and with such necessary warnings as to afford
adequate protection and minimize the hazard of injury resulting from
contamination during use.
(c) Eye cups, eye droppers, and other dispensers intended for
ophthalmic use should be sterile, and may be regarded as falling below
their professed standard of purity or quality if they are not sterile.
These articles, which are regulated as medical devices unless packaged
with the drugs with which they are to be used, should be packaged so as
to maintain sterility until the package is opened and be labeled, on or
within the retail package, so as to afford adequate directions and
necessary warnings to minimize the hazard of injury resulting from
contamination during use.
[47 FR 50455, Nov. 5, 1982]
Sec. 800.12 Contact lens solutions and tablets; tamper-resistant packaging.
(a) General. Unless contact lens solutions used, for example, to
clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses
and salt tablets or other dosage forms to be used to make any such
solutions are packaged in tamper-resistant retail packages, there
[[Page 8]]
is the opportunity for the malicious adulteration of these products with
risks both to individuals who unknowingly purchase adulterated products
and with loss of consumer confidence in the security of the packages of
over-the-counter (OTC) health care products. The Food and Drug
Administration has the authority and responsibility under the Federal
Food, Drug, and Cosmetic Act (the act) to establish a uniform national
standard for tamper-resistant packaging of those OTC products vulnerable
to malicious adulteration that will improve the security of OTC
packaging and help assure the safety and effectiveness of the products
contained therein. A contact lens solution or tablet or other dosage
form to be used to make such a solution for retail sale that is not
packaged in a tamper-resistant package and labeled in accordance with
this section is adulterated under section 501 of the act or misbranded
under section 502 of the act, or both.
(b) Requirement for tamper-resistant package. Each manufacturer and
packer who packages for retail sale a product regulated as a medical
device that is a solution intended for use with contact lenses, e.g.,
for cleaning, disinfecting, wetting, lubricating, rinsing, soaking, or
storing contact lenses or tablets or other dosage forms to be used to
make any such solution shall package the product in a tamper-resistant
package, if this product is accessible to the public while held for
sale. A tamper-resistant package is one having an indicator or barrier
to entry which, if breached or missing, can reasonably be expected to
provide visible evidence to consumers that tampering has occurred. To
reduce the likelihood of substitution of a tamper-resistant feature
after tampering, the indicator or barrier to entry is required to be
distinctive by design or by the use of an identifying characteristic
(e.g., a pattern, name, registered trademark, logo, or picture). For
purposes of this section, the term ``distinctive by design'' means the
package cannot be duplicated with commonly available material or through
commonly available processes. A tamper-resistant package may involve an
immediate-container and closure system or secondary-container or carton
system or any combination of systems intended to provide a visual
indication of package integrity. The tamper-resistant feature shall be
designed to and shall remain intact when handled in a reasonable manner
during manufacture, distribution, and retail display.
(c) Labeling. Each retail package of a product covered by this
section is required to bear a statement that is prominently placed so
that consumers are alerted to the tamper-resistant feature of the
package. The labeling statement is also required to be so placed that it
will be unaffected if the tamper-resistant feature of the package is
breached or missing. If the tamper-resistant feature chosen to meet the
requirement in paragraph (b) of this section is one that uses an
identifying characteristic, that characteristic is required to be
referred to in the labeling statement. For example, the labeling
statement on a bottle with a shrink band could say ``For your
protection, this bottle has an imprinted seal around the neck.''
(d) Requests for exemptions from packaging and labeling
requirements. A manufacturer or packer may request an exemption from the
packaging and labeling requirements of this section. A request for an
exemption is required to be submitted in the form of a citizen petition
under Sec. 10.30 of this chapter and should be clearly identified on
the envelope as a ``Request for Exemption from Tamper-resistant Rule.''
A petition for an exemption from a requirement of this section is
required to contain the same kind of information about the product as is
specified for OTC drugs in Sec. 211.132(d) of this chapter.
(e) Products subject to approved premarket approval applications.
Holders of approved premarket approval applications for products subject
to this section are required to submit supplements to provide for
changes in packaging to comply with the requirement of paragraph (b) of
this section unless these changes do not affect the composition of the
container, the torque (tightness) of the container, or the composition
of the closure component in contact with the contents (cap liner
[[Page 9]]
or innerseal) as these features are described in the approved premarket
approval application. Any supplemental premarket approval application
under this paragraph is required to include data sufficient to show that
these changes do not adversely affect the product.
(f) Effective date. Each product subject to this section is required
to comply with the requirements of this section on the dates listed
below except to the extent that a product's manufacturer or packer has
obtained an exemption from a packaging or labeling requirement:
(1) Initial effective date for packaging requirements. (i) The
packaging requirement in paragraph (b) of this section is effective on
February 7, 1983 for each contact lens solution packaged for retail sale
on or after that date, except for the requirement in paragraph (b) of
this section for a distinctive indicator or barrier to entry.
(ii) The packaging requirement in paragraph (b) of this section is
effective on May 5, 1983 for each tablet that is to be used to make a
contact lens solution and that is packaged for retail sale on or after
that date.
(2) Initial effective date for labeling requirements. The
requirement in paragraph (b) of this section that the indicator or
barrier to entry be distinctive by design and the requirement in
paragraph (c) of this section for a labeling statement are effective on
May 5, 1983 for each product subject to this section packaged for retail
sale on or after that date, except that the requirement for a specific
label reference to any identifying characteristic is effective on
February 6, 1984 for each affected product subject to this section
packaged for retail sale on or after that date.
(3) Retail level effective date. The tamper-resistant packaging
requirement of paragraph (b) of this section is effective on February 6,
1984 for each product subject to this section that is held for sale at
retail level on or after that date that was packaged for retail sale
before May 5, 1983. This does not include the requirement in paragraph
(b) of this section that the indicator or barrier to entry be
distinctive by design. Products packaged for retail sale after May 5,
1983, are required to be in compliance with all aspects of the
regulations without regard to the retail level effective date.
[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48
FR 16666, Apr. 19, 1983; 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr.
6, 1988; 73 FR 34859, June 19, 2008]
Effective Date Note: A document published at 48 FR 41579, Sept. 16,
1983, stayed the effective date of Sec. 800.12(f)(3) until further
notice.
Sec. 800.20 Patient examination gloves and surgeons' gloves; sample plans
and test method for leakage defects; adulteration.
(a) Purpose. The prevalence of human immunodeficiency virus (HIV),
which causes acquired immune deficiency syndrome (AIDS), and its risk of
transmission in the health care context, have caused the Food and Drug
Administration (FDA) to look more closely at the quality control of
barrier devices, such as surgeons' gloves and patient examination gloves
(collectively known as medical gloves) to reduce the risk of
transmission of HIV and other blood-borne infectious diseases. The
Centers for Disease Control (CDC) recommend that health care workers
wear medical gloves to reduce the risk of transmission of HIV and other
blood-borne infectious deseases. The CDC recommends that health care
workers wear medical gloves when touching blood or other body fluids,
mucous membranes, or nonintact skin of all patients; when handling items
or surfaces soiled with blood or other body fluids; and when performing
venipuncture and other vascular access procedures. Among other things,
CDC's recommendation that health care providers wear medical gloves
demonstrates the proposition that devices labeled as medical gloves
purport to be and are represented to be effective barriers against the
transmission of blood- and fluid-borne pathogens. Therefore, FDA,
through this regulation, is defining adulteration for patient
examination and surgeons' gloves as a means of assuring safe and
effective devices.
(1) For a description of a patient examination glove, see Sec.
880.6250. Finger cots, however, are excluded from the
[[Page 10]]
test method and sample plans in paragraphs (b) and (c) of this section.
(2) For a description of a surgeons' glove, see Sec. 878.4460 of
this chapter.
(b)(1) General test method. For the purposes of this part, FDA's
analysis of gloves for leaks and visual defects will be conducted by a
visual examination and by a water leak test method, using 1,000
milliliters (ml) of water.
(i) Units examined. Each medical glove will be analyzed
independently. When packaged as pairs, each glove is considered
separately, and both gloves will be analyzed.
(ii) Identification of defects. For this test, defects include leaks
detected when tested in accordance with paragraph (b)(3) of this
section. A leak is defined as the appearance of water on the outside of
the glove. This emergence of water from the glove constitutes a
watertight barrier failure. Other defects include tears, embedded
foreign objects, extrusions of glove material on the exterior or
interior surface of the glove, gloves that are fused together so that
individual glove separation is impossible, gloves that adhere to each
other and tear when separated, or other visual defects that are likely
to affect the barrier integrity.
(iii) Factors for counting defects. One defect in one glove is
counted as one defect. A defect in both gloves in a pair of gloves is
counted as two defects. If multiple defects, as defined in paragraph
(b)(1)(ii) of this section, are found in one glove, they are counted as
one defect. Visual defects and leaks that are observed in the top 40
millimeters (mm) of a glove will not be counted as a defect for the
purposes of this part.
(2) Leak test materials. FDA considers the following to be the
minimum materials required for this test :
(i) A 60 mm by 380 mm (clear) plastic cylinder with a hook on one
end and a mark scored 40 mm from the other end (a cylinder of another
size may be used if it accommodates both cuff diameter and any water
above the glove capacity);
(ii) Elastic strapping with velcro or other fastening material;
(iii) Automatic water-dispensing apparatus or manual device capable
of delivering 1,000 ml of water;
(iv) Stand with horizontal rod for hanging the hook end of the
plastic tube. The horizontal support rod must be capable of holding the
weight of the total number of gloves that will be suspended at any one
time, e.g., five gloves suspended will weigh about 5 kilograms (kg);
(v) Timer capable of measuring two minute intervals.
(3) Visual defects and leak test procedures. Examine the sample and
identify code/lot number, size, and brand as appropriate. Continue the
visual examination using the following procedures:
(i) Visual defects examination. Inspect the gloves for visual
defects by carefully removing the glove from the wrapper, box, or
package. Visually examine each glove for defects. As noted in paragraph
(b)(1)(iii) of this section, a visual defect observed in the top 40 mm
of a glove will not be counted as a defect for the purpose of this part.
Visually defective gloves do not require further testing, although they
must be included in the total number of defective gloves counted for the
sample.
(ii) Leak test set-up. (A) During this procedure, ensure that the
exterior of the glove remains dry. Attach the glove to the plastic fill
tube by bringing the cuff end to the 40 mm mark and fastening with
elastic strapping to make a watertight seal.
(B) Add 1,000 ml of room temperature water (i.e., 20 (deg)C to 30
(deg)C) into the open end of the fill tube. The water should pass freely
into the glove. (With some larger sizes of long-cuffed surgeons' gloves,
the water level may reach only the base of the thumb. With some smaller
gloves, the water level may extend several inches up the fill tube.)
(iii) Leak test examination. Immediately after adding the water,
examine the glove for water leaks. Do not squeeze the glove; use only
minimum manipulation to spread the fingers to check for leaks. Water
drops may be blotted to confirm leaking.
(A) If the glove does not leak immediately, keep the glove/filling
tube assembly upright and hang the assembly vertically from the
horizontal rod, using the wire hook on the open end of the fill tube (do
not support the filled glove while transferring).
[[Page 11]]
(B) Make a second observation for leaks 2 minutes after the water is
added to the glove. Use only minimum manipulation of the fingers to
check for leaks.
(C) Record the number of defective gloves.
(c) Sampling, inspection, acceptance, and adulteration. In
performing the test for leaks and other visual defects described in
paragraph (b) of this section, FDA will collect and inspect samples of
medical gloves, and determine when the gloves are acceptable as set out
in paragraphs (c)(1) through (c)(3) of this section.
(1) Sample plans. FDA will collect samples from lots of medical
gloves in accordance with agency sampling plans. These plans are based
on sample sizes, levels of sample inspection, and acceptable quality
levels (AQLs) found in the International Standard Organization's
standard ISO 2859, ``Sampling Procedures For Inspection By Attributes.''
(2) Sample sizes, inspection levels, and minimum AQLs. FDA will use
single normal sampling for lots of 1,200 gloves or less and multiple
normal sampling for all larger lots. FDA will use general inspection
level II in determining the sample size for any lot size. As shown in
the tables following paragraph (c)(3) of this section, FDA considers a
1.5 AQL to be the minimum level of quality acceptable for surgeons'
gloves and a 2.5 AQL to be the minimum level of quality acceptable for
patient examination gloves.
(3) Adulteration levels and accept/reject criteria. FDA considers a
lot of medical gloves to be adulterated when the number of defective
gloves found in the tested sample meets or exceeds the applicable
rejection number at the 1.5 AQL for surgeons' gloves or the 2.5 AQL for
patient examination gloves. These acceptance and rejection numbers are
identified in the tables following paragraph (c)(3) of this section as
follows:
Accept/Reject Criteria at 1.5 AQL for Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size Number Examined -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
8 to 90 Single sample ................. 8 0 1
----------------------------------------------------------------------------------------------------------------
91 to 280 Single sample ................. 32 1 2
----------------------------------------------------------------------------------------------------------------
281 to 500 Single sample ................. 50 2 3
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample ................. 80 3 4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 First 32 32 -- 4
Second 32 64 1 5
Third 32 96 2 6
Fourth 32 128 3 7
Fifth 32 160 5 8
Sixth 32 192 7 9
Seventh 32 224 9 10
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 First 50 50 0 4
Second 50 100 1 6
Third 50 150 3 8
Fourth 50 200 5 10
Fifth 50 250 7 11
Sixth 50 300 10 12
Seventh 50 350 13 14
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 First 80 80 0 5
Second 80 160 3 8
Third 80 240 6 10
Fourth 80 320 8 13
Fifth 80 400 11 15
Sixth 80 480 14 17
Seventh 80 560 18 19
----------------------------------------------------------------------------------------------------------------
35,000 First 125 125 1 7
Second 125 250 4 10
Third 125 375 8 13
Fourth 125 500 12 17
Fifth 125 625 17 20
[[Page 12]]
Sixth 125 750 21 23
Seventh 125 875 25 26
----------------------------------------------------------------------------------------------------------------
Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size Number Examined -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
5 to 50 Single sample ................. 5 0 1
----------------------------------------------------------------------------------------------------------------
51 to 150 Single sample ................. 20 1 2
----------------------------------------------------------------------------------------------------------------
151 to 280 Single sample ................. 32 2 3
----------------------------------------------------------------------------------------------------------------
281 to 500 Single sample ................. 50 3 4
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample ................. 80 5 6
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 First 32 32 0 4
Second 32 64 1 6
Third 32 96 3 8
Fourth 32 128 5 10
Fifth 32 160 7 11
Sixth 32 192 10 12
Seventh 32 224 13 14
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 First 50 50 0 5
Second 50 100 3 8
Third 50 150 6 10
Fourth 50 200 8 13
Fifth 50 250 11 15
Sixth 50 300 14 17
Seventh 50 350 18 19
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 First 80 80 1 7
Second 80 160 4 10
Third 80 240 8 13
Fourth 80 320 12 17
Fifth 80 400 17 20
Sixth 80 480 21 23
Seventh 80 560 25 26
----------------------------------------------------------------------------------------------------------------
35,000 and above First 125 125 2 9
Second 125 250 7 14
Third 125 375 13 19
Fourth 125 500 19 25
Fifth 125 625 25 29
Sixth 125 750 31 33
Seventh 125 875 37 38
----------------------------------------------------------------------------------------------------------------
(d) Compliance. Lots of gloves that are sampled, tested, and
rejected using procedures in paragraphs (b) and (c) of this section, are
considered adulterated within the meaning of section 501(c) of the act.
(1) Detention and seizure. Lots of gloves that are adulterated under
section 501(c) of the act are subject to administrative and judicial
action, such as detention of imported products and seizure of domestic
products.
(2) Reconditioning. FDA may authorize the owner of the product, or
the owner's representative, to attempt to recondition, i.e., bring into
compliance with the act, a lot or part of a lot of foreign gloves
detained at importation, or a lot or part of a lot of seized domestic
gloves.
(i) Modified sampling, inspection, and acceptance. If FDA authorizes
reconditioning of a lot or portion of a lot of adulterated gloves,
testing to confirm that the reconditioned gloves meet
[[Page 13]]
AQLs must be performed by an independent testing facility. The following
tightened sampling plan must be followed, as described in ISO 2859
``Sampling Procedures for Inspection by Attributes:''
(A) General inspection level II,
(B) Single sampling plans for tightened inspection,
(C) 1.5 AQL for surgeons' gloves, and
(D) 2.5 AQL for patient examination gloves.
(ii) Adulteration levels and acceptance criteria for reconditioned
gloves. (A) FDA considers a lot or part of a lot of adulterated gloves,
that is reconditioned in accordance with paragraph (d)(2)(i) of this
section, to be acceptable when the number of defective gloves found in
the tested sample does not exceed the acceptance number in the
appropriate tables in paragraph (d)(2)(ii)(B) of this section for
reconditioned surgeons' gloves or patient examination gloves.
(B) FDA considers a reconditioned lot of medical gloves to be
adulterated within the meaning of section 501(c) of the act when the
number of defective gloves found in the tested sample meets or exceeds
the applicable rejection number in the tables following paragraph
(d)(2)(ii)(B) of this section:
Accept/Reject Criteria at 1.5 AQL for Reconditioned Surgeons' Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
13 to 90 Single sample 13 0 1
----------------------------------------------------------------------------------------------------------------
91 to 500 Single sample 50 1 2
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample 80 2 3
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 Single sample 125 3 4
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 Single sample 200 5 6
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 Single sample 315 8 9
----------------------------------------------------------------------------------------------------------------
35,000 and above Single sample 500 12 13
----------------------------------------------------------------------------------------------------------------
Accept/Reject Criteria at 2.5 AQL for Reconditioned Patient Examination Gloves
----------------------------------------------------------------------------------------------------------------
Number Defective
Lot Size Sample Sample Size -------------------------------------
Accept Reject
----------------------------------------------------------------------------------------------------------------
8 to 50 Single sample 8 0 1
----------------------------------------------------------------------------------------------------------------
51 to 280 Single sample 32 1 2
----------------------------------------------------------------------------------------------------------------
281 to 500 Single sample 50 2 3
----------------------------------------------------------------------------------------------------------------
501 to 1,200 Single sample 80 3 4
----------------------------------------------------------------------------------------------------------------
1,201 to 3,200 Single sample 125 5 6
----------------------------------------------------------------------------------------------------------------
3,201 to 10,000 Single sample 200 8 9
----------------------------------------------------------------------------------------------------------------
10,001 to 35,000 Single sample 315 12 13
----------------------------------------------------------------------------------------------------------------
35,000 and above Single sample 500 18 19
----------------------------------------------------------------------------------------------------------------
[55 FR 51256, Dec. 12, 1990, as amended at 71 FR 75876, Dec. 19, 2006]
Subpart C_Administrative Practices and Procedures
Sec. 800.55 Administrative detention.
(a) General. This section sets forth the procedures for detention of
medical devices intended for human use believed to be adulterated or
misbranded.
[[Page 14]]
Administrative detention is intended to protect the public by preventing
distribution or use of devices encountered during inspections that may
be adulterated or misbranded, until the Food and Drug Administration
(FDA) has had time to consider what action it should take concerning the
devices, and to initiate legal action, if appropriate. Devices that FDA
orders detained may not be used, moved, altered, or tampered with in any
manner by any person during the detention period, except as authorized
under paragraph (h) of this section, until FDA terminates the detention
order under paragraph (j) of this section, or the detention period
expires, whichever occurs first.
(b) Criteria for ordering detention. Administrative detention of
devices may be ordered in accordance with this section when an
authorized FDA representative, during an inspection under section 704 of
the Federal Food, Drug, and Cosmetic Act (the act), has reason to
believe that a device, as defined in section 201(h) of the act, is
adulterated or misbranded.
(c) Detention period. The detention is to be for a reasonable period
that may not exceed 20 calendar days after the detention order is
issued, unless the FDA Division Director in whose division the devices
are located determines that a greater period is required to seize the
devices, to institute injunction proceedings, or to evaluate the need
for legal action, in which case the Division Director may authorize
detention for 10 additional calendar days. The additional 10-calendar-
day detention period may be ordered at the time the detention order is
issued or at any time thereafter. The entire detention period may not
exceed 30 calendar days, except when the detention period is extended
under paragraph (g)(6) of this section. An authorized FDA representative
may, in accordance with paragraph (j) of this section, terminate a
detention before the expiration of the detention period.
(d) Issuance of detention order. (1) The detention order shall be
issued in writing, in the form of a detention notice, signed by the
authorized FDA representative who has reason to believe that the devices
are adulterated or misbranded, and issued to the owner, operator, or
agent in charge of the place where the devices are located. If the owner
or the user of the devices is different from the owner, operator, or
agent in charge of the place where the devices are detained, a copy of
the detention order shall be provided to the owner or user of the
devices if the owner's or user's identity can be readily determined.
(2) If detention of devices in a vehicle or other carrier is
ordered, a copy of the detention order shall be provided to the shipper
of record and the owner of the vehicle or other carrier, if their
identities can be readily determined.
(3) The detention order shall include the following information:
(i) A statement that the devices identified in the order are
detained for the period shown;
(ii) A brief, general statement of the reasons for the detention;
(iii) The location of the devices;
(iv) A statement that these devices are not to be used, moved,
altered, or tampered with in any manner during that period, except as
permitted under paragraph (h) of this section, without the written
permission of an authorized FDA representative;
(v) Identification of the detained devices;
(vi) The detention order number;
(vii) The date and hour of the detention order;
(viii) The period of the detention;
(ix) The text of section 304(g) of the act and paragraph (g) (1) and
(2) of this section;
(x) A statement that any informal hearing on an appeal of a
detention order shall be conducted as a regulatory hearing under part 16
of this chapter, with certain exceptions described in paragraph (g)(3)
of this section; and
(xi) The mailing address, telephone number, and name of the FDA
Division Director.
(e) Approval of detention order. A detention order, before issuance,
shall be approved by the FDA Division Director in whose division the
devices are located. If prior written approval is not feasible, prior
oral approval shall be obtained and confirmed by written
[[Page 15]]
memorandum within FDA as soon as possible.
(f) Labeling or marking a detained device. An FDA representative
issuing a detention order under paragraph (d) of this section shall
label or mark the devices with official FDA tags that include the
following information:
(1) A statement that the devices are detained by the United States
Government in accordance with section 304(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 334(g)).
(2) A statement that the devices shall not be used, moved, altered,
or tampered with in any manner for the period shown, without the written
permission of an authorized FDA representative, except as authorized in
paragraph (h) of this section.
(3) A statement that the violation of a detention order or the
removal or alteration of the tag is punishable by fine or imprisonment
or both (section 303 of the act, 21 U.S.C. 333).
(4) The detention order number, the date and hour of the detention
order, the detention period, and the name of the FDA representative who
issued the detention order.
(g) Appeal of a detention order. (1) A person who would be entitled
to claim the devices, if seized, may appeal a detention order. Any
appeal shall be submitted in writing to the FDA Division Director in
whose division the devices are located within 5 working days of receipt
of a detention order. If the appeal includes a request for an informal
hearing, as defined in section 201(x) of the act, the appellant shall
request either that a hearing be held within 5 working days after the
appeal is filed or that the hearing be held at a later date, which shall
not be later than 20 calendar days after receipt of a detention order.
(2) The appellant of a detention order shall state the ownership or
proprietary interest the appellant has in the detained devices. If the
detained devices are located at a place other than an establishment
owned or operated by the appellant, the appellant shall include
documents showing that the appellant would have legitimate authority to
claim the devices if seized.
(3) Any informal hearing on an appeal of a detention order shall be
conducted as a regulatory hearing pursuant to regulation in accordance
with part 16 of this chapter, except that:
(i) The detention order under paragraph (d) of this section, rather
than the notice under Sec. 16.22(a) of this chapter, provides notice of
opportunity for a hearing under this section and is part of the
administrative record of the regulatory hearing under Sec. 16.80(a) of
this chapter.
(ii) A request for a hearing under this section should be addressed
to the FDA Division Director.
(iii) The last sentence of Sec. 16.24(e) of this chapter, stating
that a hearing may not be required to be held at a time less than 2
working days after receipt of the request for a hearing, does not apply
to a hearing under this section.
(iv) Paragraph (g)(4) of this section, rather than Sec. 16.42(a) of
this chapter, describes the FDA employees who preside at hearings under
this section.
(4) The presiding officer of a regulatory hearing on an appeal of a
detention order, who also shall decide the appeal, shall be an Office of
Regulatory Affairs Program Director or another FDA official senior to an
FDA Division Director who is permitted by Sec. 16.42(a) of this chapter
to preside over the hearing.
(5) If the appellant requests a regulatory hearing and requests that
the hearing be held within 5 working days after the appeal is filed, the
presiding officer shall, within 5 working days, hold the hearing and
render a decision affirming or revoking the detention.
(6) If the appellant requests a regulatory hearing and requests that
the hearing be held at a date later than within 5 working days after the
appeal is filed, but not later than 20 calendar days after receipt of a
detention order, the presiding officer shall hold the hearing at a date
agreed upon by FDA and the appellant. The presiding officer shall decide
whether to affirm or revoke the detention within 5 working days after
the conclusion of the hearing. The detention period extends to the date
of the decision even if the 5-working-day period for making the decision
extends beyond the otherwise applicable 20-calendar-day or 30-calendar-
day detention period.
[[Page 16]]
(7) If the appellant appeals the detention order but does not
request a regulatory hearing, the presiding officer shall render a
decision on the appeal affirming or revoking the detention within 5
working days after the filing of the appeal.
(8) If the presiding officer affirms a detention order, the devices
continue to be detained until FDA terminates the detention under
paragraph (j) of this section or the detention period expires, whichever
occurs first.
(9) If the presiding officer revokes a detention order, FDA shall
terminate the detention under paragraph (j) of this section.
(h) Movement of detained devices. (1) Except as provided in this
paragraph (h), no person shall move detained devices within or from the
place where they have been ordered detained until FDA terminates the
detention under paragraph (j) of this section or the detention period
expires, whichever occurs first.
(2) If detained devices are not in final form for shipment, the
manufacturer may move them within the establishment where they are
detained to complete the work needed to put them in final form. As soon
as the devices are moved for the purpose of the preceding sentence, the
individual responsible for their movement shall orally notify the FDA
representative who issued the detention order, or another responsible
division office official, of the movement of the devices. As soon as the
devices are put in final form, they shall be segregated from other
devices, and the individual responsible for their movement shall orally
notify the FDA representative who issued the detention order, or another
responsible division office official, of their new location. The devices
put in final form shall not be moved further without FDA approval.
(3) The FDA representative who issued the detention order, or
another responsible division office official, may approve, in writing,
the movement of detained devices for any of the following purposes:
(i) To prevent interference with an establishment's operations or
harm to the devices.
(ii) To destroy the devices.
(iii) To bring the devices into compliance.
(iv) For any other purpose that the FDA representative who issued
the detention order, or other responsible division office official,
believes is appropriate in the case.
(4) If an FDA representative approves the movement of detained
devices under paragraph (h)(3) of this section, the detained devices
shall remain segregated from other devices and the person responsible
for their movement shall immediately orally notify the official who
approved the movement of the devices, or another responsible FDA
division office official, of the new location of the detained devices.
(5) Unless otherwise permitted by the FDA representative who is
notified of, or who approves, the movement of devices under this
paragraph, the required tags shall accompany the devices during and
after movement and shall remain with the devices until FDA terminates
the detention or the detention period expires, whichever occurs first.
(i) Actions involving adulterated or misbranded devices. If FDA
determines that the detained devices, including any that have been put
in final form, are adulterated or misbranded, or both, it may initiate
legal action against the devices or the responsible individuals, or
both, or request that the devices be destroyed or otherwise brought into
compliance with the act under FDA's supervision.
(j) Detention termination. If FDA decides to terminate a detention
or when the detention period expires, whichever occurs first, an FDA
representative authorized to terminate a detention will issue a
detention termination notice releasing the devices to any person who
received the original detention order or that person's representative
and will remove, or authorize in writing the removal of, the required
labels or tags.
(k) Recordkeeping requirements. (1) After issuance of a detention
order under paragraph (d) of this section, the owner, operator, or agent
in charge of any factory, warehouse, other establishment, or consulting
laboratory where detained devices are manufactured, processed, packed,
or held shall
[[Page 17]]
have, or establish, and maintain adequate records relating to how the
detained devices may have become adulterated or misbranded, records on
any distribution of the devices before and after the detention period,
records on the correlation of any in-process detained devices that are
put in final form under paragraph (h) of this section to the completed
devices, records of any changes in, or processing of, the devices
permitted under the detention order, and records of any other movement
under paragraph (h) of this section. Records required under this
paragraph shall be provided to the FDA on request for review and
copying. Any FDA request for access to records required under this
paragraph shall be made at a reasonable time, shall state the reason or
purpose for the request, and shall identify to the fullest extent
practicable the information or type of information sought in the records
to which access is requested.
(2) Records required under this paragraph shall be maintained for a
maximum period of 2 years after the issuance of the detention order or
for such other shorter period as FDA directs. When FDA terminates the
detention or when the detention period expires, whichever occurs first,
FDA will advise all persons required under this paragraph to keep
records concerning that detention whether further recordkeeping is
required for the remainder of the 2-year, or shorter, period. FDA
ordinarily will not require further recordkeeping if the agency
determines that the devices are not adulterated or misbranded or that
recordkeeping is not necessary to protect the public health, unless the
records are required under other regulations in this chapter (e.g., the
good manufacturing practice regulation in part 820 of this chapter).
[44 FR 13239, Mar. 9, 1979, as amended at 49 FR 3174, Jan. 26, 1984; 69
FR 17292, Apr. 2, 2004; 79 FR 9412, Feb. 19, 2014; 82 FR 14147, Mar. 17,
2017; 85 FR 16555, Mar. 25, 2020]
Sec. 800.75 Requests for supervisory review of certain decisions made
by the Center for Devices and Radiological Health.
(a) Definitions. The following definitions shall apply to this
section:
(1) FDA means the Food and Drug Administration.
(2) 517A decision means a significant decision made by the Center
for Devices and Radiological Health, as set forth in section 517A of the
Federal Food, Drug, and Cosmetic Act, and includes one of the following
decisions:
(i) A substantially equivalent order under Sec. 807.100(a)(1) of
this chapter, or a not substantially equivalent order under Sec.
807.100(a)(2) of this chapter;
(ii) An approval order under Sec. 814.44(d) of this chapter, an
approvable letter under Sec. 814.44(e) of this chapter, a not
approvable letter under Sec. 814.44(f) of this chapter, or an order
denying approval under Sec. 814.45 of this chapter;
(iii) An approval order under Sec. 814.116(b) of this chapter, an
approvable letter under Sec. 814.116(c) of this chapter, a not
approvable letter under Sec. 814.116(d) of this chapter, or an order
denying approval under Sec. 814.118 of this chapter;
(iv) A grant or denial of a request for breakthrough device
designation under section 515B of the Federal Food, Drug, and Cosmetic
Act;
(v) An approval order under Sec. 812.30(a) of this chapter or a
disapproval order under Sec. 812.30(c) of this chapter;
(vi) A failure to reach agreement letter under section 520(g)(7) of
the Federal Food, Drug, and Cosmetic Act; or
(vii) A clinical hold determination under section 520(g)(8) of the
Federal Food, Drug, and Cosmetic Act.
(3) CDRH means the Center for Devices and Radiological Health.
(b) Submission of request--(1) Review of 517A decisions. (i) An
initial or sequential request for supervisory review within CDRH of a
517A decision under Sec. 10.75 of this chapter must be addressed to the
next organizational level or higher above the individual who made the
decision; submitted in electronic format in accordance with section
745A(b) of the Federal Food, Drug, and Cosmetic Act; marked ``Appeal:
Request for Supervisory Review''; and received by CDRH no later than 30
days after the date of the decision involved. Any such request for
supervisory review not received by CDRH within 30 days after the date of
the decision involved is not eligible for review. Except as provided in
paragraph (b)(1)(ii) or
[[Page 18]]
(iii) of this section, FDA will render a decision within 45 days of the
request for supervisory review.
(ii) A person requesting supervisory review under paragraph
(b)(1)(i) may request an in-person meeting or teleconference with the
supervisor reviewing the request for supervisory review. Except as
provided in paragraph (b)(1)(iii) of this section, if a request for in-
person meeting or teleconference is included in the request for
supervisory review to CDRH, CDRH will schedule the meeting or
teleconference to occur within 30 days of receipt of the request. Except
as provided in paragraph (b)(1)(iii) of this section, a decision will be
rendered within 30 days of such meeting or teleconference.
(iii) The timeframes for CDRH to render a decision provided in
(b)(1)(i) and (ii) of this section, and the timeframe to schedule an in-
person meeting or teleconference review in (b)(1)(ii) of this section,
do not apply if a matter related to the 517A decision under review is
referred by CDRH to external experts, such as an advisory committee, as
provided in Sec. 10.75(b) of this chapter.
(2) Supervisory review. An initial or sequential request for
supervisory review within CDRH under Sec. 10.75 of this chapter of a
decision other than a 517A decision that is not received by CDRH within
60 days after the date of the decision involved will be denied as
untimely, unless CDRH, for good cause, permits the request to be filed
after 60 days. An initial or sequential request for supervisory review
within CDRH of a decision other than a 517A decision must be addressed
to the next organizational level or higher above the individual who made
the decision; submitted in electronic format in accordance with section
745A(b) of the Federal Food, Drug, and Cosmetic Act, when applicable;
marked, ``Appeal: Request for Supervisory Review'' in the subject line
of the electronic request; and sent to the CDRH Ombudsman at
[email protected].
[84 FR 31477, July 2, 2019]
PART 801_LABELING--Table of Contents
Subpart A_General Labeling Provisions
Sec.
801.1 Medical devices; name and place of business of manufacturer,
packer or distributor.
801.3 Definitions.
801.4 Meaning of intended uses.
801.5 Medical devices; adequate directions for use.
801.6 Medical devices; misleading statements.
801.15 Medical devices; prominence of required label statements.
801.16 Medical devices; Spanish-language version of certain required
statements.
801.18 Format of dates provided on a medical device label.
Subpart B_Labeling Requirements for Unique Device Identification
801.20 Label to bear a unique device identifier.
801.30 General exceptions from the requirement for the label of a device
to bear a unique device identifier.
801.35 Voluntary labeling of a device with a unique device identifier.
801.40 Form of a unique device identifier.
801.45 Devices that must be directly marked with a unique device
identifier.
801.50 Labeling requirements for stand-alone software.
801.55 Request for an exception from or alternative to a unique device
identifier requirement.
801.57 Discontinuation of legacy FDA identification numbers assigned to
devices.
Subpart C_Labeling Requirements for Over-the-Counter Devices
801.60 Principal display panel.
801.61 Statement of identity.
801.62 Declaration of net quantity of contents.
801.63 Medical devices; warning statements for devices containing or
manufactured with chlorofluorocarbons and other class I ozone-
depleting substances.
Subpart D_Exemptions From Adequate Directions for Use
801.109 Prescription devices.
801.110 Retail exemption for prescription devices.
801.116 Medical devices having commonly known directions.
801.119 In vitro diagnostic products.
801.122 Medical devices for processing, repacking, or manufacturing.
801.125 Medical devices for use in teaching, law enforcement, research,
and analysis.
[[Page 19]]
801.127 Medical devices; expiration of exemptions.
801.128 Exceptions or alternatives to labeling requirements for medical
devices held by the Strategic National Stockpile.
Subpart E_Other Exemptions
801.150 Medical devices; processing, labeling, or repacking.
Subparts F-G [Reserved]
Subpart H_Special Requirements for Specific Devices
801.405 Labeling of articles intended for lay use in the repairing and/
or refitting of dentures.
801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
801.415 Maximum acceptable level of ozone.
800.417 Chlorofluorocarbon propellants.
801.420 Hearing aid devices; professional and patient labeling.
801.421 Hearing aid devices; conditions for sale.
801.430 User labeling for menstrual tampons.
801.433 Warning statements for prescription and restricted device
products containing or manufactured with chlorofluorocarbons
or other ozone-depleting substances.
801.435 User labeling for latex condoms.
801.437 User labeling for devices that contain natural rubber.
Authority: 21 U.S.C. 321, 331, 351, 352, 360d, 360i, 360j, 371, 374.
Source: 41 FR 6896, Feb. 13, 1976, unless otherwise noted.
Subpart A_General Labeling Provisions
Sec. 801.1 Medical devices; name and place of business of manufacturer,
packer or distributor.
(a) The label of a device in package form shall specify
conspicuously the name and place of business of the manufacturer,
packer, or distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name which may be preceded or
followed by the name of the particular division of the corporation.
Abbreviations for ``Company,'' ``Incorporated,'' etc., may be used and
``The'' may be omitted. In the case of an individual, partnership, or
association, the name under which the business is conducted shall be
used.
(c) Where a device is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such device; such as,
``Manufactured for ___'', ``Distributed by _____'', or any other wording
that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, State, and Zip Code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP Code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages, the
ZIP Code shall appear on either the label or the labeling (including the
invoice).
(e) If a person manufactures, packs, or distributes a device at a
place other than his principal place of business, the label may state
the principal place of business in lieu of the actual place where such
device was manufactured or packed or is to be distributed, unless such
statement would be misleading.
Sec. 801.3 Definitions.
As used in this part:
Automatic identification and data capture (AIDC) means any
technology that conveys the unique device identifier or the device
identifier of a device in a form that can be entered into an electronic
patient record or other computer system via an automated process.
Center Director means the Director of the Center for Devices and
Radiological Health or the Director of the Center for Biologics
Evaluation and Research, depending on which Center has been assigned
lead responsibility for the device.
Combination product has the meaning set forth in Sec. 3.2(e) of
this chapter.
Convenience kit means two or more different medical devices packaged
together for the convenience of the user.
Device package means a package that contains a fixed quantity of a
particular version or model of a device.
[[Page 20]]
Expiration date means the date by which the label of a device states
the device must or should be used.
FDA, we, or us means the Food and Drug Administration.
Finished device means any device or accessory to any device that is
suitable for use or capable of functioning.
Global Unique Device Identification Database (GUDID) means the
database that serves as a repository of information to facilitate the
identification of medical devices through their distribution and use.
Human cells, tissues, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of
this chapter that does not meet the criteria in Sec. 1271.10(a) and
that is also regulated as a device.
Implantable device means a device that is intended to be placed in a
surgically or naturally formed cavity of the human body. A device is
regarded as an implantable device for the purpose of this part only if
it is intended to remain implanted continuously for a period of 30 days
or more, unless the Commissioner of Food and Drugs determines otherwise
in order to protect human health.
Label has the meaning set forth in section 201(k) of the Federal
Food, Drug, and Cosmetic Act.
Labeler means:
(1) Any person who causes a label to be applied to a device with the
intent that the device will be commercially distributed without any
intended subsequent replacement or modification of the label; and
(2) Any person who causes the label of a device to be replaced or
modified with the intent that the device will be commercially
distributed without any subsequent replacement or modification of the
label, except that the addition of the name of, and contact information
for, a person who distributes the device, without making any other
changes to the label, is not a modification for the purposes of
determining whether a person is a labeler.
Lot or batch means one finished device or more that consist of a
single type, model, class, size, composition, or software version that
are manufactured under essentially the same conditions and that are
intended to have uniform characteristics and quality within specified
limits.
Shipping container means a container used during the shipment or
transportation of devices, and whose contents may vary from one shipment
to another.
Specification means any requirement with which a device must
conform.
Unique device identifier (UDI) means an identifier that adequately
identifies a device through its distribution and use by meeting the
requirements of Sec. 830.20 of this chapter. A unique device identifier
is composed of:
(1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
(2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured;
(v) For an HCT/P regulated as a device, the distinct identification
code required by Sec. 1271.290(c) of this chapter.
Universal product code (UPC) means the product identifier used to
identify an item sold at retail in the United States.
Version or model means all devices that have specifications,
performance, size, and composition, within limits set by the labeler.
[78 FR 58817, Sept. 24, 2013]
Sec. 801.4 Meaning of intended uses.
The words intended uses or words of similar import in Sec. Sec.
801.5, 801.119, and 801.122 refer to the objective intent of the persons
legally responsible for the labeling of devices. The intent is
determined by such persons' expressions or may be shown by the
circumstances surrounding the distribution of the article. This
objective intent may, for example, be shown by labeling claims,
advertising matter, or oral or written statements by such persons or
their representatives. It may be shown by
[[Page 21]]
the circumstances that the article is, with the knowledge of such
persons or their representatives, offered and used for a purpose for
which it is neither labeled nor advertised. The intended uses of an
article may change after it has been introduced into interstate commerce
by its manufacturer. If, for example, a packer, distributor, or seller
intends an article for different uses than those intended by the person
from whom he received the devices, such packer, distributor, or seller
is required to supply adequate labeling in accordance with the new
intended uses. But if a manufacturer knows, or has knowledge of facts
that would give him notice that a device introduced into interstate
commerce by him is to be used for conditions, purposes, or uses other
than the ones for which he offers it, he is required to provide adequate
labeling for such a device which accords with such other uses to which
the article is to be put.
Effective Date Note: At 82 FR 2217, Jan. 9, 2017, Sec. 801.4 was
revised, effective Feb. 8, 2017. At 82 FR 9501, Feb. 7, 2017, this
amendment was delayed until Mar. 21, 2017. At 82 FR 14319, Mar. 20,
2017, this amendment was further delayed until Mar. 19, 2018. At 83 FR
11639, Mar. 16, 2018 this amendment was delayed indefinitely. For the
convenience of the user, the revised text is set forth as follows:
Sec. 801.4 Meaning of intended uses.
The words intended uses or words of similar import in Sec. Sec.
801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the
objective intent of the persons legally responsible for the labeling of
devices. The intent is determined by such persons' expressions or may be
shown by the circumstances surrounding the distribution of the article.
This objective intent may, for example, be shown by labeling claims,
advertising matter, or oral or written statements by such persons or
their representatives. It may be shown, for example, by circumstances in
which the article is, with the knowledge of such persons or their
representatives, offered and used for a purpose for which it is neither
labeled nor advertised. The intended uses of an article may change after
it has been introduced into interstate commerce by its manufacturer. If,
for example, a packer, distributor, or seller intends an article for
different uses than those intended by the person from whom he received
the device, such packer, distributor, or seller is required to supply
adequate labeling in accordance with the new intended uses. And if the
totality of the evidence establishes that a manufacturer objectively
intends that a device introduced into interstate commerce by him is to
be used for conditions, purposes, or uses other than ones for which it
has been approved, cleared, granted marketing authorization, or is
exempt from premarket notification requirements (if any), he is
required, in accordance with section 502(f) of the Federal Food, Drug,
and Cosmetic Act, or, as applicable, duly promulgated regulations
exempting the device from the requirements of section 502(f)(1), to
provide for such device adequate labeling that accords with such other
intended uses.
Sec. 801.5 Medical devices; adequate directions for use.
Adequate directions for use means directions under which the layman
can use a device safely and for the purposes for which it is intended.
Section 801.4 defines intended use. Directions for use may be inadequate
because, among other reasons, of omission, in whole or in part, or
incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such
device is intended, including conditions, purposes, or uses for which it
is prescribed, recommended, or suggested in its oral, written, printed,
or graphic advertising, and conditions, purposes, or uses for which the
device is commonly used; except that such statements shall not refer to
conditions, uses, or purposes for which the device can be safely used
only under the supervision of a practitioner licensed by law and for
which it is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the
uses for which it is intended and usual quantities for persons of
different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application, in relation to time of
meals, time of onset of symptoms, or other time factors.
(f) Route or method of administration or application.
(g) Preparation for use, i.e., adjustment of temperature, or other
manipulation or process.
[[Page 22]]
Sec. 801.6 Medical devices; misleading statements.
Among representations in the labeling of a device which render such
device misbranded is a false or misleading representation with respect
to another device or a drug or food or cosmetic.
Sec. 801.15 Medical devices; prominence of required label statements;
use of symbols in labeling.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 502(c) of the act by reason, among
other reasons, of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the
container or package available for such extension, so as to provide
sufficient label space for the prominent placing of such word,
statement, or information;
(4) Insufficiency of label space for the prominent placing of such
word, statement, or information, resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space for the placing of such word,
statement, or information, resulting from the use of label space to give
materially greater conspicuousness to any other word, statement, or
information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in regulations promulgated under section 502(b) of the act,
shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or
device which is not required by or under authority of the act to appear
on the label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information than is required by section 502(c)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1)(i) All words, statements, and other information required by
or under authority of the act to appear on the label or labeling for a
device shall appear thereon in one or more of the following formats:
(A) The English language;
(B) In the case of articles distributed solely in Puerto Rico or in
a Territory where the predominant language is one other than English,
the predominant language may be substituted for English;
(C) A symbol accompanied by adjacent explanatory English text, or
text in the predominant language of the Territory, in the case of
articles distributed solely in Puerto Rico or in a Territory where the
predominant language is one other than English;
(D) A symbol not accompanied by adjacent explanatory text that:
(1) Is contained in a standard that FDA recognizes under its
authority in section 514(c) of the act;
(2) Is used according to the specifications for use of the symbol
set forth in FDA's section 514(c) recognition; and
(3) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
(E) A symbol not accompanied by adjacent explanatory text that:
[[Page 23]]
(1) Is established in a standard developed by a standards
development organization (SDO);
(2) Is not contained in a standard that is recognized by FDA under
its authority in section 514(c) of the act or is contained in a standard
that is recognized by FDA but is not used according to the
specifications for use of the symbol set forth in FDA's section 514(c)
recognition;
(3) Is determined by the manufacturer to be likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use in compliance with section 502(c) of the act;
(4) Is used according to the specifications for use of the symbol
set forth in the SDO-developed standard; and
(5) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
(F) The symbol statement ``Rx only'' or ``[rx] only'' may be used as
provided under Sec. 801.109(b)(1).
(ii) The use of symbols in device labeling which do not meet the
requirements of paragraph (c)(1)(i) of this section renders a device
misbranded under section 502(c) of the act.
(iii) For purposes of paragraph (c)(1)(i) of this section:
(A) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation is
balanced, where an appeals process is included, where the standard is
not in conflict with any statute, regulation, or policy under which FDA
operates, and where the standard is national or international in scope.
(B) The term ``symbols glossary'' means a compiled listing of:
(1) Each SDO-established symbol used in the labeling for the device;
(2) The title and designation number of the SDO-developed standard
containing the symbol;
(3) The title of the symbol and its reference number, if any, in the
standard; and
(4) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set forth
in FDA's section 514(c) recognition, the explanatory text as provided in
the standard.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language.
(3) If the labeling contains any representation in a foreign
language, all words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear on the labeling in the foreign language.
[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]
Sec. 801.16 Medical devices; Spanish-language version of certain
required statements.
If devices restricted to prescription use only are labeled solely in
Spanish for distribution in the Commonwealth of Puerto Rico where
Spanish is the predominant language, such labeling is authorized under
Sec. 801.15(c).
Sec. 801.18 Format of dates provided on a medical device label.
(a) In general. Whenever the label of a medical device includes a
printed expiration date, date of manufacture, or any other date intended
to be brought to the attention of the user of the device, the date must
be presented in the following format: The year, using four digits;
followed by the month, using two digits; followed by the day, using two
digits; each separated by hyphens. For example, January 2, 2014, must be
presented as 2014-01-02.
(b) Exceptions. (1) A combination product that properly bears a
National Drug Code (NDC) number is not subject
[[Page 24]]
to the requirements of paragraph (a) of this section.
(2) If the device is an electronic product to which a standard is
applicable under subchapter J of this chapter, Radiological Health, the
date of manufacture shall be presented as required by Sec.
1010.3(a)(2)(ii) of this chapter.
[78 FR 58818, Sept. 24, 2013]
Subpart B_Labeling Requirements for Unique Device Identification
Sec. 801.20 Label to bear a unique device identifier.
(a) In general. (1) The label of every medical device shall bear a
unique device identifier (UDI) that meets the requirements of this
subpart and part 830 of this chapter.
(2) Every device package shall bear a UDI that meets the
requirements of this subpart and part 830 of this chapter.
(b) Exceptions. Exceptions to the general rule of paragraph (a) of
this section are provided by Sec. Sec. 801.30, 801.45, and
801.128(f)(2), and Sec. 801.55 provides a means to request an exception
or alternative not provided by those provisions.
[78 FR 58818, Sept. 24, 2013]
Sec. 801.30 General exceptions from the requirement for the label
of a device to bear a unique device identifier.
(a) In general. The following types of devices are excepted from the
requirement of Sec. 801.20; a device within one or more of the
following exceptions is not required to bear a unique device identifier
(UDI):
(1) A finished device manufactured and labeled prior to the
compliance date established by FDA for Sec. 801.20 regarding the
device. This exception expires with regard to a particular device 3
years after the compliance date established by FDA for the device.
(2) A class I device that FDA has by regulation exempted from the
good manufacturing practice requirements of part 820 of this chapter,
exclusive of any continuing requirement for recordkeeping under
Sec. Sec. 820.180 and 820.198.
(3) Individual single-use devices, all of a single version or model,
that are distributed together in a single device package, intended to be
stored in that device package until removed for use, and which are not
intended for individual commercial distribution. This exception is not
available for any implantable device. The device package containing
these individual devices is not excepted from the requirement of Sec.
801.20, and must bear a UDI.
(4) A device used solely for research, teaching, or chemical
analysis, and not intended for any clinical use.
(5) A custom device within the meaning of Sec. 812.3(b) of this
chapter.
(6) An investigational device within the meaning of part 812 of this
chapter.
(7) A veterinary medical device not intended for use in the
diagnosis of disease or other conditions in man, in the cure,
mitigation, treatment, or prevention of disease in man, or intended to
affect the structure or any function of the body of man.
(8) A device intended for export from the United States.
(9) A device held by the Strategic National Stockpile and granted an
exception or alternative under Sec. 801.128(f)(2).
(10) A device for which FDA has established a performance standard
under section 514(b) of the Federal Food, Drug, and Cosmetic Act and has
provided therein an exception from the requirement of Sec. 801.20, or
for which FDA has recognized all or part of a performance standard under
section 514(c) of the Federal Food, Drug, and Cosmetic Act and has
included an exception from the requirement of Sec. 801.20 within the
scope of that recognition.
(11) A device packaged within the immediate container of a
combination product or convenience kit, provided that the label of the
combination product or convenience kit bears a UDI.
(b) National Drug Code (NDC) Numbers. If a combination product
properly bears an NDC number on its label--
(1) The combination product is not subject to the requirements of
Sec. 801.20.
(2) A device constituent of such a combination product whose
components are physically, chemically, or otherwise combined or mixed
and produced as a single entity as described by Sec. 3.2(e)(1) of this
chapter is not subject to the requirements of Sec. 801.20.
[[Page 25]]
(3) Each device constituent of such a combination product, other
than one described by Sec. 3.2(e)(1) of this chapter, must bear a UDI
on its label unless paragraph (a)(11) of this section applies.
(c) Exception for shipping containers. This rule does not require a
UDI to be placed on any shipping container.
(d) The UDI of a class I device is not required to include a
production identifier.
[78 FR 58818, Sept. 24, 2013]
Sec. 801.35 Voluntary labeling of a device with a unique device identifier.
(a) The labeler of a device that is not required to bear a unique
device identifier (UDI) may voluntarily comply with Sec. 801.20. If a
labeler voluntarily includes a UDI for a device, the labeler may
voluntarily provide information concerning the device under subpart E of
part 830 of this chapter.
(b) A device may bear both a Universal Product Code (UPC) and a UDI
on its label and packages.
[78 FR 58818, Sept. 24, 2013]
Sec. 801.40 Form of a unique device identifier.
(a) Every unique device identifier (UDI) must meet the technical
requirements of Sec. 830.20 of this chapter. The UDI must be presented
in two forms:
(1) Easily readable plain-text, and
(2) Automatic identification and data capture (AIDC) technology.
(b) The UDI must include a device identifier segment. Whenever a
device label includes a lot or batch number, a serial number, a
manufacturing date, an expiration date, or for a human cell, tissue, or
cellular or tissue-based product (HCT/P) regulated as a device, a
distinct identification code as required by Sec. 1271.290(c) of this
chapter, the UDI must include a production identifier segment that
conveys such information.
(c) If the AIDC technology is not evident upon visual examination of
the label or device package, the label or device package must disclose
the presence of AIDC technology.
(d) A class I device that bears a Universal Product Code (UPC) on
its label and device packages is deemed to meet all requirements of
subpart B of this part. The UPC will serve as the unique device
identifier required by Sec. 801.20.
[78 FR 58818, Sept. 24, 2013]
Sec. 801.45 Devices that must be directly marked with
a unique device identifier.
(a) In general. A device that must bear a unique device identifier
(UDI) on its label must also bear a permanent marking providing the UDI
on the device itself if the device is intended to be used more than once
and intended to be reprocessed before each use.
(b) UDI for direct marking. The UDI provided through a direct
marking on a device may be:
(1) Identical to the UDI that appears on the label of the device, or
(2) A different UDI used to distinguish the unpackaged device from
any device package containing the device.
(c) Form of a UDI when provided as a direct marking. When a device
must bear a UDI as a direct marking, the UDI may be provided through
either or both of the following:
(1) Easily readable plain-text;
(2) Automatic identification and data capture (AIDC) technology, or
any alternative technology, that will provide the UDI of the device on
demand.
(d) Exceptions. The requirement of paragraph (a) of this section
shall not apply to any device that meets any of the following criteria:
(1) Any type of direct marking would interfere with the safety or
effectiveness of the device;
(2) The device cannot be directly marked because it is not
technologically feasible;
(3) The device is a single-use device and is subjected to additional
processing and manufacturing for the purpose of an additional single
use.
(4) The device has been previously marked under paragraph (a) of
this section.
(e) Exception to be noted in design history file. A labeler that
decides to make use of an exception under paragraph (d of this section)
must document the basis of that decision in the design history file
required by Sec. 820.30(j) of this chapter.
[78 FR 58818, Sept. 24, 2013]
[[Page 26]]
Sec. 801.50 Labeling requirements for stand-alone software.
(a) Stand-alone software that is not distributed in packaged form
(e.g., when downloaded from a Web site) is deemed to meet the UDI
labeling requirements of this subpart if it complies with the
requirements of paragraph (b) of this section and conveys the version
number in its production identifier.
(b) Regardless of whether it is or is not distributed in packaged
form, stand-alone software regulated as a medical device must provide
its unique device identifier through either or both of the following:
(1) An easily readable plain-text statement displayed whenever the
software is started;
(2) An easily readable plain-text statement displayed through a menu
command (e.g., an ``About * * *'' command).
(c) Stand-alone software that is distributed in both packaged form
and in a form that is not packaged (e.g., when downloaded from a Web
site) may be identified with the same device identifier.
[78 FR 58818, Sept. 24, 2013]
Sec. 801.55 Request for an exception from or alternative to a unique
device identifier requirement.
(a) A labeler may submit a request for an exception from or
alternative to the requirement of Sec. 801.20 or any other requirement
of this subpart for a specified device or a specified type of device. A
written request for an exception or alternative must:
(1) Identify the device or devices that would be subject to the
exception or alternative;
(2) Identify the provisions of this subpart that are the subject of
the request for an exception or alternative;
(3) If requesting an exception, explain why you believe the
requirements of this subpart are not technologically feasible;
(4) If requesting an alternative, describe the alternative and
explain why it would provide for more accurate, precise, or rapid device
identification than the requirements of this subpart or how the
alternative would better ensure the safety or effectiveness of the
device that would be subject to the alternative;
(5) Provide, if known, the number of labelers and the number of
devices that would be affected if we grant the requested exception or
alternative; and
(6) Provide other requested information that the Center Director
needs to clarify the scope and effects of the requested exception or
alternative.
(b) A written request for an exception or alternative must be
submitted by sending it:
(1) If the device is regulated by the Center for Biologics
Evaluation and Research (CBER), by email to: [email protected]
or by correspondence to: Food and Drug Administration, Center for
Biologics Evaluation and Research, Document Control Center, 10903 New
Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993.
(2) In all other cases, by email to: [email protected], or by
correspondence to: UDI Regulatory Policy Support, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
(c) The Center Director may grant an exception or alternative,
either in response to a request or on his or her own initiative, if the
Center Director determines that an exception is appropriate because the
requirements of this subpart are not technologically feasible, or that
an alternative would provide for more accurate, precise, or rapid device
identification than the requirements of this subpart or would better
ensure the safety or effectiveness of the device that would be subject
to the alternative. If we grant an exception or alternative, we may
include any safeguards or conditions deemed appropriate to ensure the
adequate identification of the device through its distribution and use.
Any labeler may make use of an exception or alternative granted under
this section, provided that such use satisfies all safeguards or
conditions that are part of the exception or alternative.
(d) FDA may initiate and grant an exception or alternative if we
determine that the exception or alternative is in the best interest of
the public
[[Page 27]]
health. Any such exception or alternative will remain in effect only so
long as there remains a public health need for the exception or
alternative.
(e) The Center Director may rescind an exception or alternative
granted under this section if, after providing an opportunity for an
informal hearing as defined in section 201(x) of the Federal Food, Drug,
and Cosmetic Act and under part 16 of this chapter, the Center Director
determines that the exception or alternative no longer satisfies the
criteria described in this paragraph (e) or that any safeguard or
condition required under this paragraph (e) has not been met.
[78 FR 58818, Sept. 24, 2013, as amended at 80 FR 18093, Apr. 3, 2015;
81 FR 11428, Mar. 4, 2016]
Sec. 801.57 Discontinuation of legacy FDA identification numbers
assigned to devices.
(a) On the date your device must bear a unique device identifier
(UDI) on its label, any National Health-Related Item Code (NHRIC) or
National Drug Code (NDC) number assigned to that device is rescinded,
and you may no longer provide an NHRIC or NDC number on the label of
your device or on any device package.
(b) If your device is not required to bear a UDI on its label, any
NHRIC or NDC number assigned to that device is rescinded as of September
24, 2018, and beginning on that date, you may no longer provide an NHRIC
or NDC number of the label of your device or on any device package.
(c) A labeler who has been assigned an FDA labeler code to
facilitate use of NHRIC or NDC numbers may continue to use that labeler
code under a system for the issuance of UDIs, provided that--
(1) Such use is consistent with the framework of the issuing agency
that operates that system; and
(2) No later than September 24, 2014, the labeler submits, and
obtains FDA approval of, a request for continued use of the assigned
labeler code. A request for continued use of an assigned labeler code
must be submitted by email to: [email protected], or by
correspondence to: UDI Regulatory Policy Support, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3303, Silver Spring, MD 20993-0002.
(d) Each request for continued use of an assigned labeler code must
provide--
(1) The name, mailing address, email address, and phone number of
the labeler who is currently using the labeler code;
(2) The owner/operator account identification used by the labeler to
submit registration and listing information using FDA's Unified
Registration and Listing System (FURLS).
(3) The FDA labeler code that the labeler wants to continue using.
[78 FR 58820, Sept. 24, 2013, as amended at 81 FR 11428, Mar. 4, 2016]
Subpart C_Labeling Requirements for Over-the-Counter Devices
Sec. 801.60 Principal display panel.
The term principal display panel, as it applies to over-the-counter
devices in package form and as used in this part, means the part of a
label that is most likely to be displayed, presented, shown, or examined
under customary conditions of display for retail sale. The principal
display panel shall be large enough to accommodate all the mandatory
label information required to be placed thereon by this part with
clarity and conspicuousness and without obscuring designs, vignettes, or
crowding. Where packages bear alternate principal display panels,
information required to be placed on the principal display panel shall
be duplicated on each principal display panel. For the purpose of
obtaining uniform type size in declaring the quantity of contents for
all packages of substantially the same size, the term area of the
principal display panel means the area of the side or surface that bears
the principal display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent
[[Page 28]]
of the product of the height of the container times the circumference;
and
(c) In the case of any other shape of container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious ``principal display panel'' such as the
top of a triangular or circular package, the area shall consist of the
entire top surface.
In determining the area of the principal display panel, exclude tops,
bottoms, flanges at the tops and bottoms of cans, and shoulders and
necks of bottles or jars. In the case of cylindrical or nearly
cylindrical containers, information required by this part to appear on
the principal display panel shall appear within that 40 percent of the
circumference which is most likely to be displayed, presented, shown, or
examined under customary conditions of display for retail sale.
Sec. 801.61 Statement of identity.
(a) The principal display panel of an over-the-counter device in
package form shall bear as one of its principal features a statement of
the identity of the commodity.
(b) Such statement of identity shall be in terms of the common name
of the device followed by an accurate statement of the principal
intended action(s) of the device. Such statement shall be placed in
direct conjunction with the most prominent display of the name and shall
employ terms descriptive of the principal intended action(s). The
indications for use shall be included in the directions for use of the
device, as required by section 502(f)(1) of the act and by the
regulations in this part.
(c) The statement of identity shall be presented in bold face type
on the principal display panel, shall be in a size reasonably related to
the most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
Sec. 801.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter device in package form shall
bear a declaration of the net quantity of contents. This shall be
expressed in the terms of weight, measure, numerical count, or a
combination of numerical count and weight, measure, or size: Provided,
That:
(1) In the case of a firmly established general consumer usage and
trade custom of declaring the quantity of a device in terms of linear
measure or measure of area, such respective term may be used. Such term
shall be augmented when necessary for accuracy of information by a
statement of the weight, measure, or size of the individual units or of
the entire device.
(2) If the declaration of contents for a device by numerical count
does not give accurate information as to the quantity of the device in
the package, it shall be augmented by such statement of weight, measure,
or size of the individual units or of the total weight, measure, or size
of the device as will give such information; for example, ``100 tongue
depressors, adult size'', ``1 rectal syringe, adult size'', etc.
Whenever the Commissioner determines for a specific packaged device that
an existing practice of declaring net quantity of contents by weight,
measure, numerical count, or a combination of these does not facilitate
value comparisions by consumers, he shall by regulation designate the
appropriate term or terms to be used for such article.
(b) Statements of weight of the contents shall be expressed in terms
of avoirdupois pound and ounce. A statement of liquid measure of the
contents shall be expressed in terms of the U.S. gallon of 231 cubic
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall
express the volume at 68 [deg]F (20 [deg]C). See also paragraph (p) of
this section.
(c) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eighths,
sixteenths, or thirty-seconds; except that if there exists a firmly
established, general consumer usage and trade custom of employing
different common fractions in the net quantity declaration of a
particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried out
to more than two places. A statement that includes
[[Page 29]]
small fractions of an ounce shall be deemed to permit smaller variations
than one which does not include such fractions.
(d) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(e) The declaration shall appear as a distinct item on the principal
display panel, shall be separated, by at least a space equal to the
height of the lettering used in the declaration, from other printed
label information appearing above or below the declaration and, by at
least a space equal to twice the width of the letter ``N'' of the style
of type used in the quantity of contents statement, from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count, such as ``giant pint'' and ``full quart'', that tends to
exaggerate. It shall be placed on the principal display panel within the
bottom 30 percent of the area of the label panel in lines generally
parallel to the base on which the package rests as it is designed to be
displayed: Provided, That:
(1) On packages having a principal display panel of 5 square inches
or less the requirement for placement within the bottom 30 percent of
the area of the label panel shall not apply when the declaration of net
quantity of contents meets the other requirements of this part; and
(2) In the case of a device that is marketed with both outer and
inner retail containers bearing the mandatory label information required
by this part and the inner container is not intended to be sold
separately, the net quantity of contents placement requirement of this
section applicable to such inner container is waived.
(3) The principal display panel of a device marketed on a display
card to which the immediate container is affixed may be considered to be
the display panel of the card, and the type size of the net quantity of
contents statement is governed by the dimensions of the display card.
(f) The declaration shall accurately reveal the quantity of device
in the package exclusive of wrappers and other material packed
therewith.
(g) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of net quantity blown, embossed, or molded on a glass
or plastic surface is permissible when all label information is so
formed on the surface. Requirements of conspicuousness and legibility
shall include the specifications that:
(1) The ratio of height to width of the letter shall not exceed a
differential of 3 units to 1 unit, i.e., no more than 3 times as high as
it is wide.
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ``o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
(h) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(1) Not less than one-sixteenth inch in height on packages the
principal display panel of which has an area of 5 square inches or less.
(2) Not less than one-eighth inch in height on packages the
principal display panel of which has an area of more than 5 but not more
than 25 square inches.
(3) Not less than three-sixteenths inch in height on packages the
principal display panel of which has an area of more than 25 but not
more than 100 square inches.
(4) Not less than one-fourth inch in height on packages the
principal display panel of which has an area of more than 100 square
inches, except not less than one-half inch in height if the area is more
than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes
[[Page 30]]
specified in paragraphs (h)(1) through (4) of this section shall be
increased by one-sixteenth of an inch.
(i) On packages containing less than 4 pounds or 1 gallon and
labeled in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(k) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples set forth in
paragraphs (k) (3) and (4) of this section). If the net weight of the
package is less than 1 ounce avoirdupois or the net fluid measure is
less than 1 fluid ounce, the declaration shall be in terms of common or
decimal fractions of the respective ounce and not in terms of drams.
(2) The declaration may appear in more than one line. The term ``net
weight'' shall be used when stating the net quantity of contents in
terms of weight. Use of the terms ``net'' or ``net contents'' in terms
of fluid measure or numerical count is optional. It is sufficient to
distinguish avoirdupois ounce from fluid ounce through association of
terms; for example, ``Net wt. 6 oz'' or ``6 oz net wt.,'' and ``6 fl
oz'' or ``net contents 6 fl oz.''
(j) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common or decimal fractions of the pound; in the case of fluid measure,
it shall be expressed in the largest whole unit, i.e., gallons, followed
by common or decimal fractions of a gallon or by the next smaller whole
unit or units (quarts or quarts and pints), with any remainder in terms
of fluid ounces or common or decimal fractions of the pint or quart; see
paragraph (k)(5) of this section.
(k) Examples: (1) A declaration of 1\1/2\ pounds weight shall be
expressed as ``net wt. 24 oz (1 lb 8 oz),'' or ``Net wt. 24 oz (1\1/2\
lb)'' or ``Net wt. 24 oz (1.5 lb).''
(2) A declaration of three-fourths pound avoirdupois weight shall be
expressed as ``Net wt. 12 oz.''.
(3) A declaration of 1 quart liquid measure shall be expressed as
``Net contents 32 fl oz (1 qt)'' or ``32 fl oz (1 qt).''
(4) A declaration of 1\3/4\ quarts liquid measure shall be expressed
as, ``Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ``Net contents 56 fl
oz (1 qt 1.5 pt),'' but not in terms of quart and ounce such as ``Net
contents 56 fl oz (1 qt 24 oz).''
(5) A declaration of 2\1/2\ gallons liquid measure shall be
expressed as ``Net contents 2 gal 2 qt'', ``Net contents 2.5 gallons,''
or ``Net contents 2\1/2\ gal'' but not as ``2 gal 4 pt''.
(l) For quantities, the following abbreviations and none other may
be employed. Periods and plural forms are optional:
gallon gal liter l
milliliter ml cubic centimeter cc
quart qt yard yd
pint pt feet or foot ft
ounce oz inch in
pound lb meter m
grain gr centimeter cm
kilogram kg millimeter mm
gram g fluid fl
milligram mg square sq
microgram mcg weight wt
(m) On packages labeled in terms of linear measure, the declaration
shall be expressed both in terms of inches and, if applicable (1 foot or
more), the largest whole units (yards, yards and feet, feet). The
declaration in terms of the largest whole units shall be in parentheses
following the declaration in terms of inches and any remainder shall be
in terms of inches or common or decimal fractions of the foot or yard;
if applicable, as in the case of adhesive tape, the initial declaration
in linear inches shall be preceded by a statement of the width. Examples
of linear measure are ``86 inches (2 yd 1 ft 2 in)'', ``90 inches (2\1/
2\ yd)'', ``30 inches (2.5 ft)'', ``\3/4\ inch by 36 in (1 yd)'', etc.
(n) On packages labeled in terms of area measure, the declaration
shall be expressed both in terms of square inches and, if applicable (1
square foot or more), the largest whole square unit (square yards,
square yards and square
[[Page 31]]
feet, square feet). The declaration in terms of the largest whole units
shall be in parentheses following the declaration in terms of square
inches and any remainder shall be in terms of square inches or common or
decimal fractions of the square foot or square yard; for example, ``158
sq inches (1 sq ft 14 sq in)''.
(o) Nothing in this section shall prohibit supplemental statements
at locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents, provided that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the device contained in the package; for
example, ``giant pint'' and ``full quart''. Dual or combination
declarations of net quantity of contents as provided for in paragraphs
(a) and (i) of this section are not regarded as supplemental net
quantity statements and shall be located on the principal display panel.
(p) A separate statement of net quantity of contents in terms of the
metric system of weight or measure is not regarded as a supplemental
statement and an accurate statement of the net quantity of contents in
terms of the metric system of weight or measure may also appear on the
principal display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
Sec. 801.63 Medical devices; warning statements for devices containing
or manufactured with chlorofluorocarbons and other class I
ozone-depleting substances.
(a) All over-the-counter devices containing or manufactured with
chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or
any other class I substance designated by the Environmental Protection
Agency (EPA) shall carry one of the following warnings:
(1) The EPA warning statement:
Warning: Contains [or Manufactured with, if applicable] [insert name
of substance], a substance which harms public health and environment by
destroying ozone in the upper atmosphere.
(2) The alternative statement:
Note: The indented statement below is required by the Federal
government's Clean Air Act for all products containing or manufactured
with chlorofluorocarbons (CFC's) [or other class I substance, if
applicable]:
Warning: Contains [or Manufactured with, if applicable] [insert name
of substance], a substance which harms public health and environment by
destroying ozone in the upper atmosphere.
CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF YOU
HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.
(b) The warning statement shall be clearly legible and conspicuous
on the product, its immediate container, its outer packaging, or other
labeling in accordance with the requirements of 40 CFR part 82 and
appear with such prominence and conspicuousness as to render it likely
to be read and understood by consumers under normal conditions of
purchase. This provision does not replace or relieve a person from any
requirements imposed under 40 CFR part 82.
[61 FR 20101, May 3, 1996]
Subpart D_Exemptions From Adequate Directions for Use
Sec. 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or
the method of its use, or the collateral measures necessary to its use
is not safe except under the supervision of a practitioner licensed by
law to direct the use of such device, and hence for which ``adequate
directions for use'' cannot be prepared, shall be exempt from section
502(f)(1) of the act if all the following conditions are met:
(a) The device is:
(1)(i) In the possession of a person, or his agents or employees,
regularly and lawfully engaged in the manufacture,
[[Page 32]]
transportation, storage, or wholesale or retail distribution of such
device; or
(ii) In the possession of a practitioner, such as physicians,
dentists, and veterinarians, licensed by law to use or order the use of
such device; and
(2) Is to be sold only to or on the prescription or other order of
such practitioner for use in the course of his professional practice.
(b) The label of the device, other than surgical instruments, bears:
(1) The symbol statement ``Rx only'' or ``[rx] only'' or the
statement ``Caution: Federal law restricts this device to sale by or on
the order of a ___'', the blank to be filled with the word
``physician'', ``dentist'', ``veterinarian'', or with the descriptive
designation of any other practitioner licensed by the law of the State
in which the practitioner practices to use or order the use of the
device; and
(2) The method of its application or use.
(c) Labeling on or within the package from which the device is to be
dispensed bears information for use, including indications, effects,
routes, methods, and frequency and duration of administration, and any
relevant hazards, contraindications, side effects, and precautions under
which practitioners licensed by law to administer the device can use the
device safely and for the purpose for which it is intended, including
all purposes for which it is advertised or represented: Provided,
however, That such information may be omitted from the dispensing
package if, but only if, the article is a device for which directions,
hazards, warnings, and other information are commonly known to
practitioners licensed by law to use the device. Upon written request,
stating reasonable grounds therefor, the Commissioner will offer an
opinion on a proposal to omit such information from the dispensing
package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether
or not it is on or within a package from which the device is to be
dispensed, distributed by or on behalf of the manufacturer, packer, or
distributor of the device, that furnishes or purports to furnish
information for use of the device contains adequate information for such
use, including indications, effects, routes, methods, and frequency and
duration of administration and any relevant hazards, contraindications,
side effects, and precautions, under which practitioners licensed by law
to employ the device can use the device safely and for the purposes for
which it is intended, including all purposes for which it is advertised
or represented. This information will not be required on so-called
reminder--piece labeling which calls attention to the name of the device
but does not include indications or other use information.
(e) All labeling, except labels and cartons, bearing information for
use of the device also bears the date of the issuance or the date of the
latest revision of such labeling.
[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]
Sec. 801.110 Retail exemption for prescription devices.
A device subject to Sec. 801.109 shall be exempt at the time of
delivery to the ultimate purchaser or user from section 502(f)(1) of the
act if it is delivered by a licensed practitioner in the course of his
professional practice or upon a prescription or other order lawfully
issued in the course of his professional practice, with labeling bearing
the name and address of such licensed practitioner and the directions
for use and cautionary statements, if any, contained in such order.
Sec. 801.116 Medical devices having commonly known directions.
A device shall be exempt from section 502(f)(1) of the act insofar
as adequate directions for common uses thereof are known to the ordinary
individual.
Sec. 801.119 In vitro diagnostic products.
A product intended for use in the diagnosis of disease and which is
an in vitro diagnostic product as defined in Sec. 809.3(a) of this
chapter shall be deemed to be in compliance with the requirements of
this part and section 502(f)(1) of the Federal Food, Drug, and
[[Page 33]]
Cosmetic Act if it meets the requirements of subpart B of this part and
the requirements of Sec. 809.10 of this chapter.
[78 FR 58820, Sept. 24, 2013]
Sec. 801.122 Medical devices for processing, repacking, or manufacturing.
A device intended for processing, repacking, or use in the
manufacture of another drug or device shall be exempt from section
502(f)(1) of the act if its label bears the statement ``Caution: For
manufacturing, processing, or repacking''.
Sec. 801.125 Medical devices for use in teaching, law enforcement,
research, and analysis.
A device subject to Sec. 801.109 shall be exempt from section
502(f)(1) of this act if shipped or sold to, or in the possession of,
persons regularly and lawfully engaged in instruction in pharmacy,
chemistry, or medicine not involving clinical use, or engaged in law
enforcement, or in research not involving clinical use, or in chemical
analysis, or physical testing, and is to be used only for such
instruction, law enforcement, research, analysis, or testing.
Sec. 801.127 Medical devices; expiration of exemptions.
(a) If a shipment or delivery, or any part thereof, of a device
which is exempt under the regulations in this section is made to a
person in whose possession the article is not exempt, or is made for any
purpose other than those specified, such exemption shall expire, with
respect to such shipment or delivery or part thereof, at the beginning
of that shipment or delivery. The causing of an exemption to expire
shall be considered an act which results in such device being misbranded
unless it is disposed of under circumstances in which it ceases to be a
drug or device.
(b) The exemptions conferred by Sec. Sec. 801.119, 801.122, and
801.125 shall continue until the devices are used for the purposes for
which they are exempted, or until they are relabeled to comply with
section 502(f)(1) of the act. If, however, the device is converted, or
manufactured into a form limited to prescription dispensing, no
exemption shall thereafter apply to the article unless the device is
labeled as required by Sec. 801.109.
Sec. 801.128 Exceptions or alternatives to labeling requirements
for medical devices held by the Strategic National Stockpile.
(a) The appropriate FDA Center Director may grant an exception or
alternative to any provision listed in paragraph (f) of this section and
not explicitly required by statute, for specified lots, batches, or
other units of a medical device, if the Center Director determines that
compliance with such labeling requirement could adversely affect the
safety, effectiveness, or availability of such devices that are or will
be included in the Strategic National Stockpile.
(b)(1)(i) A Strategic National Stockpile official or any entity that
manufactures (including labeling, packing, relabeling, or repackaging),
distributes, or stores devices that are or will be included in the
Strategic National Stockpile may submit, with written concurrence from a
Strategic National Stockpile official, a written request for an
exception or alternative described in paragraph (a) of this section to
the Center Director.
(ii) The Center Director may grant an exception or alternative
described in paragraph (a) of this section on his or her own initiative.
(2) A written request for an exception or alternative described in
paragraph (a) of this section must:
(i) Identify the specified lots, batches, or other units of the
medical device that would be subject to the exception or alternative;
(ii) Identify the labeling provision(s) listed in paragraph (f) of
this section that are the subject of the exception or alternative
request;
(iii) Explain why compliance with the labeling provision(s) could
adversely affect the safety, effectiveness, or availability of the
specified lots, batches, or other units of a medical device that are or
will be held in the Strategic National Stockpile;
(iv) Describe any proposed safeguards or conditions that will be
implemented so that the labeling of the device includes appropriate
information necessary for the safe and effective use of
[[Page 34]]
the device, given the anticipated circumstances of use of the device;
(v) Provide a draft of the proposed labeling of the specified lots,
batches, or other units of the medical device subject to the exception
or alternative; and
(vi) Provide any other information requested by the Center Director
in support of the request.
(c) The Center Director must respond in writing to all requests
under this section. The Center Director may impose appropriate
conditions when granting such an exception or alternative under this
section.
(d) A grant of an exception or alternative under this section will
include any safeguards or conditions deemed appropriate by the Center
Director so that the labeling of devices subject to the exception or
alternative includes the information necessary for the safe and
effective use of the device, given the anticipated circumstances of use.
(e) If the Center Director grants a request for an exception or
alternative to the labeling requirements under this section:
(1) The Center Director may determine that the submission and grant
of a written request under this section satisfies the provisions
relating to premarket notification submissions under Sec. 807.81(a)(3)
of this chapter.
(2)(i) For a Premarket Approval Application (PMA)-approved device,
the submission and grant of a written request under this section
satisfies the provisions relating to submission of PMA supplements under
Sec. 814.39 of this chapter; however,
(ii) The grant of the request must be identified in a periodic
report under Sec. 814.84 of this chapter.
(f) The Center Director may grant an exception or alternative under
this section to the following provisions of this chapter, to the extent
that the requirements in these provisions are not explicitly required by
statute:
(1) Sec. 801.1(d);
(2) Subpart B of this part and part 830 of this chapter in its
entirety;
(3) Sec. 801.60;
(4) Sec. 801.61;
(5) Sec. 801.62;
(6) Sec. 801.63;
(7) Sec. 801.109; and
(8) Part 801, subpart H.
[72 FR 73601, Dec. 28, 2007, as amended at 78 FR 58820, Sept. 24, 2013]
Subpart E_Other Exemptions
Sec. 801.150 Medical devices; processing, labeling, or repacking.
(a) Except as provided by paragraphs (b) and (c) of this section, a
shipment or other delivery of a device which is, in accordance with the
practice of the trade, to be processed, labeled, or repacked, in
substantial quantity at an establishment other than that where
originally processed or packed, shall be exempt, during the time of
introduction into and movement in interstate commerce and the time of
holding in such establishment, from compliance with the labeling and
packaging requirements of section 502(b) and (f) of the act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such
device is to be processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or
delivery is made to such establishment under a written agreement, signed
by and containing the post office addresses of such person and such
operator, and containing such specifications for the processing,
labeling, or repacking, as the case may be, of such device in such
establishment as will insure, if such specifications are followed, that
such device will not be adulterated or misbranded within the meaning of
the act upon completion of such processing, labeling, or repacking. Such
person and such operator shall each keep a copy of such agreement until
2 years after the final shipment or delivery of such device from such
establishment, and shall make such copies available for inspection at
any reasonable hour to any officer or employee of the Department who
requests them.
(b) An exemption of a shipment or other delivery of a device under
paragraph (a)(1) of this section shall, at the beginning of the act of
removing such shipment or delivery, or any part thereof, from such
establishment, become void ab initio if the device comprising such
shipment, delivery, or part
[[Page 35]]
is adulterated or misbranded within the meaning of the act when so
removed.
(c) An exemption of a shipment or other delivery of a device under
paragraph (a)(2) of this section shall become void ab initio with
respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by such paragraph
(a)(2).
(d) An exemption of a shipment or other delivery of a device under
paragraph (a)(2) of this section shall expire:
(1) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the device
comprising such shipment, delivery, or part is adulterated or misbranded
within the meaning of the act when so removed; or
(2) Upon refusal by the operator of the establishment where such
device is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such clause.
(e) As it is a common industry practice to manufacture and/or
assemble, package, and fully label a device as sterile at one
establishment and then ship such device in interstate commerce to
another establishment or to a contract sterilizer for sterilization, the
Food and Drug Administration will initiate no regulatory action against
the device as misbranded or adulterated when the nonsterile device is
labeled sterile, provided all the following conditions are met:
(1) There is in effect a written agreement which:
(i) Contains the names and post office addresses of the firms
involved and is signed by the person authorizing such shipment and the
operator or person in charge of the establishment receiving the devices
for sterilization.
(ii) Provides instructions for maintaining proper records or
otherwise accounting for the number of units in each shipment to insure
that the number of units shipped is the same as the number received and
sterilized.
(iii) Acknowledges that the device is nonsterile and is being
shipped for further processing, and
(iv) States in detail the sterilization process, the gaseous mixture
or other media, the equipment, and the testing method or quality
controls to be used by the contract sterilizer to assure that the device
will be brought into full compliance with the Federal Food, Drug, and
Cosmetic Act.
(2) Each pallet, carton, or other designated unit is conspicuously
marked to show its nonsterile nature when it is introduced into and is
moving in interstate commerce, and while it is being held prior to
sterilization. Following sterilization, and until such time as it is
established that the device is sterile and can be released from
quarantine, each pallet, carton, or other designated unit is
conspicuously marked to show that it has not been released from
quarantine, e.g., ``sterilized--awaiting test results'' or an equivalent
designation.
Subparts F-G [Reserved]
Subpart H_Special Requirements for Specific Devices
Sec. 801.405 Labeling of articles intended for lay use in the repairing
and/or refitting of dentures.
(a) The American Dental Association and leading dental authorities
have advised the Food and Drug Administration of their concern regarding
the safety of denture reliners, repair kits, pads, cushions, and other
articles marketed and labeled for lay use in the repairing, refitting,
or cushioning of ill-fitting, broken, or irritating dentures. It is the
opinion of dental authorities and the Food and Drug Administration that
to properly repair and properly refit dentures a person must have
professional knowledge and specialized technical skill. Laymen cannot be
expected to maintain the original vertical dimension of occlusion and
the centric relation essential in the proper repairing or refitting of
dentures. The continued wearing of improperly repaired or refitted
dentures may cause acceleration of bone resorption, soft tissue
hyperplasia, and other irreparable damage to the oral cavity. Such
articles designed for lay use should be
[[Page 36]]
limited to emergency or temporary situations pending the services of a
licensed dentist.
(b) The Food and Drug Administration therefore regards such articles
as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act,
unless the labeling:
(1)(i) Limits directions for use for denture repair kits to
emergency repairing pending unavoidable delay in obtaining professional
reconstruction of the denture;
(ii) Limits directions for use for denture reliners, pads, and
cushions to temporary refitting pending unavoidable delay in obtaining
professional reconstruction of the denture;
(2) Contains in a conspicuous manner the word ``emergency''
preceding and modifying each indication-for-use statement for denture
repair kits and the word ``temporary'' preceding and modifying each
indication-for-use statement for reliners, pads, and cushions; and
(3) Includes a conspicuous warning statement to the effect:
(i) For denture repair kits: ``Warning--For emergency repairs only.
Long term use of home-repaired dentures may cause faster bone loss,
continuing irritation, sores, and tumors. This kit for emergency use
only. See Dentist Without Delay.''
(ii) For denture reliners, pads, and cushions: ``Warning--For
temporary use only. Longterm use of this product may lead to faster bone
loss, continuing irritation, sores, and tumors. For Use Only Until a
Dentist Can Be Seen.''
(c) Adequate directions for use require full information of the
temporary and emergency use recommended in order for the layman to
understand the limitations of usefulness, the reasons therefor, and the
importance of adhering to the warnings. Accordingly, the labeling should
contain substantially the following information:
(1) For denture repair kits: Special training and tools are needed
to repair dentures to fit properly. Home-repaired dentures may cause
irritation to the gums and discomfort and tiredness while eating. Long
term use may lead to more troubles, even permanent changes in bones,
teeth, and gums, which may make it impossible to wear dentures in the
future. For these reasons, dentures repaired with this kit should be
used only in an emergency until a dentist can be seen. Dentures that
don't fit properly cause irritation and injury to the gums and faster
bone loss, which is permanent. Dentures that don't fit properly cause
gum changes that may require surgery for correction. Continuing
irritation and injury may lead to cancer in the mouth. You must see your
dentist as soon as possible.
(2) For denture reliners, pads, and cushions: Use of these
preparations or devices may temporarily decrease the discomfort;
however, their use will not make the denture fit properly. Special
training and tools are needed to repair a denture to fit properly.
Dentures that do not fit properly cause irritation and injury to the
gums and faster bone loss, which is permanent and may require a
completely new denture. Changes in the gums caused by dentures that do
not fit properly may require surgery for correction. Continuing
irritation and injury may lead to cancer in the mouth. You must see your
dentist as soon as possible.
(3) If the denture relining or repairing material forms a permanent
bond with the denture, a warning statement to the following effect
should be included: ``This reliner becomes fixed to the denture and a
completely new denture may be required because of its use.''
(d) Labeling claims exaggerating the usefulness or the safety of the
material or failing to disclose all facts relevant to the claims of
usefulness will be regarded as false and misleading under sections
201(n) and 502(a) of the Federal Food, Drug, and Cosmetic Act.
(e) Regulatory action may be initiated with respect to any article
found within the jurisdiction of the act contrary to the provisions of
this policy statement after 90 days following the date of publication of
this section in the Federal Register.
Sec. 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.
(a) Examination of data available on the frequency of eye injuries
resulting from the shattering of ordinary crown glass lenses indicates
that the use of
[[Page 37]]
such lenses constitutes an avoidable hazard to the eye of the wearer.
(b) The consensus of the ophthalmic community is that the number of
eye injuries would be substantially reduced by the use in eyeglasses and
sunglasses of impact-resistant lenses.
(c)(1) To protect the public more adequately from potential eye
injury, eyeglasses and sunglasses must be fitted with impact-resistant
lenses, except in those cases where the physician or optometrist finds
that such lenses will not fulfill the visual requirements of the
particular patient, directs in writing the use of other lenses, and
gives written notification thereof to the patient.
(2) The physician or optometrist shall have the option of ordering
glass lenses, plastic lenses, or laminated glass lenses made impact
resistant by any method; however, all such lenses shall be capable of
withstanding the impact test described in paragraph (d)(2) of this
section.
(3) Each finished impact-resistant glass lens for prescription use
shall be individually tested for impact resistance and shall be capable
of withstanding the impact test described in paragraph (d)(2) of this
section. Raised multifocal lenses shall be impact resistant but need not
be tested beyond initial design testing. Prism segment multifocal, slab-
off prism, lenticular cataract, iseikonic, depressed segment one-piece
multifocal, bioconcave, myodisc and minus lenticular, custom laminate
and cemented assembly lenses shall be impact resistant but need not be
subjected to impact testing. To demonstrate that all other types of
impact-resistant lenses, including impact-resistant laminated glass
lenses (i.e., lenses other than those described in the three preceding
sentences of this paragraph (c)(3)), are capable of withstanding the
impact test described in this regulation, the manufacturer of these
lenses shall subject to an impact test a statistically significant
sampling of lenses from each production batch, and the lenses so tested
shall be representative of the finished forms as worn by the wearer,
including finished forms that are of minimal lens thickness and have
been subjected to any treatment used to impart impact resistance. All
nonprescription lenses and plastic prescription lenses tested on the
basis of statistical significance shall be tested in uncut-finished or
finished form.
(d)(1) For the purpose of this regulation, the impact test described
in paragraph (d)(2) of this section shall be the ``referee test,''
defined as ``one which will be utilized to determine compliance with a
regulation.'' The referee test provides the Food and Drug Administration
with the means of examining a medical device for performance and does
not inhibit the manufacturer from using equal or superior test methods.
A lens manufacturer shall conduct tests of lenses using the impact test
described in paragraph (d)(2) of this section or any equal or superior
test. Whatever test is used, the lenses shall be capable of withstanding
the impact test described in paragraph (d)(2) of this section if the
Food and Drug Administration examines them for performance.
(2) In the impact test, a \5/8\-inch steel ball weighing
approximately 0.56 ounce is dropped from a height of 50 inches upon the
horizontal upper surface of the lens. The ball shall strike within a \5/
8\-inch diameter circle located at the geometric center of the lens. The
ball may be guided but not restricted in its fall by being dropped
through a tube extending to within approximately 4 inches of the lens.
To pass the test, the lens must not fracture; for the purpose of this
section, a lens will be considered to have fractured if it cracks
through its entire thickness, including a laminar layer, if any, and
across a complete diameter into two or more separate pieces, or if any
lens material visible to the naked eyes becomes detached from the ocular
surface. The test shall be conducted with the lens supported by a tube
(1-inch inside diameter, 1\1/4\-inch outside diameter, and approximately
1-inch high) affixed to a rigid iron or steel base plate. The total
weight of the base plate and its rigidly attached fixtures shall be not
less than 27 pounds. For lenses of small minimum diameter, a support
tube having an outside diameter of less than 1\1/4\ inches may be used.
The support tube shall be made of rigid acrylic plastic, steel, or other
suitable substance and
[[Page 38]]
shall have securely bonded on the top edge a \1/8\- by \1/8\-inch
neoprene gasket having a hardness of 40 5, as
determined by ASTM Method D 1415-88, ``Standard Test Method for Rubber
Property--International Hardness'' a minimum tensile strength of 1,200
pounds, as determined by ASTM Method D 412-98A, ``Standard Test Methods
for Vulcanized Rubber and Thermoplastic Elastomers--Tension,'' and a
minimum ultimate elongation of 400 percent, as determined by ASTM Method
D 412-68 (Both methods are incorporated by reference and are available
from the American Society for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428, or available for inspection
at the Center for Devices and Radiological Health's Library, 9200
Corporate Blvd., Rockville, MD 20850, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html. The diameter or contour of the lens support may be
modified as necessary so that the \1/8\- by \1/8\-inch neoprene gasket
supports the lens at its periphery.
(e) Copies of invoice(s), shipping document(s), and records of sale
or distribution of all impact resistant lenses, including finished
eyeglasses and sunglasses, shall be kept and maintained for a period of
3 years; however, the names and addresses of individuals purchasing
nonprescription eyeglasses and sunglasses at the retail level need not
be kept and maintained by the retailer. The records kept in compliance
with this paragraph shall be made available upon request at all
reasonable hours by any officer or employee of the Food and Drug
Administration or by any other officer or employee acting on behalf of
the Secretary of Health and Human Services and such officer or employee
shall be permitted to inspect and copy such records, to make such
inventories of stock as he deems necessary, and otherwise to check the
correctness of such inventories.
(f) In addition, those persons conducting tests in accordance with
paragraph (d) of this section shall maintain the results thereof and a
description of the test method and of the test apparatus for a period of
3 years. These records shall be made available upon request at any
reasonable hour by any officer or employee acting on behalf of the
Secretary of Health and Human Services. The persons conducting tests
shall permit the officer or employee to inspect and copy the records, to
make such inventories of stock as the officer or employee deems
necessary, and otherwise to check the correctness of the inventories.
(g) For the purpose of this section, the term ``manufacturer''
includes an importer for resale. Such importer may have the tests
required by paragraph (d) of this section conducted in the country of
origin but must make the results thereof available, upon request, to the
Food and Drug Administration, as soon as practicable.
(h) All lenses must be impact-resistant except when the physician or
optometrist finds that impact-resistant lenses will not fulfill the
visual requirements for a particular patient.
(i) This statement of policy does not apply to contact lenses.
[41 FR 6896, Feb. 13, 1976, as amended at 44 FR 20678, Apr. 6, 1979; 47
FR 9397, Mar. 5, 1982; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18,
2000; 69 FR 18803, Apr. 9, 2004]
Sec. 801.415 Maximum acceptable level of ozone.
(a) Ozone is a toxic gas with no known useful medical application in
specific, adjunctive, or preventive therapy. In order for ozone to be
effective as a germicide, it must be present in a concentration far
greater than that which can be safely tolerated by man and animals.
(b) Although undesirable physiological effects on the central
nervous system, heart, and vision have been reported, the predominant
physiological effect of ozone is primary irritation of the mucous
membranes. Inhalation of ozone can cause sufficient irritation to the
lungs to result in pulmonary edema. The onset of pulmonary edema is
usually delayed for some hours after exposure; thus, symptomatic
response is not a reliable warning of exposure to toxic concentrations
of ozone. Since olfactory fatigue develops readily, the
[[Page 39]]
odor of ozone is not a reliable index of atmospheric ozone
concentration.
(c) A number of devices currently on the market generate ozone by
design or as a byproduct. Since exposure to ozone above a certain
concentration can be injurious to health, any such device will be
considered adulterated and/or misbranded within the meaning of sections
501 and 502 of the act if it is used or intended for use under the
following conditions:
(1) In such a manner that it generates ozone at a level in excess of
0.05 part per million by volume of air circulating through the device or
causes an accumulation of ozone in excess of 0.05 part per million by
volume of air (when measured under standard conditions at 25 [deg]C (77
[deg]F) and 760 millimeters of mercury) in the atmosphere of enclosed
space intended to be occupied by people for extended periods of time,
e.g., houses, apartments, hospitals, and offices. This applies to any
such device, whether portable or permanent or part of any system, which
generates ozone by design or as an inadvertent or incidental product.
(2) To generate ozone and release it into the atmosphere in
hospitals or other establishments occupied by the ill or infirm.
(3) To generate ozone and release it into the atmosphere and does
not indicate in its labeling the maximum acceptable concentration of
ozone which may be generated (not to exceed 0.05 part per million by
volume of air circulating through the device) as established herein and
the smallest area in which such device can be used so as not to produce
an ozone accumulation in excess of 0.05 part per million.
(4) In any medical condition for which there is no proof of safety
and effectiveness.
(5) To generate ozone at a level less than 0.05 part per million by
volume of air circulating through the device and it is labeled for use
as a germicide or deodorizer.
(d) This section does not affect the present threshold limit value
of 0.10 part per million (0.2 milligram per cubic meter) of ozone
exposure for an 8-hour-day exposure of industrial workers as recommended
by the American Conference of Governmental Industrial Hygienists.
(e) The method and apparatus specified in 40 CFR part 50, or any
other equally sensitive and accurate method, may be employed in
measuring ozone pursuant to this section.
Sec. 801.417 Chlorofluorocarbon propellants.
The use of chlorofluorocarbon in devices as propellants in self-
pressurized containers is generally prohibited except as provided in
Sec. 2.125 of this chapter.
[43 FR 11318, Mar. 17, 1978]
Sec. 801.420 Hearing aid devices; professional and patient labeling.
(a) Definitions for the purposes of this section and Sec. 801.421.
(1) Hearing aid means any wearable instrument or device designed for,
offered for the purpose of, or represented as aiding persons with or
compensating for, impaired hearing.
(2) Ear specialist means any licensed physician who specializes in
diseases of the ear and is medically trained to identify the symptoms of
deafness in the context of the total health of the patient, and is
qualified by special training to diagnose and treat hearing loss. Such
physicians are also known as otolaryngologists, otologists, and
otorhinolaryngologists.
(3) Dispenser means any person, partnership, corporation, or
association engaged in the sale, lease, or rental of hearing aids to any
member of the consuming public or any employee, agent, sales person,
and/or representative of such a person, partnership, corporation, or
association.
(4) Audiologist means any person qualified by training and
experience to specialize in the evaluation and rehabilitation of
individuals whose communication disorders center in whole or in part in
the hearing function. In some states audiologists must satisfy specific
requirements for licensure.
(5) Sale or purchase includes any lease or rental of a hearing aid
to a member of the consuming public who is a user or prospective user of
a hearing aid.
[[Page 40]]
(6) Used hearing aid means any hearing aid that has been worn for
any period of time by a user. However, a hearing aid shall not be
considered ``used'' merely because it has been worn by a prospective
user as a part of a bona fide hearing aid evaluation conducted to
determine whether to select that particular hearing aid for that
prospective user, if such evaluation has been conducted in the presence
of the dispenser or a hearing aid health professional selected by the
dispenser to assist the buyer in making such a determination.
(b) Label requirements for hearing aids. Hearing aids shall be
clearly and permanently marked with:
(1) The name of the manufacturer or distributor, the model name or
number, the serial number, and the year of manufacture.
(2) A `` + '' symbol to indicate the positive connection for battery
insertion, unless it is physically impossible to insert the battery in
the reversed position.
(c) Labeling requirements for hearing aids--(1) General. All
labeling information required by this paragraph shall be included in a
User Instructional Brochure that shall be developed by the manufacturer
or distributor, shall accompany the hearing aid, and shall be provided
to the prospective user by the dispenser of the hearing aid in
accordance with Sec. 801.421(c). The User Instructional Brochure
accompanying each hearing aid shall contain the following information
and instructions for use, to the extent applicable to the particular
requirements and characteristics of the hearing aid:
(i) An illustration(s) of the hearing aid, indicating operating
controls, user adjustments, and battery compartment.
(ii) Information on the function of all controls intended for user
adjustment.
(iii) A description of any accessory that may accompany the hearing
aid, e.g., accessories for use with a television or telephone.
(iv) Specific instructions for:
(a) Use of the hearing aid.
(b) Maintenance and care of the hearing aid, including the procedure
to follow in washing the earmold, when replacing tubing on those hearing
aids that use tubing, and in storing the hearing aid when it will not be
used for an extended period of time.
(c) Replacing or recharging the batteries, including a generic
designation of replacement batteries.
(v) Information on how and where to obtain repair service, including
at least one specific address where the user can go, or send the hearing
aid to, to obtain such repair service.
(vi) A description of commonly occurring avoidable conditions that
could adversely affect or damage the hearing aid, such as dropping,
immersing, or exposing the hearing aid to excessive heat.
(vii) Identification of any known side effects associated with the
use of a hearing aid that may warrant consultation with a physician,
e.g., skin irritation and accelerated accumulation of cerumen (ear wax).
(viii) A statement that a hearing aid will not restore normal
hearing and will not prevent or improve a hearing impairment resulting
from organic conditions.
(ix) A statement that in most cases infrequent use of a hearing aid
does not permit a user to attain full benefit from it.
(x) A statement that the use of a hearing aid is only part of
hearing habilitation and may need to be supplemented by auditory
training and instruction in lipreading.
(xi) The warning statement required by paragraph (c)(2) of this
section.
(xii) The notice for prospective hearing aid users required by
paragraph (c)(3) of this section.
(xiii) The technical data required by paragraph (c)(4) of this
section, unless such data is provided in separate labeling accompanying
the device.
(2) Warning statement. The User Instructional Brochure shall contain
the following warning statement:
Warning to Hearing Aid Dispensers
A hearing aid dispenser should advise a prospective hearing aid user
to consult promptly with a licensed physician (preferably an ear
specialist) before dispensing a hearing aid if the hearing aid dispenser
determines through inquiry, actual observation, or review of any other
available information concerning the prospective user, that the
prospective user has any of the following conditions:
[[Page 41]]
(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90
days.
(iii) History of sudden or rapidly progressive hearing loss within
the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the
previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels
at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a
foreign body in the ear canal.
(viii) Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing
aid whose maximum sound pressure level exceeds 132 decibels because
there may be risk of impairing the remaining hearing of the hearing aid
user. (This provision is required only for those hearing aids with a
maximum sound pressure capability greater than 132 decibels (dB).)
(3) Notice for prospective hearing aid users. The User Instructional
Brochure shall contain the following notice:
Important Notice for Prospective Hearing Aid Users
Good health practice requires that a person with a hearing loss have
a medical evaluation by a licensed physician (preferably a physician who
specializes in diseases of the ear) before purchasing a hearing aid.
Licensed physicians who specialize in diseases of the ear are often
referred to as otolaryngologists, otologists or otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically
treatable conditions that may affect hearing are identified and treated
before the hearing aid is purchased.
Following the medical evaluation, the physician will give you a
written statement that states that your hearing loss has been medically
evaluated and that you may be considered a candidate for a hearing aid.
The physician will refer you to an audiologist or a hearing aid
dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid
evaluation to assess your ability to hear with and without a hearing
aid. The hearing aid evaluation will enable the audiologist or dispenser
to select and fit a hearing aid to your individual needs.
If you have reservations about your ability to adapt to
amplification, you should inquire about the availability of a trial-
rental or purchase-option program. Many hearing aid dispensers now offer
programs that permit you to wear a hearing aid for a period of time for
a nominal fee after which you may decide if you want to purchase the
hearing aid.
Federal law restricts the sale of hearing aids to those individuals
who have obtained a medical evaluation from a licensed physician.
Federal law permits a fully informed adult to sign a waiver statement
declining the medical evaluation for religious or personal beliefs that
preclude consultation with a physician. The exercise of such a waiver is
not in your best health interest and its use is strongly discouraged.
children with hearing loss
In addition to seeing a physician for a medical evaluation, a child
with a hearing loss should be directed to an audiologist for evaluation
and rehabilitation since hearing loss may cause problems in language
development and the educational and social growth of a child. An
audiologist is qualified by training and experience to assist in the
evaluation and rehabilitation of a child with a hearing loss.
(4) Technical data. Technical data useful in selecting, fitting, and
checking the performance of a hearing aid shall be provided in the User
Instructional Brochure or in separate labeling that accompanies the
device. The determination of technical data values for the hearing aid
labeling shall be conducted in accordance with the test procedures of
the American National Standard ``Specification of Hearing Aid
Characteristics,'' ANSI S3.22-2003 (Revision of ANSI S3.22-1996)
(Includes April 2007 Erratum). The Director of the Office of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Standards
Secretariat of the Acoustical Society of America, 120 Wall St., New
York, NY 10005-3993, or are available for inspection at the Regulations
Staff, CDRH (HFZ-215), FDA, 1350 Piccard Dr., rm. 150, Rockville, MD
20850, or at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html. As a minimum, the User
Instructional Brochure or such other labeling shall include the
appropriate values or information for the following technical data
elements as
[[Page 42]]
these elements are defined or used in such standard:
(i) Saturation output curve (SSPL 90 curve).
(ii) Frequency response curve.
(iii) Average saturation output (HF-Average SSPL 90).
(iv) Average full-on gain (HF-Average full-on gain).
(v) Reference test gain.
(vi) Frequency range.
(vii) Total harmonic distortion.
(viii) Equivalent input noise.
(ix) Battery current drain.
(x) Induction coil sensitivity (telephone coil aids only).
(xi) Input-output curve (ACG aids only).
(xii) Attack and release times (ACG aids only).
(5) Statement if hearing aid is used or rebuilt. If a hearing aid
has been used or rebuilt, this fact shall be declared on the container
in which the hearing aid is packaged and on a tag that is physically
attached to such hearing aid. Such fact may also be stated in the User
Instructional Brochure.
(6) Statements in User Instructional Brochure other than those
required. A User Instructional Brochure may contain statements or
illustrations in addition to those required by paragraph (c) of this
section if the additional statements:
(i) Are not false or misleading in any particular, e.g., diminishing
the impact of the required statements; and
(ii) Are not prohibited by this chapter or by regulations of the
Federal Trade Commission.
[42 FR 9294, Feb. 15, 1977, as amended at 47 FR 9398, Mar. 5, 1982; 50
FR 30154, July 24, 1985; 54 FR 52396, Dec. 21, 1989; 64 FR 59620, Nov.
3, 1999; 69 FR 18803, Apr. 9, 2004; 73 FR 31360, June 2, 2008]
Sec. 801.421 Hearing aid devices; conditions for sale.
(a) Medical evaluation requirements--(1) General. Except as provided
in paragraph (a)(2) of this section, a hearing aid dispenser shall not
sell a hearing aid unless the prospective user has presented to the
hearing aid dispenser a written statement signed by a licensed physician
that states that the patient's hearing loss has been medically evaluated
and the patient may be considered a candidate for a hearing aid. The
medical evaluation must have taken place within the preceding 6 months.
(2) Waiver to the medical evaluation requirements. If the
prospective hearing aid user is 18 years of age or older, the hearing
aid dispenser may afford the prospective user an opportunity to waive
the medical evaluation requirement of paragraph (a)(1) of this section
provided that the hearing aid dispenser:
(i) Informs the prospective user that the exercise of the waiver is
not in the user's best health interest;
(ii) Does not in any way actively encourage the prospective user to
waive such a medical evaluation; and
(iii) Affords the prospective user the opportunity to sign the
following statement:
I have been advised by ____ ____ (Hearing aid dispenser's name) that
the Food and Drug Administration has determined that my best health
interest would be served if I had a medical evaluation by a licensed
physician (preferably a physician who specializes in diseases of the
ear) before purchasing a hearing aid. I do not wish a medical evaluation
before purchasing a hearing aid.
(b) Opportunity to review User Instructional Brochure. Before
signing any statement under paragraph (a)(2)(iii) of this section and
before the sale of a hearing aid to a prospective user, the hearing aid
dispenser shall:
(1) Provide the prospective user a copy of the User Instructional
Brochure for a hearing aid that has been, or may be selected for the
prospective user;
(2) Review the content of the User Instructional Brochure with the
prospective user orally, or in the predominate method of communication
used during the sale;
(3) Afford the prospective user an opportunity to read the User
Instructional Brochure.
(c) Availability of User Instructional Brochure. (1) Upon request by
an individual who is considering purchase of a hearing aid, a dispenser
shall, with respect to any hearing aid that he dispenses, provide a copy
of the User Instructional Brochure for the hearing aid or the name and
address of the manufacturer or distributor from
[[Page 43]]
whom a User Instructional Brochure for the hearing aid may be obtained.
(2) In addition to assuring that a User Instructional Brochure
accompanies each hearing aid, a manufacturer or distributor shall with
respect to any hearing aid that he manufactures or distributes:
(i) Provide sufficient copies of the User Instructional Brochure to
sellers for distribution to users and prospective users;
(ii) Provide a copy of the User Instructional Brochure to any
hearing aid professional, user, or prospective user who requests a copy
in writing.
(d) Recordkeeping. The dispenser shall retain for 3 years after the
dispensing of a hearing aid a copy of any written statement from a
physician required under paragraph (a)(1) of this section or any written
statement waiving medical evaluation required under paragraph
(a)(2)(iii) of this section.
(e) Exemption for group auditory trainers. Group auditory trainers,
defined as a group amplification system purchased by a qualified school
or institution for the purpose of communicating with and educating
individuals with hearing impairments, are exempt from the requirements
of this section.
[42 FR 9296, Feb. 15, 1977]
Sec. 801.430 User labeling for menstrual tampons.
(a) This section applies to scented or scented deodorized menstrual
tampons as identified in Sec. 884.5460 and unscented menstrual tampons
as identified in Sec. 884.5470 of this chapter.
(b) Data show that toxic shock syndrome (TSS), a rare but serious
and sometimes fatal disease, is associated with the use of menstrual
tampons. To protect the public and to minimize the serious adverse
effects of TSS, menstrual tampons shall be labeled as set forth in
paragraphs (c), (d), and (e) of this section and tested for absorbency
as set forth in paragraph (f) of this section.
(c) If the information specified in paragraph (d) of this section is
to be included as a package insert, the following alert statement shall
appear prominently and legibly on the package label:
Attention: Tampons are associated with Toxic Shock Syndrome (TSS).
TSS is a rare but serious disease that may cause death. Read and save
the enclosed information.
(d) The labeling of menstrual tampons shall contain the following
consumer information prominently and legibly, in such terms as to render
the information likely to be read and understood by the ordinary
individual under customary conditions of purchase and use:
(1)(i) Warning signs of TSS, e.g., sudden fever (usually 102[deg] or
more) and vomiting, diarrhea, fainting or near fainting when standing
up, dizziness, or a rash that looks like a sunburn;
(ii) What to do if these or other signs of TSS appear, including the
need to remove the tampon at once and seek medical attention
immediately;
(2) The risk of TSS to all women using tampons during their
menstrual period, especially the reported higher risks to women under 30
years of age and teenage girls, the estimated incidence of TSS of 1 to
17 per 100,000 menstruating women and girls per year, and the risk of
death from contracting TSS;
(3) The advisability of using tampons with the minimum absorbency
needed to control menstrual flow in order to reduce the risk of
contracting TSS;
(4) Avoiding the risk of getting tampon-associated TSS by not using
tampons, and reducing the risk of getting TSS by alternating tampon use
with sanitary napkin use during menstrual periods; and
(5) The need to seek medical attention before again using tampons if
TSS warning signs have occurred in the past, or if women have any
questions about TSS or tampon use.
(e) The statements required by paragraph (e) of this section shall
be prominently and legibly placed on the package label of menstrual
tampons in conformance with section 502(c) of the Federal Food, Drug,
and Cosmetic Act (the act) (unless the menstrual tampons are exempt
under paragraph (g) of this section).
(1) Menstrual tampon package labels shall bear one of the following
absorbency terms representing the absorbency of the production run, lot,
or
[[Page 44]]
batch as measured by the test described in paragraph (f)(2) of this
section;
------------------------------------------------------------------------
Ranges of absorbency in grams \1\ Corresponding term of absorbency
------------------------------------------------------------------------
6 and under Light absorbency
------------------------------------------------------------------------
6 to 9 Regular absorbency
------------------------------------------------------------------------
9 to 12 Super absorbency
------------------------------------------------------------------------
12 to 15 Super plus absorbency
------------------------------------------------------------------------
15 to 18 Ultra absorbency
------------------------------------------------------------------------
Above 18 No term
------------------------------------------------------------------------
\1\These ranges are defined, respectively, as follows: Less than or
equal to 6 grams (g); greater than 6 g up to and including 9 g;
greater than 9 g up to and including 12 g; greater than 12 g up to and
including 15 g; greater than 15 g up to and including 18 g; and
greater than 18 g.
(2) The package label shall include an explanation of the ranges of
absorbency and a description of how consumers can use a range of
absorbency, and its corresponding absorbency term, to make comparisons
of absorbency of tampons to allow selection of the tampons with the
minimum absorbency needed to control menstrual flow in order to reduce
the risk of contracting TSS.
(f) A manufacturer shall measure the absorbency of individual
tampons using the test method specified in paragraph (f)(2) of this
section and calculate the mean absorbency of a production run, lot, or
batch by rounding to the nearest 0.1 gram.
(1) A manufacturer shall design and implement a sampling plan that
includes collection of probability samples of adequate size to yield
consistent tolerance intervals such that the probability is 90 percent
that at least 90 percent of the absorbencies of individual tampons
within a brand and type are within the range of absorbency stated on the
package label.
(2) In the absorbency test, an unlubricated condom, with tensile
strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according
to the procedure in the American Society for Testing and Materials
(ASTM) D 3492-97, ``Standard Specification for Rubber Contraceptives
(Male Condoms)'' \1\ for determining tensile strength, which is
incorporated by reference in accordance with 5 U.S.C. 552(a), is
attached to the large end of a glass chamber (or a chamber made from
hard transparent plastic) with a rubber band (see figure 1) and pushed
through the small end of the chamber using a smooth, finished rod. The
condom is pulled through until all slack is removed. The tip of the
condom is cut off and the remaining end of the condom is stretched over
the end of the tube and secured with a rubber band. A preweighed (to the
nearest 0.01 gram) tampon is placed within the condom membrane so that
the center of gravity of the tampon is at the center of the chamber. An
infusion needle (14 gauge) is inserted through the septum created by the
condom tip until it contacts the end of the tampon. The outer chamber is
filled with water pumped from a temperature-controlled waterbath to
maintain the average temperature at 271 [deg]C.
The water returns to the waterbath as shown in figure 2. Syngyna fluid
(10 grams sodium chloride, 0.5 gram Certified Reagent Acid Fushsin,
1,000 milliliters distilled water) is then pumped through the infusion
needle at a rate of 50 milliliters per hour. The test shall be
terminated when the tampon is saturated and the first drop of fluid
exits the apparatus. (The test result shall be discarded if fluid is
detected in the folds of the condom before the tampon is saturated). The
water is then drained and the tampon is removed and immediately weighed
to the nearest 0.01 gram. The absorbency of the tampon is determined by
subtracting its dry weight from this value. The condom shall be replaced
after 10 tests or at the
[[Page 45]]
end of the day during which the condom is used in testing, whichever
occurs first.
---------------------------------------------------------------------------
\1\The Director of the Federal Register approves this incorporation
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You
may obtain a copy from the American Society for Testing and Materials
International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA
19428-2959, 610-832-9578, www.astm.org. You may inspect a copy at the
FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor, Silver
Spring, MD 20993-0002, 301-796-2039, or at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, call 202-741-2139, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
[GRAPHIC] [TIFF OMITTED] TR01FE93.026
[[Page 46]]
[GRAPHIC] [TIFF OMITTED] TR01FE93.027
(3) The Food and Drug Administration may permit the use of an
absorbency test method different from the test method specified in this
section if each of the following conditions is met:
(i) The manufacturer presents evidence, in the form of a citizen
petition
[[Page 47]]
submitted in accordance with the requirements of Sec. 10.30 of this
chapter, demonstrating that the alternative test method will yield
results that are equivalent to the results yielded by the test method
specified in this section; and
(ii) FDA approves the method and has published notice of its
approval of the alternative test method in the Federal Register.
(g) Any menstrual tampon intended to be dispensed by a vending
machine is exempt from the requirements of this section.
(h) Any menstrual tampon that is not labeled as required by
paragraphs (c), (d), and (e) of this section and that is initially
introduced or initially delivered for introduction into commerce after
March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of
the act.
(Information collection requirements contained in paragraphs (e) and (f)
were approved by the Office of Management and Budget under control
number 0910-0257)
[47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989;
55 FR 17600, Apr. 26, 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July
18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR 18803, Apr. 9, 2004; 69 FR
52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010]
Sec. 801.433 Warning statements for prescription and restricted
device products containing or manufactured with chlorofluorocarbons
or other ozone-depleting substances.
(a)(1) All prescription and restricted device products containing or
manufactured with chlorofluorocarbons, halons, carbon tetrachloride,
methyl chloride, or any other class I substance designated by the
Environmental Protection Agency (EPA) shall, except as provided in
paragraph (b) of this section, bear the following warning statement:
Warning: Contains [or Manufactured with, if applicable] [insert name
of substance], a substance which harms public health and environment by
destroying ozone in the upper atmosphere.
(2) The warning statement shall be clearly legible and conspicuous
on the product, its immediate container, its outer packaging, or other
labeling in accordance with the requirements of 40 CFR part 82 and
appear with such prominence and conspicuousness as to render it likely
to be read and understood by consumers under normal conditions of
purchase.
(b)(1) For prescription and restricted device products, the
following alternative warning statement may be used:
Note: The indented statement below is required by the Federal
government's Clean Air Act for all products containing or manufactured
with chlorofluorocarbons (CFC's) [or name of other class I substance, if
applicable]:
This product contains [or is manufactured with, if applicable]
[insert name of substance], a substance which harms the environment by
destroying ozone in the upper atmosphere.
Your physician has determined that this product is likely to help
your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO
DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about
alternatives, consult with your physician.
(2) The warning statement shall be clearly legible and conspicuous
on the product, its immediate container, its outer packaging, or other
labeling in accordance with the requirements of 40 CFR part 82 and
appear with such prominence and conspicuousness as to render it likely
to be read and understood by consumers under normal conditions of
purchase.
(3) If the warning statement in paragraph (b)(1) of this section is
used, the following warning statement must be placed on the package
labeling intended to be read by the physician (physician package insert)
after the ``How supplied'' section, which describes special handling and
storage conditions on the physician labeling:
Note: The indented statement below is required by the Federal
government's Clean Air Act for all products containing or manufactured
with chlorofluorocarbons (CFC's) [or name of other class I substance, if
applicable]:
Warning: Contains [or Manufactured with, if applicable] [insert name
of substance], a substance which harms public health and environment by
destroying ozone in the upper atmosphere.
A notice similar to the above WARNING has been placed in the
information for the patient [or patient information leaflet, if
applicable] of this product under Environmental Protection Agency (EPA)
regulations. The patient's warning states that the
[[Page 48]]
patient should consult his or her physician if there are questions about
alternatives.
(c) This section does not replace or relieve a person from any
requirements imposed under 40 CFR part 82.
[61 FR 20101, May 3, 1996]
Sec. 801.435 User labeling for latex condoms.
(a) This section applies to the subset of condoms as identified in
Sec. 884.5300 of this chapter, and condoms with spermicidal lubricant
as identified in Sec. 884.5310 of this chapter, which products are
formed from latex films.
(b) Data show that the material integrity of latex condoms degrade
over time. To protect the public health and minimize the risk of device
failure, latex condoms must bear an expiration date which is supported
by testing as described in paragraphs (d) and (h) of this section.
(c) The expiration date, as demonstrated by testing procedures
required by paragraphs (d) and (h) of this section, must be displayed
prominently and legibly on the primary packaging (i.e., individual
package), and higher levels of packaging (e.g., boxes of condoms), in
order to ensure visibility of the expiration date by consumers.
(d) Except as provided under paragraph (f) of this section, the
expiration date must be supported by data demonstrating physical and
mechanical integrity of the product after three discrete and
representative lots of the product have been subjected to each of the
following conditions:
(1) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at 70 [deg]C (plus or minus 2 [deg]C)
for 7 days;
(2) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at a selected temperature between 40
and 50 [deg]C (plus or minus 2 [deg]C) for 90 days; and
(3) Storage of unpackaged bulk product for the maximum amount of
time the manufacturer allows the product to remain unpackaged, followed
by storage of the packaged product at a monitored or controlled
temperature between 15 and 30 [deg]C for the lifetime of the product
(real time storage).
(e) If a product fails the physical and mechanical integrity tests
commonly used by industry after the completion of the accelerated
storage tests described in paragraphs (d)(1) and (d)(2) of this section,
the product expiration date must be demonstrated by real time storage
conditions described in paragraph (d)(3) of this section. If all of the
products tested after storage at temperatures as described in paragraphs
(d)(1) and (d)(2) of this section pass the manufacturer's physical and
mechanical integrity tests, the manufacturer may label the product with
an expiration date of up to 5 years from the date of product packaging.
If the extrapolated expiration date under paragraphs (d)(1) and (d)(2)
of this section is used, the labeled expiration date must be confirmed
by physical and mechanical integrity tests performed at the end of the
stated expiration period as described in paragraph (d)(3) of this
section. If the data from tests following real time storage described in
paragraph (d)(3) of this section fails to confirm the extrapolated
expiration date, the manufacturer must, at that time, relabel the
product to reflect the actual shelf life.
(f) Products that already have established shelf life data based
upon real time storage and testing and have such storage and testing
data available for inspection are not required to confirm such data
using accelerated and intermediate aging data described in paragraphs
(d)(1) and (d)(2) of this section. If, however, such real time
expiration dates were based upon testing of products that were not first
left unpackaged for the maximum amount of time as described in paragraph
(d)(3) of this section, the real time testing must be confirmed by
testing products consistent with the requirements of paragraph (d)(3) of
this section. This testing shall be initiated no later than the
effective date of this regulation. Until the confirmation testing in
accordance with paragraph (d)(3) of this section is completed, the
product may remain on the market labeled with the expiration date based
upon previous real time testing.
[[Page 49]]
(g) If a manufacturer uses testing data from one product to support
expiration dating on any variation of that product, the manufacturer
must document and provide, upon request, an appropriate justification
for the application of the testing data to the variation of the tested
product.
(h) If a latex condom contains a spermicide, and the expiration date
based on spermicidal stability testing is different from the expiration
date based upon latex integrity testing, the product shall bear only the
earlier expiration date.
(i) The time period upon which the expiration date is based shall
start with the date of packaging.
(j) As provided in part 820 of this chapter, all testing data must
be retained in each company's files, and shall be made available upon
request for inspection by the Food and Drug Administration.
(k) Any latex condom not labeled with an expiration date as required
by paragraph (c) of this section, and initially delivered for
introduction into interstate commerce after the effective date of this
regulation is misbranded under sections 201(n) and 502(a) and (f) of
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and
(f)).
[62 FR 50501, Sept. 26, 1997]
Sec. 801.437 User labeling for devices that contain natural rubber.
(a) Data in the Medical Device Reporting System and the scientific
literature indicate that some individuals are at risk of severe
anaphylactic reactions to natural latex proteins. This labeling
regulation is intended to minimize the risk to individuals sensitive to
natural latex proteins and protect the public health.
(b) This section applies to all devices composed of or containing,
or having packaging or components that are composed of, or contain,
natural rubber that contacts humans. The term ``natural rubber''
includes natural rubber latex, dry natural rubber, and synthetic latex
or synthetic rubber that contains natural rubber in its formulation.
(1) The term ``natural rubber latex'' means rubber that is produced
by the natural rubber latex process that involves the use of natural
latex in a concentrated colloidal suspension. Products are formed from
natural rubber latex by dipping, extruding, or coating.
(2) The term ``dry natural rubber'' means rubber that is produced by
the dry natural rubber process that involves the use of coagulated
natural latex in the form of dried or milled sheets. Products are formed
from dry natural rubber by compression molding, extrusion, or by
converting the sheets into a solution for dipping.
(3) The term ``contacts humans'' means that the natural rubber
contained in a device is intended to contact or is likely to contact the
user or patient. This includes contact when the device that contains
natural rubber is connected to the patient by a liquid path or an
enclosed gas path; or the device containing the natural rubber is fully
or partially coated with a powder, and such powder may carry natural
rubber proteins that may contaminate the environment of the user or
patient.
(c) Devices containing natural rubber shall be labeled as set forth
in paragraphs (d) through (h) of this section. Each required labeling
statement shall be prominently and legibly displayed in conformance with
section 502(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 352(c)).
(d) Devices containing natural rubber latex that contacts humans, as
described in paragraph (b) of this section, shall bear the following
statement in bold print on the device labeling:
``Caution: This Product Contains Natural Rubber Latex Which May
Cause Allergic Reactions.''
This statement shall appear on all device labels, and other labeling,
and shall appear on the principal display panel of the device packaging,
the outside package, container or wrapper, and the immediate device
package, container, or wrapper.
(e) Devices containing dry natural rubber that contacts humans, as
described in paragraph (b) of this section, that are not already subject
to paragraph (d) of this section, shall bear the following statement in
bold print on the device labeling:
``This Product Contains Dry Natural Rubber.''
[[Page 50]]
This statement shall appear on all device labels, and other labeling,
and shall appear on the principal display panel of the device packaging,
the outside package, container or wrapper, and the immediate device
package, container, or wrapper.
(f) Devices that have packaging containing natural rubber latex that
contacts humans, as described in paragraph (b) of this section, shall
bear the following statement in bold print on the device labeling:
``Caution: The Packaging of This Product Contains Natural Rubber
Latex Which May Cause Allergic Reactions.''
This statement shall appear on the packaging that contains the natural
rubber, and the outside package, container, or wrapper.
(g) Devices that have packaging containing dry natural rubber that
contacts humans, as described in paragraph (b) of this section, shall
bear the following statement in bold print on the device labeling:
``The Packaging of This Product Contains Dry Natural Rubber.''
This statement shall appear on the packaging that contains the natural
rubber, and the outside package, container, or wrapper.
(h) Devices that contain natural rubber that contacts humans, as
described in paragraph (b) of this section, shall not contain the term
``hypoallergenic'' on their labeling.
(i) Any affected person may request an exemption or variance from
the requirements of this section by submitting a citizen petition in
accordance with Sec. 10.30 of this chapter.
(j) Any device subject to this section that is not labeled in
accordance with paragraphs (d) through (h) of this section and that is
initially introduced or initially delivered for introduction into
interstate commerce after the effective date of this regulation is
misbranded under sections 201(n) and 502(a), (c), and (f) of the act (21
U.S.C. 321(n) and 352(a), (c), and (f)).
Note to Sec. 801.437: Paragraphs (f) and (g) are stayed until June
27, 1999, as those regulations relate to device packaging that uses
``cold seal'' adhesives.
[62 FR 51029, Sept. 30, 1997, as amended at 63 FR 46175, Aug. 31, 1998]
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
Subpart A_General Provisions
Sec.
803.1 What does this part cover?
803.3 How does FDA define the terms used in this part?
803.9 What information from the reports do we disclose to the public?
803.10 Generally, what are the reporting requirements that apply to me?
803.11 What form should I use to submit reports of individual adverse
events and where do I obtain these forms?
803.12 How do I submit initial and supplemental or followup reports?
803.13 Do I need to submit reports in English?
803.15 How will I know if you require more information about my medical
device report?
803.16 When I submit a report, does the information in my report
constitute an admission that the device caused or contributed
to the reportable event?
803.17 What are the requirements for developing, maintaining, and
implementing written MDR procedures that apply to me?
803.18 What are the requirements for establishing and maintaining MDR
files or records that apply to me?
803.19 Are there exemptions, variances, or alternative forms of adverse
event reporting requirements?
Subpart B_Generally Applicable Requirements for Individual Adverse Event
Reports
803.20 How do I complete and submit an individual adverse event report?
803.21 Where can I find the reporting codes for adverse events that I
use with medical device reports?
803.22 What are the circumstances in which I am not required to file a
report?
803.23 Where can I find information on how to prepare and submit an MDR
in electronic format?
Subpart C_User Facility Reporting Requirements
803.30 If I am a user facility, what reporting requirements apply to me?
803.32 If I am a user facility, what information must I submit in my
individual adverse event reports?
[[Page 51]]
803.33 If I am a user facility, what must I include when I submit an
annual report?
Subpart D_Importer Reporting Requirements
803.40 If I am an importer, what reporting requirements apply to me?
803.42 If I am an importer, what information must I submit in my
individual adverse event reports?
Subpart E_Manufacturer Reporting Requirements
803.50 If I am a manufacturer, what reporting requirements apply to me?
803.52 If I am a manufacturer, what information must I submit in my
individual adverse event reports?
803.53 If I am a manufacturer, in which circumstances must I submit a 5-
day report?
803.56 If I am a manufacturer, in what circumstances must I submit a
supplemental or followup report and what are the requirements
for such reports?
803.58 Foreign manufacturers.
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.
Subpart A_General Provisions
Sec. 803.1 What does this part cover?
(a) This part establishes the requirements for medical device
reporting for device user facilities, manufacturers, importers, and
distributors. If you are a device user facility, you must report deaths
and serious injuries that a device has or may have caused or contributed
to, establish and maintain adverse event files, and submit summary
annual reports. If you are a manufacturer or importer, you must report
deaths and serious injuries that your device has or may have caused or
contributed to, you must report certain device malfunctions, and you
must establish and maintain adverse event files. If you are a
manufacturer, you must also submit specified followup. These reports
help us to protect the public health by helping to ensure that devices
are not adulterated or misbranded and are safe and effective for their
intended use. If you are a medical device distributor, you must maintain
records (files) of incidents, but you are not required to report these
incidents.
(b) This part supplements and does not supersede other provisions of
this chapter, including the provisions of part 820 of this chapter.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
Sec. 803.3 How does FDA define the terms used in this part?
Some of the terms we use in this part are specific to medical device
reporting and reflect the language used in the statute (law). Other
terms are more general and reflect our interpretation of the law. This
section defines the following terms as used in this part:
(a) Ambulatory surgical facility (ASF) means a distinct entity that
operates for the primary purpose of furnishing same day outpatient
surgical services to patients. An ASF may be either an independent
entity (i.e., not a part of a provider of services or any other
facility) or operated by another medical entity (e.g., under the common
ownership, licensure, or control of an entity). An ASF is subject to
this regulation regardless of whether it is licensed by a Federal,
State, municipal, or local government or regardless of whether it is
accredited by a recognized accreditation organization. If an adverse
event meets the criteria for reporting, the ASF must report that event
regardless of the nature or location of the medical service provided by
the ASF.
(b) Become aware means that an employee of the entity required to
report has acquired information that reasonably suggests a reportable
adverse event has occurred.
(1) If you are a device user facility, you are considered to have
``become aware'' when medical personnel, as defined in this section, who
are employed by or otherwise formally affiliated with your facility,
obtain information about a reportable event.
(2) If you are a manufacturer, you are considered to have become
aware of an event when any of your employees becomes aware of a
reportable event that is required to be reported within 30 calendar days
or that is required to be reported within 5 work days because we had
requested reports in accordance with Sec. 803.53(b). You are also
considered
[[Page 52]]
to have become aware of an event when any of your employees with
management or supervisory responsibilities over persons with regulatory,
scientific, or technical responsibilities, or whose duties relate to the
collection and reporting of adverse events, becomes aware, from any
information, including any trend analysis, that a reportable MDR event
or events necessitates remedial action to prevent an unreasonable risk
of substantial harm to the public health.
(3) If you are an importer, you are considered to have become aware
of an event when any of your employees becomes aware of a reportable
event that is required to be reported by you within 30 days.
(c) Caused or contributed means that a death or serious injury was
or may have been attributed to a medical device, or that a medical
device was or may have been a factor in a death or serious injury,
including events occurring as a result of:
(1) Failure,
(2) Malfunction,
(3) Improper or inadequate design,
(4) Manufacture,
(5) Labeling, or
(6) User error.
(d) Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or outpatient
treatment facility as defined in this section, which is not a
physician's office, as defined in this section. School nurse offices and
employee health units are not device user facilities.
(e) Distributor means any person (other than the manufacturer or
importer) who furthers the marketing of a device from the original place
of manufacture to the person who makes final delivery or sale to the
ultimate user, but who does not repackage or otherwise change the
container, wrapper, or labeling of the device or device package. If you
repackage or otherwise change the container, wrapper, or labeling, you
are considered a manufacturer as defined in this section.
(f) Expected life of a device means the time that a device is
expected to remain functional after it is placed into use. Certain
implanted devices have specified ``end of life'' (EOL) dates. Other
devices are not labeled as to their respective EOL, but are expected to
remain operational through activities such as maintenance, repairs, or
upgrades, for an estimated period of time.
(g) FDA, we, us, or Agency means the Food and Drug Administration.
(h) Five-day report means a medical device report that must be
submitted by a manufacturer to us under Sec. 803.53 within 5 work days.
(i) Hospital means a distinct entity that operates for the primary
purpose of providing diagnostic, therapeutic (such as medical,
occupational, speech, physical), surgical, and other patient services
for specific and general medical conditions. Hospitals include general,
chronic disease, rehabilitative, psychiatric, and other special-purpose
facilities. A hospital may be either independent (e.g., not a part of a
provider of services or any other facility) or may be operated by
another medical entity (e.g., under the common ownership, licensure, or
control of another entity). A hospital is covered by this regulation
regardless of whether it is licensed by a Federal, State, municipal or
local government or whether it is accredited by a recognized
accreditation organization. If an adverse event meets the criteria for
reporting, the hospital must report that event regardless of the nature
or location of the medical service provided by the hospital.
(j) Importer means any person who imports a device into the United
States and who furthers the marketing of a device from the original
place of manufacture to the person who makes final delivery or sale to
the ultimate user, but who does not repackage or otherwise change the
container, wrapper, or labeling of the device or device package. If you
repackage or otherwise change the container, wrapper, or labeling, you
are considered a manufacturer as defined in this section.
(k) Malfunction means the failure of a device to meet its
performance specifications or otherwise perform as intended. Performance
specifications include all claims made in the labeling for the device.
The intended performance of a device refers to the intended use for
which the device is labeled or
[[Page 53]]
marketed, as defined in Sec. 801.4 of this chapter.
(l) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedure. The term includes any person
who either:
(1) Repackages or otherwise changes the container, wrapper, or
labeling of a device in furtherance of the distribution of the device
from the original place of manufacture;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications;
(3) Manufactures components or accessories that are devices that are
ready to be used and are intended to be commercially distributed and
intended to be used as is, or are processed by a licensed practitioner
or other qualified person to meet the needs of a particular patient; or
(4) Is the U.S. agent of a foreign manufacturer.
(m) Manufacturer or importer report number. This number uniquely
identifies each individual adverse event report submitted by a
manufacturer or importer. This number consists of the following three
parts:
(1) The FDA registration number for the manufacturing site of the
reported device, or the registration number for the importer. If the
manufacturing site or the importer does not have an establishment
registration number, we will assign a temporary MDR reporting number
until the site is registered in accordance with part 807 of this
chapter. We will inform the manufacturer or importer of the temporary
MDR reporting number;
(2) The four-digit calendar year in which the report is submitted;
and
(3) The five-digit sequence number of the reports submitted during
the year, starting with 00001. (For example, the complete number will
appear as follows: 1234567-2011-00001.)
(n) MDR means medical device report.
(o) MDR reportable event (or reportable event) means:
(1) An event that user facilities become aware of that reasonably
suggests that a device has or may have caused or contributed to a death
or serious injury or
(2) An event that manufacturers or importers become aware of that
reasonably suggests that one of their marketed devices:
(i) May have caused or contributed to a death or serious injury, or
(ii) Has malfunctioned and that the device or a similar device
marketed by the manufacturer or importer would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.
(p) Medical personnel means an individual who:
(1) Is licensed, registered, or certified by a State, territory, or
other governing body, to administer health care;
(2) Has received a diploma or a degree in a professional or
scientific discipline;
(3) Is an employee responsible for receiving medical complaints or
adverse event reports; or
(4) Is a supervisor of these persons.
(q) Nursing home means:
(1) An independent entity (i.e., not a part of a provider of
services or any other facility) or one operated by another medical
entity (e.g., under the common ownership, licensure, or control of an
entity) that operates for the primary purpose of providing:
(i) Skilled nursing care and related services for persons who
require medical or nursing care;
(ii) Hospice care to the terminally ill; or
(iii) Services for the rehabilitation of the injured, disabled, or
sick.
(2) A nursing home is subject to this regulation regardless of
whether it is licensed by a Federal, State, municipal, or local
government or whether it is accredited by a recognized accreditation
organization. If an adverse event meets the criteria for reporting, the
nursing home must report that event regardless of the nature or location
of the medical service provided by the nursing home.
(r) Outpatient diagnostic facility means:
(1) A distinct entity that:
(i) Operates for the primary purpose of conducting medical
diagnostic tests on patients,
[[Page 54]]
(ii) Does not assume ongoing responsibility for patient care, and
(iii) Provides its services for use by other medical personnel.
(2) Outpatient diagnostic facilities include outpatient facilities
providing radiography, mammography, ultrasonography,
electrocardiography, magnetic resonance imaging, computerized axial
tomography, and in vitro testing. An outpatient diagnostic facility may
be either independent (i.e., not a part of a provider of services or any
other facility) or operated by another medical entity (e.g., under the
common ownership, licensure, or control of an entity). An outpatient
diagnostic facility is covered by this regulation regardless of whether
it is licensed by a Federal, State, municipal, or local government or
whether it is accredited by a recognized accreditation organization. If
an adverse event meets the criteria for reporting, the outpatient
diagnostic facility must report that event regardless of the nature or
location of the medical service provided by the outpatient diagnostic
facility.
(s) Outpatient treatment facility means a distinct entity that
operates for the primary purpose of providing nonsurgical therapeutic
(medical, occupational, or physical) care on an outpatient basis or in a
home health care setting. Outpatient treatment facilities include
ambulance providers, rescue services, and home health care groups.
Examples of services provided by outpatient treatment facilities include
the following: Cardiac defibrillation, chemotherapy, radiotherapy, pain
control, dialysis, speech or physical therapy, and treatment for
substance abuse. An outpatient treatment facility may be either
independent (i.e., not a part of a provider of services or any other
facility) or operated by another medical entity (e.g., under the common
ownership, licensure, or control of an entity). An outpatient treatment
facility is covered by this regulation regardless of whether it is
licensed by a Federal, State, municipal, or local government or whether
it is accredited by a recognized accreditation organization. If an
adverse event meets the criteria for reporting, the outpatient treatment
facility must report that event regardless of the nature or location of
the medical service provided by the outpatient treatment facility.
(t) Patient of the facility means any individual who is being
diagnosed or treated and/or receiving medical care at or under the
control or authority of the facility. This includes employees of the
facility or individuals affiliated with the facility who, in the course
of their duties, suffer a device-related death or serious injury that
has or may have been caused or contributed to by a device used at the
facility.
(u) Physician's office means a facility that operates as the office
of a physician or other health care professional for the primary purpose
of examination, evaluation, and treatment or referral of patients.
Examples of physician offices include: Dentist offices, chiropractor
offices, optometrist offices, nurse practitioner offices, school nurse
offices, school clinics, employee health clinics, or freestanding care
units. A physician's office may be independent, a group practice, or
part of a Health Maintenance Organization.
(v) Remedial action means any action other than routine maintenance
or servicing of a device where such action is necessary to prevent
recurrence of a reportable event.
(w) Serious injury means an injury or illness that:
(1) Is life-threatening,
(2) Results in permanent impairment of a body function or permanent
damage to a body structure, or
(3) Necessitates medical or surgical intervention to preclude
permanent impairment of a body function or permanent damage to a body
structure. Permanent means irreversible impairment or damage to a body
structure or function, excluding trivial impairment or damage.
(x) User facility report number means the number that uniquely
identifies each report submitted by a user facility to manufacturers and
to us. This number consists of the following three parts:
(1) The user facility's 10-digit Centers for Medicare and Medicaid
Services (CMS) number (if the CMS number has fewer than 10 digits, fill
the remaining spaces with zeros);
[[Page 55]]
(2) The four-digit calendar year in which the report is submitted;
and
(3) The four-digit sequence number of the reports submitted for the
year, starting with 0001. (For example, a complete user facility report
number will appear as follows: 1234560000-2011-0001. If a user facility
has more than one CMS number, it must select one that will be used for
all of its MDR reports. If a user facility has no CMS number, it should
use all zeros in the appropriate space in its initial report (e.g.,
0000000000-2011-0001). We will assign a number for future use and send
that number to the user facility. This number is used in our record of
the initial report, in subsequent reports, and in any correspondence
with the user facility. If a facility has multiple sites, the primary
site may submit reports for all sites and use one reporting number for
all sites if the primary site provides the name, address, and CMS number
for each respective site.)
(y) Work day means Monday through Friday, except Federal holidays.
(z) [Reserved]
(aa) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of
this chapter that does not meet the criteria in Sec. 1271.10(a) and
that is also regulated as a device.
(bb) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec. 830.20 of this chapter. A unique
device identifier is composed of:
(1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
(2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.
(v) For an HCT/P regulated as a device, the distinct identification
code required by Sec. 1271.290(c) of this chapter.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
Sec. 803.9 What information from the reports do we disclose to the public?
(a) We may disclose to the public any report, including any FDA
record of a telephone report, submitted under this part. Our disclosures
are governed by part 20 of this chapter.
(b) Before we disclose a report to the public, we will delete the
following:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
(2) Any personal, medical, and similar information, including the
serial number of implanted devices, which would constitute an invasion
of personal privacy under Sec. 20.63 of this chapter. However, if a
patient requests a report, we will disclose to that patient all the
information in the report concerning that patient, as provided in Sec.
20.61 of this chapter; and
(3) Any names and other identifying information of a third party
that voluntarily submitted an adverse event report.
(c) We may not disclose the identity of a device user facility that
makes a report under this part except in connection with:
(1) An action brought to enforce section 301(q) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or
refusal to furnish material or information required by section 519 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i));
(2) A communication to a manufacturer of a device that is the
subject of a report required to be submitted by a user facility under
Sec. 803.30; or
(3) A disclosure to employees of the Department of Health and Human
Services, to the Department of Justice, or to the duly authorized
committees and subcommittees of the Congress.
[[Page 56]]
Sec. 803.10 Generally, what are the reporting requirements that apply to me?
(a) If you are a device user facility, you must submit reports
(described in subpart C of this part), as follows:
(1) Submit reports of individual adverse events no later than 10
work days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths to us and to the
manufacturer, if known, or
(ii) Submit reports of device-related serious injuries to the
manufacturers or, if the manufacturer is unknown, submit reports to us.
(2) Submit annual reports (described in Sec. 803.33) to us.
(b) If you are an importer, you must submit reports (described in
subpart D of this part), as follows:
(1) Submit reports of individual adverse events no later than 30
calendar days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths or serious injuries to
us and to the manufacturer or
(ii) Submit reports of device-related malfunctions to the
manufacturer.
(2) [Reserved]
(c) If you are a manufacturer, you must submit reports (described in
subpart E of this part) to us, as follows:
(1) Submit reports of individual adverse events no later than 30
calendar days after the day that you become aware of a reportable death,
serious injury, or malfunction.
(2) Submit reports of individual adverse events no later than 5 work
days after the day that you become aware of:
(i) A reportable event that requires remedial action to prevent an
unreasonable risk of substantial harm to the public health or
(ii) A reportable event for which we made a written request.
(3) Submit supplemental reports if you obtain information that you
did not submit in an initial report.
Sec. 803.11 What form should I use to submit reports of individual
adverse events and where do I obtain these forms?
(a) If you are a manufacturer or importer, you must submit reports
of individual adverse events to FDA in an electronic format in
accordance with Sec. 803.12(a) and Sec. 803.20, unless granted an
exemption under Sec. 803.19.
(b) Importer reports submitted to device manufacturers may be in
paper format or an electronic format that includes all required data
fields to ensure that the manufacturer has all required information.
(c) If you are a user facility, you must submit reports of
individual adverse events in accordance with Sec. 803.12(b) and Sec.
803.20.
(d) Form FDA 3500A is available on the Internet at http://
www.fda.gov/medwatch/getforms.htm or from Division of International and
Consumer Education, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621,
Silver Spring, MD 20993-0002, by email: [email protected], FAX: 301-847-
8149, or telephone: 800-638-2041.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
Sec. 803.12 How do I submit initial and supplemental or followup reports?
(a) Manufacturers and importers must submit initial and supplemental
or followup reports to FDA in an electronic format that FDA can process,
review, and archive.
(b) User facilities that submit their reports and additional
information to FDA electronically must use an electronic format that FDA
can process, review, and archive. User facilities that submit their
reports to FDA on paper must submit any written report or additional
information required under this part to FDA, CDRH, Medical Device
Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA
3500A. Each report must be identified (e.g., ``User Facility Report'' or
``Annual Report'').
(c) If you are confronted with a public health emergency, this can
be
[[Page 57]]
brought to FDA's attention by contacting FDA's Office of Crisis
Management, Emergency Operations Center by telephone, 24-hours a day, at
301-796-8240 or toll free at 866-300-4374, followed by the submission of
an email to: [email protected].
Note: This action does not satisfy your obligation to report under
part 803.
(d) You may submit a voluntary telephone report to the MedWatch
office at 800-FDA-1088. You may also obtain information regarding
voluntary reporting from the MedWatch office at 800-FDA-1088. You may
also find the voluntary Form FDA 3500 and instructions to complete it
at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/
default.htm.
Sec. 803.13 Do I need to submit reports in English?
Yes. You must submit all reports required by this part in English.
Sec. 803.15 How will I know if you require more information about
my medical device report?
(a) We will notify you in writing if we require additional
information and will tell you what information we need. We will require
additional information if we determine that protection of the public
health requires additional or clarifying information for medical device
reports submitted to us and in cases when the additional information is
beyond the scope of FDA reporting forms or is not readily accessible to
us.
(b) In any request under this section, we will state the reason or
purpose for the information request, specify the due date for submitting
the information, and clearly identify the reported event(s) related to
our request. If we verbally request additional information, we will
confirm the request in writing.
Sec. 803.16 When I submit a report, does the information in my report
constitute an admission that the device caused or contributed
to the reportable event?
No. A report or other information submitted by you, and our release
of that report or information, is not necessarily an admission that the
device, or you or your employees, caused or contributed to the
reportable event. You do not have to admit and may deny that the report
or information submitted under this part constitutes an admission that
the device, you, or your employees, caused or contributed to a
reportable event.
Sec. 803.17 What are the requirements for developing, maintaining,
and implementing written MDR procedures that apply to me?
If you are a user facility, importer, or manufacturer, you must
develop, maintain, and implement written MDR procedures for the
following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and
evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when
an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to
manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was
reportable;
(2) All medical device reports and information submitted to
manufacturers and/or us;
(3) Any information that was evaluated for the purpose of preparing
the submission of annual reports; and
(4) Systems that ensure access to information that facilitates
timely followup and inspection by us.
Sec. 803.18 What are the requirements for establishing and maintaining
MDR files or records that apply to me?
(a) If you are a user facility, importer, or manufacturer, you must
establish and maintain MDR event files. You must clearly identify all
MDR event files and maintain them to facilitate timely access.
(b)(1) For purposes of this part, ``MDR event files'' are written or
electronic files maintained by user facilities, importers, and
manufacturers. MDR event files may incorporate references to other
information (e.g., medical records, patient files, engineering reports),
in lieu of copying and maintaining duplicates in this file. Your MDR
event files must contain:
[[Page 58]]
(i) Information in your possession or references to information
related to the adverse event, including all documentation of your
deliberations and decision making processes used to determine if a
device-related death, serious injury, or malfunction was or was not
reportable under this part;
(ii) Copies of all reports submitted under this part (whether paper
or electronic), and of all other information related to the event that
you submitted to us or other entities such as an importer, distributor,
or manufacturer; and
(iii) Copies of all electronic acknowledgments FDA sends you in
response to electronic MDR submissions.
(2) If you are a user facility, importer, or manufacturer, you must
permit any authorized FDA employee, at all reasonable times, to access,
to copy, and to verify the records required by this part.
(c) If you are a user facility, you must retain an MDR event file
relating to an adverse event for a period of 2 years from the date of
the event. If you are a manufacturer or importer, you must retain an MDR
event file relating to an adverse event for a period of 2 years from the
date of the event or a period of time equivalent to the expected life of
the device, whichever is greater. If the device is no longer
distributed, you still must maintain MDR event files for the time
periods described in this paragraph (c).
(d)(1) If you are a device distributor, you must establish and
maintain device complaint records (files). Your records must contain any
incident information, including any written, electronic, or oral
communication, either received or generated by you, that alleges
deficiencies related to the identity (e.g., labeling), quality,
durability, reliability, safety, effectiveness, or performance of a
device. You must also maintain information about your evaluation of the
allegations, if any, in the incident record. You must clearly identify
the records as device incident records and file these records by device
name. You may maintain these records in written or electronic format.
You must back up any file maintained in electronic format.
(2) You must retain copies of the required device incident records
for a period of 2 years from the date of inclusion of the record in the
file or for a period of time equivalent to the expected life of the
device, whichever is greater. You must maintain copies of these records
for this period even if you no longer distribute the device.
(3) You must maintain the device complaint files established under
this section at your principal business establishment. If you are also a
manufacturer, you may maintain the file at the same location as you
maintain your complaint file under part 820 of this chapter. You must
permit any authorized FDA employee, at all reasonable times, to access,
to copy, and to verify the records required by this part.
(e) If you are a manufacturer, you may maintain MDR event files as
part of your complaint file, under part 820 of this chapter, if you
prominently identify these records as MDR reportable events. We will not
consider your submitted MDR report to comply with this part unless you
evaluate an event in accordance with the quality system requirements
described in part 820 of this chapter. You must document and maintain in
your MDR event files an explanation of why you did not submit or could
not obtain any information required by this part, as well as the results
of your evaluation of each event.
Sec. 803.19 Are there exemptions, variances, or alternative forms
of adverse event reporting requirements?
(a) We exempt the following persons from the adverse event reporting
requirements in this part:
(1) A licensed practitioner who prescribes or administers devices
intended for use in humans and manufactures or imports devices solely
for use in diagnosing and treating persons with whom the practitioner
has a ``physician-patient'' relationship;
(2) An individual who manufactures devices intended for use in
humans solely for this person's use in research or teaching and not for
sale. This includes any person who is subject to alternative reporting
requirements under the investigational device exemption regulations
(described in part 812 of
[[Page 59]]
this chapter), which require reporting of all adverse device effects;
and
(3) Dental laboratories or optical laboratories.
(b) If you are a manufacturer, importer, or user facility, you may
request an exemption or variance from any or all of the reporting
requirements in this part, including the requirements of Sec. 803.12.
You must submit the request to us in writing at the following address:
MDR Exemption Requests, Office of Surveillance and Biometrics, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3217, Silver Spring, MD 20993-0002. Your
request must include information necessary to identify you and the
device; a complete statement of the request for exemption, variance, or
alternative reporting; and an explanation why your request is justified.
If you are requesting an exemption from the requirement to submit
reports to FDA in electronic format under Sec. 803.12(a), your request
should indicate for how long you will require this exemption.
(c) If you are a manufacturer, importer, or user facility, we may
grant in writing an exemption or variance from, or alternative to, any
or all of the reporting requirements in this part, and may change the
frequency of reporting to quarterly, semiannually, annually or other
appropriate time period. We may grant these modifications in response to
your request, as described in paragraph (b) of this section, or at our
discretion. When we grant modifications to the reporting requirements,
we may impose other reporting requirements to ensure the protection of
public health.
(d) We may revoke or modify in writing an exemption, variance, or
alternative reporting requirement if we determine that revocation or
modification is necessary to protect the public health.
(e) If we grant your request for a reporting modification, you must
submit any reports or information required in our approval of the
modification. The conditions of the approval will replace and supersede
the regular reporting requirement specified in this part until such time
that we revoke or modify the alternative reporting requirements in
accordance with paragraph (d) of this section or until the date
specified in our response granting your variance, at which time the
provisions of this part will again apply.
Subpart B_Generally Applicable Requirements for Individual Adverse Event
Reports
Sec. 803.20 How do I complete and submit an individual adverse event report?
(a) What form must I complete and submit?
(1) If you are a health professional or consumer or other entity,
you may submit voluntary reports to FDA regarding devices or other FDA-
regulated products using the Form FDA 3500.
(2) To submit a mandatory report in written form, a user facility
must use Form FDA 3500A.
(3) An electronic submission of a mandatory report from a user
facility, importer, or manufacturer must contain the information from
the applicable blocks of Form FDA 3500A. All electronic submissions must
include information about the patient, the event, the device, and the
``initial reporter.'' An electronic submission from a user facility or
importer must include the information from block F. An electronic
submission from a manufacturer must include the information from blocks
G and H. If you are a manufacturer and you receive a report from a user
facility or importer, you must incorporate that information in your
electronic submission and include any corrected or missing information.
(b) To whom must I submit reports and when?
(1) If you are a user facility, you must submit MDR reports to:
(i) The manufacturer and to us no later than 10 work days after the
day that you become aware of information that reasonably suggests that a
device has or may have caused or contributed to a death or
(ii) The manufacturer no later than 10 work days after the day that
you become aware of information that reasonably suggests that a device
has or may have caused or contributed to a serious injury. If the
manufacturer is not known, you must submit this report to us.
[[Page 60]]
(2) If you are an importer, you must submit MDR reports to:
(i) The manufacturer and to us, no later than 30 calendar days after
the day that you become aware of information that reasonably suggests
that a device has or may have caused or contributed to a death or
serious injury or
(ii) The manufacturer, no later than 30 calendar days after
receiving information that a device you market has malfunctioned and
that this device or a similar device that you market would be likely to
cause or contribute to a death or serious injury if the malfunction were
to recur.
(3) If you are a manufacturer, you must submit MDR reports to us:
(i) No later than 30 calendar days after the day that you become
aware of information that reasonably suggests that a device may have
caused or contributed to a death or serious injury or
(ii) No later than 30 calendar days after the day that you become
aware of information that reasonably suggests a device has malfunctioned
and that this device or a similar device that you market would be likely
to cause or contribute to a death or serious injury if the malfunction
were to recur; or
(iii) Within 5 work days if required by Sec. 803.53.
(c) What kind of information reasonably suggests that a reportable
event has occurred?
(1) Any information, including professional, scientific, or medical
facts, observations, or opinions, may reasonably suggest that a device
has caused or may have caused or contributed to an MDR reportable event.
An MDR reportable event is a death, a serious injury, or, if you are a
manufacturer or importer, a malfunction that would be likely to cause or
contribute to a death or serious injury if the malfunction were to
recur.
(2) If you are a user facility, importer, or manufacturer, you do
not have to report an adverse event if you have information that would
lead a person who is qualified to make a medical judgment reasonably to
conclude that a device did not cause or contribute to a death or serious
injury, or that a malfunction would not be likely to cause or contribute
to a death or serious injury if it were to recur. Persons qualified to
make a medical judgment include physicians, nurses, risk managers, and
biomedical engineers. You must keep in your MDR event files (described
in Sec. 803.18) the information that the qualified person used to
determine whether or not a device-related event was reportable.
Sec. 803.21 Where can I find the reporting codes for adverse events
that I use with medical device reports?
(a) The MedWatch Medical Device Reporting Code Instruction Manual
contains adverse event codes for use with Form FDA 3500A. You may obtain
the coding manual from FDA's Web site at: http://www.fda.gov/
MedicalDevices/Safety/ReportaProblem/FormsandInstructions/default.htm;
and from the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, FAX:
301-847-8149, or email to [email protected].
(b) We may sometimes use additional coding of information on the
reporting forms or modify the existing codes. If we do make
modifications, we will ensure that we make the new coding information
available to all reporters.
Sec. 803.22 What are the circumstances in which I am not required
to file a report?
(a) If you become aware of information from multiple sources
regarding the same patient and same reportable event, you may submit one
medical device report.
(b) You are not required to submit a medical device report if:
(1) You are a user facility, importer, or manufacturer, and you
determine that the information received is erroneous in that a device-
related adverse event did not occur. You must retain documentation of
these reports in your MDR files for the time periods specified in Sec.
803.18.
(2) You are a manufacturer or importer and you did not manufacture
or import the device about which you have adverse event information.
When
[[Page 61]]
you receive reportable event information in error, you must forward this
information to us with a cover letter explaining that you did not
manufacture or import the device in question.
Sec. 803.23 Where can I find information on how to prepare and submit
an MDR in electronic format?
(a) You may obtain information on how to prepare and submit reports
in an electronic format that FDA can process, review, and archive at:
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
(b) We may sometimes update information on how to prepare and submit
reports electronically. If we do make modifications, we will ensure that
we alert reporters by updating the eMDR Web page.
Subpart C_User Facility Reporting Requirements
Sec. 803.30 If I am a user facility, what reporting requirements apply to me?
(a) You must submit reports to the manufacturer or to us, or both,
as specified in paragraphs (a)(1) and (a)(2) of this section as follows:
(1) Reports of death. You must submit a report to us as soon as
practicable but no more than 10 work days after the day that you become
aware of information, from any source, that reasonably suggests that a
device has or may have caused or contributed to the death of a patient
of your facility. You must also submit the report to the device
manufacturer, if known. You must submit the information required by
Sec. 803.32. Reports sent to the Agency must be submitted in accordance
with the requirements of Sec. 803.12(b).
(2) Reports of serious injury. You must submit a report to the
manufacturer of the device no later than 10 work days after the day that
you become aware of information, from any source, that reasonably
suggests that a device has or may have caused or contributed to a
serious injury to a patient of your facility. If the manufacturer is not
known, you must submit the report to us. You must report information
required by Sec. 803.32. Reports sent to the Agency must be submitted
in accordance with the requirements of Sec. 803.12 (b).
(b) What information does FDA consider ``reasonably known'' to me?
You must submit all information required in this subpart C that is
reasonably known to you. This information includes information found in
documents that you possess and any information that becomes available as
a result of reasonable followup within your facility. You are not
required to evaluate or investigate the event by obtaining or evaluating
information that you do not reasonably know.
Sec. 803.32 If I am a user facility, what information must I submit
in my individual adverse event reports?
You must include the following information in your report, if
reasonably known to you, as described in Sec. 803.30(b). These types of
information correspond generally to the elements of Form FDA 3500A:
(a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event (e.g., death or serious
injury). An outcome is considered a serious injury if it is:
(i) A life-threatening injury or illness;
(ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
(iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of this report;
[[Page 62]]
(5) Description of event or problem, including a discussion of how
the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Description of other relevant history, including preexisting
medical conditions.
(c) Device information (Form FDA 3500A, Block D). You must submit
the following:
(1) Brand name;
(2) Product Code, if known, and Common Device Name;
(3) Manufacturer name, city, and state;
(4) Model number, catalog number, serial number, lot number, or
other identifying number; expiration date; and unique device identifier
(UDI) that appears on the device label or on the device package;
(5) Operator of the device (health professional, lay user/patient,
other);
(6) Date of device implantation (month, day, year), if applicable;
(7) Date of device explantation (month, day, year), if applicable;
(8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
(9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
(10) Whether the device was available for evaluation and whether the
device was returned to the manufacturer; if so, the date it was returned
to the manufacturer; and
(11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
(d) Initial reporter information (Form FDA 3500A, Block E). You must
submit the following:
(1) Name, address, and telephone number of the reporter who
initially provided information to you, or to the manufacturer or
distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
us, if known.
(e) User facility information (Form FDA 3500A, Block F). You must
submit the following:
(1) An indication that this is a user facility report (by marking
the user facility box on the form);
(2) Your user facility number;
(3) Your address;
(4) Your contact person;
(5) Your contact person's telephone number;
(6) Date that you became aware of the event (month, day, year);
(7) Type of report (initial or followup); if it is a followup, you
must include the report number of the initial report;
(8) Date of your report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes--patient code and device code (refer to the
``MedWatch Medical Device Reporting Code Instructions'');
(11) Whether a report was sent to us and the date it was sent
(month, day, year);
(12) Location where the event occurred;
(13) Whether the report was sent to the manufacturer and the date it
was sent (month, day, year); and
(14) Manufacturer name and address, if available.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
Sec. 803.33 If I am a user facility, what must I include when I submit
an annual report?
(a) You must submit to us an annual report on Form FDA 3419. You
must submit an annual report by January 1, of each year. You may obtain
this form from the following sources:
(1) On the Internet at: http://www.fda.gov/downloads/AboutFDA/
ReportsManualsForms/Forms/UCM080796.pdf or
(2) Division of International and Consumer Education, Center for
Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by
email:
[[Page 63]]
[email protected], FAX: 301-847-8149, or telephone: 800-638-2041.
(b) You must clearly identify your annual report as such. You must
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O.
Box 3002, Rockville, MD 20847-3002. Your annual report must include:
(1) Your CMS provider number used for medical device reports, or the
number assigned by us for reporting purposes in accordance with Sec.
803.3;
(2) Reporting year;
(3) Your name and complete address;
(4) Total number of reports attached or summarized;
(5) Date of the annual report and report numbers identifying the
range of medical device reports that you submitted during the report
period (e.g., 1234567890-2011-0001 through 1000);
(6) Name, position title, and complete address of the individual
designated as your contact person responsible for reporting to us and
whether that person is a new contact for you; and
(7) Information for each reportable event that occurred during the
annual reporting period including:
(i) Report number;
(ii) Name and address of the device manufacturer;
(iii) Device brand name and common name;
(iv) Product model, catalog, serial, and lot number and unique
device identifier (UDI) that appears on the device label or on the
device package;
(v) A brief description of the event reported to the manufacturer
and/or us; and
(vi) Where the report was submitted, i.e., to the manufacturer,
importer, or us.
(c) In lieu of submitting the information in paragraph (b)(7) of
this section, you may submit a copy of each medical device report that
you submitted to the manufacturers and/or to us during the reporting
period.
(d) If you did not submit any medical device reports to
manufacturers or us during the time period, you do not need to submit an
annual report.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
Subpart D_Importer Reporting Requirements
Sec. 803.40 If I am an importer, what reporting requirements apply to me?
(a) Reports of deaths or serious injuries. You must submit a report
to us, and a copy of this report to the manufacturer, as soon as
practicable, but no later than 30 calendar days after the day that you
receive or otherwise become aware of information from any source,
including user facilities, individuals, or medical or scientific
literature, whether published or unpublished, that reasonably suggests
that one of your marketed devices may have caused or contributed to a
death or serious injury. You must submit the information required by
Sec. 803.42. Reports sent to the Agency must be submitted in accordance
with the requirements of Sec. 803.12(a).
(b) Reports of malfunctions. You must submit a report to the
manufacturer as soon as practicable but no later than 30 calendar days
after the day that you receive or otherwise become aware of information
from any source, including user facilities, individuals, or through your
own research, testing, evaluation, servicing, or maintenance of one of
your devices, that reasonably suggests that one of your devices has
malfunctioned and that this device or a similar device that you market
would be likely to cause or contribute to a death or serious injury if
the malfunction were to recur. You must submit the information required
by Sec. 803.42. Reports to manufacturers may be made in accordance with
Sec. 803.11(b).
Sec. 803.42 If I am an importer, what information must I submit
in my individual adverse event reports?
You must include the following information in your report, if the
information is known or should be known to you, as described in Sec.
803.40. These types of information correspond generally to the format of
Form FDA 3500A:
(a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
[[Page 64]]
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event (e.g., death or serious
injury). An outcome is considered a serious injury if it is:
(i) A life-threatening injury or illness;
(ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
(iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of this report;
(5) Description of the event or problem, including a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Description of other relevant patient history, including
preexisting medical conditions.
(c) Device information (Form FDA 3500A, Block D). You must submit
the following:
(1) Brand name;
(2) Product Code, if known, and Common Device Name;
(3) Manufacturer name, city, and state;
(4) Model number, catalog number, serial number, lot number, or
other identifying number; expiration date; and unique device identifier
(UDI) that appears on the device label or on the device package;
(5) Operator of the device (health professional, lay user/patient,
other);
(6) Date of device implantation (month, day, year), if applicable;
(7) Date of device explanation (month, day, year), if applicable;
(8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
(9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
(10) Whether the device was available for evaluation, and whether
the device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
(11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
(d) Initial reporter information (Form FDA 3500A, Block E). You must
submit the following:
(1) Name, address, and telephone number of the reporter who
initially provided information to the manufacturer, user facility, or
distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
us, if known.
(e) Importer information (Form FDA 3500A, Block F). You must submit
the following:
(1) An indication that this is an importer report (by marking the
importer box on the form);
(2) Your importer report number;
(3) Your address;
(4) Your contact person;
(5) Your contact person's telephone number;
(6) Date that you became aware of the event (month, day, year);
(7) Type of report (initial or followup). If it is a followup
report, you must include the report number of your initial report;
(8) Date of your report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes--patient code and device code (refer to FDA
MedWatch Medical Device Reporting Code Instructions);
(11) Whether a report was sent to us and the date it was sent
(month, day, year);
(12) Location where event occurred;
(13) Whether a report was sent to the manufacturer and the date it
was sent (month, day, year); and
[[Page 65]]
(14) Manufacturer name and address, if available.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
Subpart E_Manufacturer Reporting Requirements
Sec. 803.50 If I am a manufacturer, what reporting requirements apply to me?
(a) If you are a manufacturer, you must report to us the information
required by Sec. 803.52 in accordance with the requirements of Sec.
803.12(a), no later than 30 calendar days after the day that you receive
or otherwise become aware of information, from any source, that
reasonably suggests that a device that you market:
(1) May have caused or contributed to a death or serious injury or
(2) Has malfunctioned and this device or a similar device that you
market would be likely to cause or contribute to a death or serious
injury, if the malfunction were to recur.
(b) What information does FDA consider ``reasonably known'' to me?
(1) You must submit all information required in this subpart E that
is reasonably known to you. We consider the following information to be
reasonably known to you:
(i) Any information that you can obtain by contacting a user
facility, importer, or other initial reporter;
(ii) Any information in your possession; or
(iii) Any information that you can obtain by analysis, testing, or
other evaluation of the device.
(2) You are responsible for obtaining and submitting to us
information that is incomplete or missing from reports submitted by user
facilities, importers, and other initial reporters.
(3) You are also responsible for conducting an investigation of each
event and evaluating the cause of the event. If you cannot submit
complete information on a report, you must provide a statement
explaining why this information was incomplete and the steps you took to
obtain the information. If you later obtain any required information
that was not available at the time you filed your initial report, you
must submit this information in a supplemental report under Sec. 803.56
in accordance with the requirements of Sec. 803.12(a).
Sec. 803.52 If I am a manufacturer, what information must I submit
in my individual adverse event reports?
You must include the following information in your reports, if known
or reasonably known to you, as described in Sec. 803.50(b). These types
of information correspond generally to the format of Form FDA 3500A:
(a) Patient information (Form FDA 3500A, Block A). You must submit
the following:
(1) Patient name or other identifier;
(2) Patient age at the time of event, or date of birth;
(3) Patient gender; and
(4) Patient weight.
(b) Adverse event or product problem (Form FDA 3500A, Block B). You
must submit the following:
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event (e.g., death or serious
injury). An outcome is considered a serious injury if it is:
(i) A life-threatening injury or illness;
(ii) A disability resulting in permanent impairment of a body
function or permanent damage to a body structure; or
(iii) An injury or illness that requires intervention to prevent
permanent impairment of a body structure or function;
(3) Date of event;
(4) Date of this report;
(5) Description of the event or problem, including a discussion of
how the device was involved, nature of the problem, patient followup or
required treatment, and any environmental conditions that may have
influenced the event;
(6) Description of relevant tests, including dates and laboratory
data; and
(7) Other relevant patient history including preexisting medical
conditions.
(c) Device information (Form FDA 3500A, Block D). You must submit
the following:
(1) Brand name;
(2) Product Code, if known, and Common Device Name;
[[Page 66]]
(3) Manufacturer name, city, and state;
(4) Model number, catalog number, serial number, lot number, or
other identifying number; expiration date; and unique device identifier
(UDI) that appears on the device label or on the device package;
(5) Operator of the device (health professional, lay user/patient,
other);
(6) Date of device implantation (month, day, year), if applicable;
(7) Date of device explantation (month, day, year), if applicable;
(8) Whether the device is a single-use device that was reprocessed
and reused on a patient (Yes, No)?
(9) If the device is a single-use device that was reprocessed and
reused on a patient (yes to paragraph (c)(8) of this section), the name
and address of the reprocessor;
(10) Whether the device was available for evaluation, and whether
the device was returned to the manufacturer, and if so, the date it was
returned to the manufacturer; and
(11) Concomitant medical products and therapy dates. (Do not report
products that were used to treat the event.)
(d) Initial reporter information (Form FDA 3500A, Block E). You must
submit the following:
(1) Name, address, and telephone number of the reporter who
initially provided information to you, or to the user facility or
importer;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to
us, if known.
(e) Reporting information for all manufacturers (Form FDA 3500A,
Block G). You must submit the following:
(1) Your reporting office's contact name and address and device
manufacturing site;
(2) Your contact person's telephone number;
(3) Your report sources;
(4) Date received by you (month, day, year);
(5) PMA/510k Number and whether or not the product is a combination
product;
(6) Type of report being submitted (e.g., 5-day, initial, followup);
and
(7) Your report number.
(f) Device manufacturer information (Form FDA 3500A, Block H). You
must submit the following:
(1) Type of reportable event (death, serious injury, malfunction,
etc.);
(2) Type of followup report, if applicable (e.g., correction,
response to FDA request, etc);
(3) If the device was returned to you and evaluated by you, you must
include a summary of the evaluation. If you did not perform an
evaluation, you must explain why you did not perform an evaluation;
(4) Device manufacture date (month, day, year);
(5) Whether the device was labeled for single use;
(6) Evaluation codes (including event codes, method of evaluation,
result, and conclusion codes) (refer to FDA MedWatch Medical Device
Reporting Code Instructions);
(7) Whether remedial action was taken and the type of action;
(8) Whether the use of the device was initial, reuse, or unknown;
(9) Whether remedial action was reported as a removal or correction
under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and if
it was, provide the correction/removal report number; and
(10) Your additional narrative; and/or
(11) Corrected data, including:
(i) Any information missing on the user facility report or importer
report, including any event codes that were not reported, or information
corrected on these forms after your verification;
(ii) For each event code provided by the user facility under Sec.
803.32(e)(10) or the importer under Sec. 803.42(e)(10), you must
include a statement of whether the type of the event represented by the
code is addressed in the device labeling; and
(iii) If your report omits any required information, you must
explain why this information was not provided and the steps taken to
obtain this information.
[79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015]
[[Page 67]]
Sec. 803.53 If I am a manufacturer, in which circumstances must I submit
a 5-day report?
You must submit a 5-day report to us with the information required
by Sec. 803.52 in accordance with the requirements of Sec. 803.12(a)
no later than 5 work days after the day that you become aware that:
(a) An MDR reportable event necessitates remedial action to prevent
an unreasonable risk of substantial harm to the public health. You may
become aware of the need for remedial action from any information,
including any trend analysis or
(b) We have made a written request for the submission of a 5-day
report. If you receive such a written request from us, you must submit,
without further requests, a 5-day report for all subsequent events of
the same nature that involve substantially similar devices for the time
period specified in the written request. We may extend the time period
stated in the original written request if we determine it is in the
interest of the public health.
Sec. 803.56 If I am a manufacturer, in what circumstances must I submit
a supplemental or followup report and what are the requirements
for such reports?
If you are a manufacturer, when you obtain information required
under this part that you did not provide because it was not known or was
not available when you submitted the initial report, you must submit the
supplemental information to us within 30 calendar days of the day that
you receive this information. You must submit the supplemental or
followup report in accordance with the requirements of Sec. 803.12(a).
On a supplemental or followup report, you must:
(a) Indicate that the report being submitted is a supplemental or
followup report;
(b) Submit the appropriate identification numbers of the report that
you are updating with the supplemental information (e.g., your original
manufacturer report number and the user facility or importer report
number of any report on which your report was based), if applicable; and
(c) Include only the new, changed, or corrected information.
Sec. 803.58 Foreign manufacturers.
(a) Every foreign manufacturer whose devices are distributed in the
United States shall designate a U.S. agent to be responsible for
reporting in accordance with Sec. 807.40 of this chapter. The U.S.
designated agent accepts responsibility for the duties that such
designation entails. Upon the effective date of this regulation, foreign
manufacturers shall inform FDA, by letter, of the name and address of
the U.S. agent designated under this section and Sec. 807.40 of this
chapter, and shall update this information as necessary. Such updated
information shall be submitted to FDA, within 5 days of a change in the
designated agent information.
(b) U.S.-designated agents of foreign manufacturers are required to:
(1) Report to FDA in accordance with Sec. Sec. 803.50, 803.52,
803.53, and 803.56;
(2) Conduct, or obtain from the foreign manufacturer the necessary
information regarding, the investigation and evaluation of the event to
comport with the requirements of Sec. 803.50;
(3) Forward MDR complaints to the foreign manufacturer and maintain
documentation of this requirement;
(4) Maintain complaint files in accordance with Sec. 803.18; and
(5) Register, list, and submit premarket notifications in accordance
with part 807 of this chapter.
Effective Date Note: At 79 FR 8846, Feb. 14, 2014, part 803 was
revised. At 79 FR 8855, Feb. 14, 2014, Sec. 803.58 was stayed
indefinitely.
PART 806_MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--
Table of Contents
Subpart A_General Provisions
Sec.
806.1 Scope.
806.2 Definitions.
Subpart B_Reports and Records
806.10 Reports of corrections and removals.
806.20 Records of corrections and removals not required to be reported.
806.30 FDA access to records.
806.40 Public availability of reports.
[[Page 68]]
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 62 FR 27191, May 19, 1997, unless otherwise noted.
Subpart A_General Provisions
Sec. 806.1 Scope.
(a) This part implements the provisions of section 519(g) of the
Federal Food, Drug, and Cosmetic Act (the act) requiring device
manufacturers and importers to report promptly to the Food and Drug
Administration (FDA) certain actions concerning device corrections and
removals, and to maintain records of all corrections and removals
regardless of whether such corrections and removals are required to be
reported to FDA.
(b) The following actions are exempt from the reporting requirements
of this part:
(1) Actions taken by device manufacturers or importers to improve
the performance or quality of a device but that do not reduce a risk to
health posed by the device or remedy a violation of the act caused by
the device.
(2) Market withdrawal as defined in Sec. 806.2(i)
(3) Routine servicing as defined in Sec. 806.2(l).
(4) Stock recovery as defined in Sec. 806.2(m).
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 84
FR 12083, Apr. 1, 2019]
Sec. 806.2 Definitions.
As used in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency or FDA means the Food and Drug Administration.
(c) Consignee means any person or firm that has received, purchased,
or used a device subject to correction or removal.
(d) Correction means the repair, modification, adjustment,
relabeling, destruction, or inspection (including patient monitoring) of
a device without its physical removal from its point of use to some
other location.
(e) Correction or removal report number means the number that
uniquely identifies each report submitted.
(f) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of
this chapter that does not meet the criteria in Sec. 1271.10(a) and
that is also regulated as a device.
(g) Importer means, for the purposes of this part, any person who
imports a device into the United States.
(h) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device by chemical,
physical, biological, or other procedures. The term includes any person
who:
(1) Repackages or otherwise changes the container, wrapper, or
labeling of a device in furtherance of the distribution of the device
from the original place of manufacture to the person who makes final
delivery or sale to the ultimate user or consumer;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications; or
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed and
are intended to be used as is, or are processed by a licensed
practitioner or other qualified person to meet the needs of a particular
patient.
(i) Market withdrawal means a correction or removal of a distributed
device that involves a minor violation of the act that would not be
subject to legal action by FDA or that involves no violation of the act,
e.g., normal stock rotation practices.
(j) Removal means the physical removal of a device from its point of
use to some other location for repair, modification, adjustment,
relabeling, destruction, or inspection.
(k) Risk to health means
(1) A reasonable probability that use of, or exposure to, the
product will cause serious adverse health consequences or death; or
(2) That use of, or exposure to, the product may cause temporary or
medically reversible adverse health consequences, or an outcome where
the probability of serious adverse health consequences is remote.
[[Page 69]]
(l) Routine servicing means any regularly scheduled maintenance of a
device, including the replacement of parts at the end of their normal
life expectancy, e.g., calibration, replacement of batteries, and
responses to normal wear and tear. Repairs of an unexpected nature,
replacement of parts earlier than their normal life expectancy, or
identical repairs or replacements of multiple units of a device are not
routine servicing.
(m) Stock recovery means the correction or removal of a device that
has not been marketed or that has not left the direct control of the
manufacturer, i.e., the device is located on the premises owned, or
under the control of, the manufacturer, and no portion of the lot,
model, code, or other relevant unit involved in the corrective or
removal action has been released for sale or use.
(n) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec. 830.20 of this chapter. A UDI is
composed of:
(1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
(2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.
(v) For an HCT/P regulated as a device, the distinct identification
code required by Sec. 1271.290(c) of this chapter.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 78
FR 58821, Sept. 24, 2013]
Subpart B_Reports and Records
Sec. 806.10 Reports of corrections and removals.
(a) Each device manufacturer or importer shall submit a written
report to FDA of any correction or removal of a device initiated by such
manufacturer or importer if the correction or removal was initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may
present a risk to health unless the information has already been
provided as set forth in paragraph (f) of this section or the corrective
or removal action is exempt from the reporting requirements under Sec.
806.1(b).
(b) The manufacturer or importer shall submit any report required by
paragraph (a) of this section within 10-working days of initiating such
correction or removal.
(c) The manufacturer or importer shall include the following
information in the report:
(1) The seven digit registration number of the entity responsible
for submission of the report of corrective or removal action (if
applicable), the month, day, and year that the report is made, and a
sequence number (i.e., 001 for the first report, 002 for the second
report, 003 etc.), and the report type designation ``C'' or ``R''. For
example, the complete number for the first correction report submitted
on June 1, 1997, will appear as follows for a firm with the registration
number 1234567: 1234567-6/1/97-001-C. The second correction report
number submitted by the same firm on July 1, 1997, would be 1234567-7/1/
97-002-C etc. For removals, the number will appear as follows: 1234567-
6/1/97-001-R and 1234567-7/1/97-002-R, etc. Firms that do not have a
seven digit registration number may use seven zeros followed by the
month, date, year, and sequence number (i.e. 0000000-6/1/97-001-C for
corrections and 0000000-7/1/97-001-R for removals). Reports received
without a seven digit registration number will be assigned a seven digit
central file number by the district office reviewing the reports.
(2) The name, address, and telephone number of the manufacturer or
importer, and the name, title, address, and telephone number of the
manufacturer or importer representative responsible for conducting the
device correction or removal.
(3) The brand name and the common name, classification name, or
usual
[[Page 70]]
name of the device and the intended use of the device.
(4) Marketing status of the device, i.e., any applicable premarket
notification number, premarket approval number, or indication that the
device is a preamendments device, and the device listing number. A
manufacturer or importer that does not have an FDA establishment
registration number shall indicate in the report whether it has ever
registered with FDA.
(5) The unique device identifier (UDI) that appears on the device
label or on the device package, or the device identifier, universal
product code (UPC), model, catalog, or code number of the device and the
manufacturing lot or serial number of the device or other identification
number.
(6) The manufacturer's name, address, telephone number, and contact
person if different from that of the person submitting the report.
(7) A description of the event(s) giving rise to the information
reported and the corrective or removal actions that have been, and are
expected to be taken.
(8) Any illness or injuries that have occurred with use of the
device. If applicable, include the medical device report numbers.
(9) The total number of devices manufactured or distributed subject
to the correction or removal and the number in the same batch, lot, or
equivalent unit of production subject to the correction or removal.
(10) The date of manufacture or distribution and the device's
expiration date or expected life.
(11) The names, addresses, and telephone numbers of all domestic and
foreign consignees of the device and the dates and number of devices
distributed to each such consignee.
(12) A copy of all communications regarding the correction or
removal and the names and addresses of all recipients of the
communications not provided in accordance with paragraph (c)(11) of this
section.
(13) If any required information is not immediately available, a
statement as to why it is not available and when it will be submitted.
(d) If, after submitting a report under this part, a manufacturer or
importer determines that the same correction or removal should be
extended to additional lots or batches of the same device, the
manufacturer or importer shall within 10-working days of initiating the
extension of the correction or removal, amend the report by submitting
an amendment citing the original report number assigned according to
paragraph (c)(1) of this section, all of the information required by
paragraph (c)(2), and any information required by paragraphs (c)(3)
through (c)(12) of this section that is different from the information
submitted in the original report. The manufacturer or importer shall
also provide a statement in accordance with paragraph (c)(13) of this
section for any required information that is not readily available.
(e) A report submitted by a manufacturer or importer under this
section (and any release by FDA of that report or information) does not
necessarily reflect a conclusion by the manufacturer, importer, or FDA
that the report or information constitutes an admission that the device
caused or contributed to a death or serious injury. A manufacturer or
importer need not admit, and may deny, that the report or information
submitted under this section constitutes an admission that the device
caused or contributed to a death or serious injury.
(f) No report of correction or removal is required under this part,
if a report of the correction or removal is required and has been
submitted under parts 803 or 1004 of this chapter.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 69
FR 11311, Mar. 10, 2004; 78 FR 58821, Sept. 24, 2013]
Sec. 806.20 Records of corrections and removals not required to be reported.
(a) Each device manufacturer or importer who initiates a correction
or removal of a device that is not required to be reported to FDA under
Sec. 806.10 shall keep a record of such correction or removal.
(b) Records of corrections and removals not required to be reported
to FDA under Sec. 806.10 shall contain the following information:
(1) The brand name, common or usual name, classification, name and
product
[[Page 71]]
code if known, and the intended use of the device.
(2) The unique device identifier (UDI) of the device, or the device
identifier, universal product code (UPC), model, catalog, or code number
of the device and the manufacturing lot or serial number of the device
or other identification number.
(3) A description of the event(s) giving rise to the information
reported and the corrective or removal action that has been, and is
expected to be taken.
(4) Justification for not reporting the correction or removal action
to FDA, which shall contain conclusions and any followups, and be
reviewed and evaluated by a designated person.
(5) A copy of all communications regarding the correction or
removal.
(c) The manufacturer or importer shall retain records required under
this section for a period of 2 years beyond the expected life of the
device, even if the manufacturer or importer has ceased to manufacture
or import the device. Records required to be maintained under paragraph
(b) of this section must be transferred to the new manufacturer or
importer of the device and maintained for the required period of time.
[62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998; 78
FR 58821, Sept. 24, 2013]
Sec. 806.30 FDA access to records.
Each device manufacturer or importer required under this part to
maintain records and every person who is in charge or custody of such
records shall, upon request of an officer or employee designated by FDA
and under section 704(e) of the act, permit such officer or employee at
all reasonable times to have access to, and to copy and verify, such
records and reports.
[63 FR 42233, Aug. 7, 1998]
Sec. 806.40 Public availability of reports.
(a) Any report submitted under this part is available for public
disclosure in accordance with part 20 of this chapter.
(b) Before public disclosure of a report, FDA will delete from the
report:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
and
(2) Any personnel, medical, or similar information, including the
serial numbers of implanted devices, which would constitute a clearly
unwarranted invasion of personal privacy under Sec. 20.63 of this
chapter or 5 U.S.C. 552(b)(6); provided, that except for the information
under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will
disclose to a patient who requests a report all the information in the
report concerning that patient.
PART 807_ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS
AND INITIAL IMPORTERS OF DEVICES--Table of Contents
Subpart A_General Provisions
Sec.
807.3 Definitions.
Subpart B_Procedures for Device Establishments
807.20 Who must register and submit a device list?
807.21 How to register establishments and list devices.
807.22 Times for establishment registration and device listing.
807.25 Information required for device establishment registration and
device listing.
807.26 Additional listing information.
807.28 Updating device listing information.
807.34 Summary of requirements for owners or operators granted a waiver
from submitting required information electronically.
807.35 Notification of registrant.
807.37 Public availability of establishment registration and device
listing information.
807.39 Misbranding by reference to establishment registration or to
registration number.
Subpart C_Procedures for Foreign Device Establishments
807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into
the United States.
807.41 Identification of importers and persons who import or offer for
import.
[[Page 72]]
Subpart D_Exemptions
807.65 Exemptions for device establishments.
Subpart E_Premarket Notification Procedures
807.81 When a premarket notification submission is required.
807.85 Exemption from premarket notification.
807.87 Information required in a premarket notification submission.
807.90 Format of a premarket notification submission.
807.92 Content and format of a 510(k) summary.
807.93 Content and format of a 510(k) statement.
807.94 Format of class III certification.
807.95 Confidentiality of information.
807.97 Misbranding by reference to premarket notification.
807.100 FDA action on a premarket notification.
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 807.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Commercial distribution means any distribution of a device
intended for human use which is held or offered for sale but does not
include the following:
(1) Internal or interplant transfer of a device between
establishments within the same parent, subsidiary, and/or affiliate
company;
(2) Any distribution of a device intended for human use which has in
effect an approved exemption for investigational use under section
520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part
812 of this chapter, that was not introduced or delivered for
introduction into interstate commerce for commercial distribution before
May 28, 1976, and that is classified into class III under section 513(f)
of the act: Provided, That the device is intended solely for
investigational use, and under section 501(f)(2)(A) of the act the
device is not required to have an approved premarket approval
application as provided in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that
is neither imported nor offered for import into the United States.
(c) Establishment means a place of business under one management at
one general physical location at which a device is manufactured,
assembled, or otherwise processed.
(d) Manufacture, preparation, propagation, compounding, assembly, or
processing of a device means the making by chemical, physical,
biological, or other procedures of any article that meets the definition
of device in section 201(h) of the act. These terms include the
following activities:
(1) Repackaging or otherwise changing the container, wrapper, or
labeling of any device package in furtherance of the distribution of the
device from the original place of manufacture to the person who makes
final delivery or sale to the ultimate consumer;
(2) Initial importation of devices manufactured in foreign
establishments; or
(3) Initiation of specifications for devices that are manufactured
by a second party for subsequent commercial distribution by the person
initiating specifications.
(e) Official correspondent means the person designated by the owner
or operator of an establishment as responsible for the following:
(1) The annual registration of the establishment;
(2) Contact with the Food and Drug Administration for device
listing;
(3) Maintenance and submission of a current list of officers and
directors to the Food and Drug Administration upon the request of the
Commissioner; and
(4) The receipt of pertinent correspondence from the Food and Drug
Administration directed to and involving the owner or operator and/or
any of the firm's establishments.
(f) Owner or operator means the corporation, subsidiary, affiliated
company, partnership, or proprietor directly responsible for the
activities of the registering establishment.
(g) Initial importer means any importer who furthers the marketing
of a
[[Page 73]]
device from a foreign manufacturer to the person who makes the final
delivery or sale of the device to the ultimate consumer or user, but
does not repackage, or otherwise change the container, wrapper, or
labeling of the device or device package.
(h) Any term defined in section 201 of the act shall have that
meaning.
(i) Restricted device means a device for which a requirement
restricting sale, distribution, or use has been established by a
regulation issued under section 520(e) of the act, by order as a
condition of premarket approval under section 515(d)(1)(B)(ii) of the
act, or by a performance standard issued in accordance with sections
514(a)(2)(B)(v) and 514(b) of the act.
(j) Classification name means the term used by the Food and Drug
Administration and its classification panels to describe a device or
class of devices for purposes of classifying devices under section 513
of the act.
(k) Product code means the code used by FDA to identify the generic
category of a device.
(l) Representative sampling of advertisements means typical
advertising material that gives the promotional claims made for the
device.
(m) Representative sampling of any other labeling means typical
labeling material (excluding labels and package inserts) that gives the
promotional claims made for the device.
(n) Material change includes any change or modification in the
labeling or advertisements that affects the identity or safety and
effectiveness of the device. These changes may include, but are not
limited to, changes in the common or usual or proprietary name, declared
ingredients or components, intended use, contraindications, warnings, or
instructions for use. Changes that are not material may include graphic
layouts, grammar, or correction of typographical errors which do not
change the content of the labeling, changes in lot number, and, for
devices where the biological activity or known composition differs with
each lot produced, the labeling containing the actual values for each
lot.
(o) 510(k) summary (summary of any information respecting safety and
effectiveness) means a summary, submitted under section 513(i) of the
act, of the safety and effectiveness information contained in a
premarket notification submission upon which a determination of
substantial equivalence can be based. Safety and effectiveness
information refers to safety and effectiveness data and information
supporting a finding of substantial equivalence, including all adverse
safety and effectiveness information.
(p) 510(k) statement means a statement, made under section 513(i) of
the act, asserting that all information in a premarket notification
submission regarding safety and effectiveness will be made available
within 30 days of request by any person if the device described in the
premarket notification submission is determined to be substantially
equivalent. The information to be made available will be a duplicate of
the premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers, and
trade secret or confidential commercial information, as defined in Sec.
20.61 of this chapter.
(q) Class III certification means a certification that the submitter
of the 510(k) has conducted a reasonable search of all known information
about the class III device and other similar, legally marketed devices.
(r) Class III summary means a summary of the types of safety and
effectiveness problems associated with the type of device being compared
and a citation to the information upon which the summary is based. The
summary must be comprehensive and describe the problems to which the
type of device is susceptible and the causes of such problems.
(s) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent. This definition excludes mailboxes, answering
machines or services, or other places where an individual acting as the
foreign establishment's agent is not physically present.
(t) Wholesale distributor means any person (other than the
manufacturer or the initial importer) who distributes a device from the
original place of manufacture to the person who makes the
[[Page 74]]
final delivery or sale of the device to the ultimate consumer or user.
(u) Fiscal year means the FDA fiscal year, which runs from October 1
through September 30.
(v) FURLS means the Food and Drug Administration's Unified
Registration and Listing System,
(w) FDA premarket submission number means the number assigned by FDA
to a premarket device submission, such as a Premarket Approval
Application (PMA); Humanitarian Device Exemption (HDE); New Drug
Application (NDA); Biologics License Application (BLA); de novo
classification petition; or Premarket Notification (510(k)).
(x) Importer means, for purposes of this part, a company or
individual in the United States that is an owner, consignee, or
recipient, even if not the initial owner, consignee, or recipient, of
the foreign establishment's device that is imported into the United
States. An importer does not include the consumer or patient who
ultimately purchases, receives, or uses the device, unless the foreign
establishment ships the device directly to the consumer or patient.
(y) Person who imports or offers for import means, for purposes of
this part, an agent, broker, or other entity, other than a carrier, that
the foreign establishment uses to facilitate the import of its device
into the United States.
[42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978;
57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295,
Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR 51826, Sept. 29, 1998;
66 FR 59159, Nov. 27, 2001; 77 FR 45940, Aug. 2, 2012]
Subpart B_Procedures for Device Establishments
Sec. 807.20 Who must register and submit a device list?
(a) An owner or operator of an establishment not exempt under
section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D
of this part who is engaged in the manufacture, preparation,
propagation, compounding, assembly, or processing of a device intended
for human use shall register and submit listing information for those
devices in commercial distribution, except that registration and listing
information may be submitted by the parent, subsidiary, or affiliate
company for all the domestic or foreign establishments under the control
of one of these organizations when operations are conducted at more than
one establishment and there exists joint ownership and control among all
the establishments. The term ``device'' includes all in vitro diagnostic
products and in vitro diagnostic biological products not subject to
licensing under section 351 of the Public Health Service Act. An owner
or operator of an establishment located in any State as defined in
section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall
register its name, places of business, and all establishments and list
the devices whether or not the output of the establishments or any
particular device so listed enters interstate commerce. The registration
and listing requirements shall pertain to any person who is engaged in
the manufacture, preparation, propagation, compounding, assembly, or
processing of a device intended for human use, including any person who:
(1) Initiates or develops specifications for a device that is to be
manufactured by a second party;
(2) Sterilizes or otherwise makes a device for or on behalf of a
specifications developer or any other person;
(3) Repackages or relabels a device;
(4) Reprocesses a single use device that has previously been used on
a patient;
(5) Acts as an initial importer as defined in Sec. 807.3(g), except
that initial importers may fulfill their listing obligation for any
device for which they did not initiate or develop the specifications for
the device or repackage or relabel the device by submitting the name and
address of the manufacturer. Initial importers shall also be prepared to
submit, when requested by FDA, the proprietary name, if any, and the
common or usual name of each device for which they are the initial
importer;
(6) Manufactures components or accessories that are ready to be used
for any intended health-related purpose
[[Page 75]]
and are packaged or labeled for commercial distribution for such health-
related purpose, e.g. blood filters, hemodialysis tubing, or devices
which of necessity must be further processed by a licensed practitioner
or other qualified person to meet the needs of a particular patient,
e.g., a manufacturer of ophthalmic lens blanks.
(b) Registration or listing does not constitute an admission or
agreement or determination that a product is a device within the meaning
of section 201(h) of the Federal Food, Drug, and Cosmetic Act.
(c) Registration and listing requirements shall not pertain to any
person who acts as a wholesale distributor, as defined in Sec.
807.3(t), and who does not manufacture, repackage, process, or relabel a
device.
(d) Owners and operators of establishments or persons engaged in the
recovery, screening, testing, processing, storage, or distribution of
human cells, tissues, and cellular and tissue-based products, as defined
in Sec. 1271.3(d) of this chapter, that are regulated under the Federal
Food, Drug, and Cosmetic Act must register and list those human cells,
tissues, and cellular and tissue-based products with the Center for
Biologics Evaluation and Research on Form FDA 3356 following the
procedures set out in subpart B of part 1271 of this chapter, instead of
the procedures for registration and listing contained in this part,
except that the additional listing information requirements of Sec.
807.26 remain applicable.
(e) Owners and operators of establishments that manufacture devices
licensed under section 351 of the Public Health Service Act as well as
licensed biological products used in the manufacture of a licensed
device must register and list following the procedures set out in part
607 of this chapter, instead of the procedures for registration and
listing contained in this part.
[77 FR 45941, Aug. 2, 2012]
Sec. 807.21 How to register establishments and list devices.
(a) Owners or operators of establishments that are subject to the
registration and listing requirements of this part must provide the
following information to us using our electronic device registration and
listing system, except as provided in paragraphs (b), (c), and (d) of
this section:
(1) Initial establishment registration information as required by
Sec. Sec. 807.22(a) and 807.25;
(2) Updates to registration information as required by Sec. Sec.
807.22(b) and 807.25;
(3) Initial device listing information as required by Sec. Sec.
807.22(a), 807.25, and 807.28;
(4) Updates to device listing information as required by Sec. Sec.
807.22(b), 807.25, and 807.28, including updates to reflect the
discontinuance or resumption of the commercial distribution of a
previously-listed device as specified at paragraphs (d) and (e) of Sec.
807.28.
(b) If the information under Sec. 807.21(a) cannot be submitted
electronically, a waiver may be requested. Waivers will be granted only
if use of electronic means is not reasonable for the person requesting
the waiver. To request a waiver, applicants must send a letter to the
Office of Compliance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2621,
Silver Spring, MD 20993-0002, that includes the following information:
(1) The name and address of the device establishment(s) to be
registered, a contact person for the owner or operator of the
establishment, and the telephone number at which that person can be
reached. If the establishment has already registered in the past, the
letter should also include the owner or operator number, registration
number, and any listing numbers previously assigned by FDA for devices
manufactured at that establishment.
(2) Information about whether the company is an initial importer as
defined in Sec. 807.3(g) and, if so, whether it also conducts any other
activities or operations relating to devices.
(3) A statement that use of the Internet is not reasonable for the
person requesting the waiver, and an explanation of why such use is not
reasonable. The statement must be signed by the owner or operator of the
establishment, or by a person employed by the owner or operator who is
authorized to make the declaration on behalf of the owner or operator.
[[Page 76]]
(c) Those owners or operators who have obtained a waiver from filing
registration and listing information electronically should refer to
Sec. 807.34 for information on how to submit such information by postal
mail.
(d) When additional device listing information (e.g., copies of
labeling or advertisements) is requested by FDA as described at Sec.
807.26(e), such information may be submitted by postal mail or
electronically by email, but will not be submitted using the FDA
electronic device registration and listing system.
[77 FR 45941, Aug. 2, 2012]
Sec. 807.22 Times for establishment registration and device listing.
(a) Initial registration and listing. An owner or operator of an
establishment who has not previously entered into an operation described
in Sec. 807.20(a) shall register within 30 days after entering into
such an operation and submit device listing information at that time.
(b) Registration and listing updates. Owners or operators shall
review and update all of their establishment registration and device
listing information that is on file at FDA, documenting any changes that
were not previously reported as follows:
(1) Annual registration for each fiscal year is required for all
establishments. Annual registration shall take place during the period
beginning on October 1 and ending on December 31 of each fiscal year;
(2) Updates to the registration information as described in Sec.
807.25(b) shall be made within 30 days of any change to such
information;
(3) Every fiscal year, during the period beginning on October 1 and
ending on December 31, owners or operators shall review and update all
of their device listing information that is on file at FDA, reporting
any changes or deletions to listings and any new listings that were not
previously reported. The accuracy of all information on file must be
confirmed each year regardless of whether any changes were made to the
owner or operator's list of devices; and
(4) Changes to listing information may also be made at other times,
such as when a device is introduced into commercial distribution, when a
change is made to a previously-listed device, or when a previously-
listed device is removed from commercial distribution.
(c) Failure to submit required information. Failure to submit any of
the required information on time, as specified in paragraphs (a) and (b)
of this section, will put the establishment in a ``failed to register''
or ``failed to list'' status as applicable. The establishment will not
be considered active and the establishment registration and device
listing information may not appear on the FDA Web site until such time
as the owner or operator submits and FDA processes the required
information.
[77 FR 45942, Aug. 2, 2012]
Sec. 807.25 Information required for device establishment registration
and device listing.
(a) All owners or operators that are subject to the registration and
listing requirements of this part shall provide such information to us
by using the FDA electronic device registration and listing system,
unless granted a waiver from electronic submission in accordance with
Sec. 807.21(b). Electronic submissions of registration and listing
information must comply with part 11 of this chapter, except for the
requirements in Sec. 11.10(b), (c), and (e), and the corresponding
requirements in Sec. 11.30 of this chapter. Those owners or operators
granted a waiver from electronic submission should refer to paragraphs
(c) and (g) of this section and Sec. 807.34 for instructions on how to
submit device registration and listing information.
(b) Registration information required to be submitted includes: The
name and mailing address of the device establishment; the Web site
address of the device establishment, if any; the name, address, phone
number, fax number, and email address of the owner or operator; the
name, address, phone number, fax number, and email address of the
establishment's official correspondent; and all trade names used by the
establishment.
(c) Owners or operators who have been granted a waiver from
electronic filing must submit the establishment registration information
described in
[[Page 77]]
paragraph (b) of this section, except for the Web site and email address
information, in paper form using the procedures set forth in Sec.
807.34.
(d) Each owner or operator is required to maintain a listing of all
officers, directors, and partners for each establishment registered by
the owner or operator and to furnish this information to FDA upon
request.
(e) For each establishment, an official correspondent must be
designated by the owner or operator to serve as a point of contact with
FDA on matters relating to the registration of device establishments and
the listing of device products. Each owner or operator shall also
provide FDA with the name of a contact person at the owner or operator's
offices who will be responsible for identifying the official
correspondent for each establishment. The owner or operator contact
person will be the official correspondent in the event no one else has
been properly designated. The official correspondent is responsible for:
(1) Providing FDA with all required registration and listing
information electronically unless a waiver from electronic submission
has been granted in accordance with Sec. 807.21(b);
(2) Receiving all correspondence from FDA concerning registration
and listing;
(3) Supplying, when requested by FDA, the names of all officers,
directors, and partners; and
(4) Receiving communications from FDA by email, or by postal mail if
the owner or operator has been granted a waiver from the requirement to
file registration and listing information electronically.
(f) The designation of an official correspondent does not in any
manner affect the liability of the owner or operator of the
establishment or any other individual under section 301(p) or any other
provision of the Federal Food, Drug, and Cosmetic Act.
(g) Device listing information must be submitted to FDA
electronically unless a waiver from electronic submission has been
granted in accordance with Sec. 807.21(b). Owners or operators who have
been granted a waiver must submit the required device listing
information, including information required by this paragraph, Sec.
807.28, and any listing information requested by FDA under Sec.
807.26(e), in paper form using the procedures set forth in Sec. 807.34.
The information required for each device listed includes:
(1) The current registration number and name of each establishment
under the ownership and control of the owner or operator where the
device is manufactured, repackaged, relabeled, or otherwise processed,
or where specifications are developed.
(2) The product code for each device that is exempt from premarket
notification and approval or which was in commercial distribution prior
to May 28, 1976.
(3) The proprietary or brand name(s) under which each device is
marketed.
(4) The FDA-assigned premarket submission number of the approved
application, cleared premarket notification, granted de novo
classification petition, or approved humanitarian device exemption for
each device listed that is subject to sections 505, 510(k), 513(f)(2),
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, which
includes devices that are not exempt from premarket notification and
approval.
(5) Each activity or process that is conducted on or done to the
device at each establishment, such as manufacturing, repacking,
relabeling, developing specifications, remanufacturing, single-use
device reprocessing, contract manufacturing, contract sterilizing, or
manufacturing for export only.
[77 FR 45942, Aug. 2, 2012]
Sec. 807.26 Additional listing information.
(a) Each owner or operator shall maintain a historical file
containing the labeling and advertisements in use on the date of initial
listing, and in use after October 10, 1978, but before the date of
initial listing, as follows:
(1) For each device subject to section 514 or 515 of the act that is
not a restricted device, a copy of all labeling for the device;
(2) For each restricted device, a copy of all labeling and
advertisements for the device;
(3) For each device that is neither restricted nor subject to
section 514 or
[[Page 78]]
515 of the act, a copy of all labels, package inserts, and a
representative sampling of any other labeling.
(b) In addition to the requirements set forth in paragraph (a) of
this section, each owner or operator shall maintain in the historical
file any labeling or advertisements in which a material change has been
made anytime after initial listing.
(c) Each owner or operator may discard labeling and advertisements
from the historical file 3 years after the date of the last shipment of
a discontinued device by an owner or operator.
(d) Location of the file:
(1) Currently existing systems for maintenance of labeling and
advertising may be used for the purpose of maintaining the historical
file as long as the information included in the systems fulfills the
requirements of this section, but only if the labeling and
advertisements are retrievable in a timely manner.
(2) The contents of the historical file may be physically located in
more than one place in the establishment or in more than one
establishment provided there exists joint ownership and control among
all the establishments maintaining the historical file. If no joint
ownership and control exists, the registered establishment must provide
the Food and Drug Administration with a letter authorizing the
establishment outside its control to maintain the historical file.
(3) A copy of the certification and disclosure statements as
required by part 54 of this chapter shall be retained and physically
located at the establishment maintaining the historical file.
(e) Each owner or operator shall be prepared to submit to the Food
and Drug Administration, only upon specific request, the following
information:
(1) For a device subject to section 514 or 515 of the act that is
not a restricted device, a copy of all labeling for the device.
(2) For a device that is a restricted device, a copy of all labeling
for the device, a representative sampling of advertisements for the
device, and for good cause, a copy of all advertisements for a
particular device. A request for all advertisements will, where
feasible, be accompanied by an explanation of the basis for such
request.
(3) For a device that is neither a restricted device, nor subject to
section 514 of 515 of the act, the label and package insert for the
device and a representative sampling of any other labeling for the
device.
(4) For a particular device, a statement of the basis upon which the
registrant has determined that the device is not subject to section 514
or 515 of the act.
(5) For a particular device, a statement of the basis upon which the
registrant has determined the device is not a restricted device.
(6) For a particular device, a statement of the basis for
determining that the product is a device rather than a drug.
(7) For a device that the owner or operator has manufactured for
distribution under a label other than its own, the names of all
distributors for whom it has been manufactured.
(f) Labeling, advertisements, and other information to be submitted
upon request in accordance with paragraph (e) of this section may be
submitted by postal mail or electronically by email, but will not be
submitted using the FDA electronic device registration and listing
system. Electronic submissions of such information must comply with part
11 of this chapter, except for the requirements in Sec. 11.10 (a), (c)
through (h), and (k), and the corresponding requirements in Sec. 11.30
of this chapter. The information provided in electronic format must be
in a form that we can process, review, and archive.
[43 FR 37999, Aug. 25, 1978, as amended at 51 FR 33033, Sept. 18, 1986;
63 FR 5253, Feb. 2, 1998. Redesignated and amended at 77 FR 45943, Aug.
2, 2012]
Sec. 807.28 Updating device listing information.
(a) Updating of device listing information is required if an
additional establishment begins to engage in any of the activities
described in Sec. 807.3(d) with respect to a listed device, such as
manufacturing, developing specifications, repackaging, relabeling, or
otherwise processing the device. Updating
[[Page 79]]
of the listing is also required if an establishment begins performing
another activity on or to the device, or ceases to perform an activity
on or to the device that had previously been identified on the device
listing.
(b) An owner or operator shall create a new device listing using the
FDA electronic device registration and listing system:
(1) If introducing into commercial distribution an exempt device
identified with a product code that is not currently listed by the owner
or operator; or
(2) If introducing into commercial distribution a non-exempt device
with an FDA premarket submission number that is not currently listed by
the owner or operator.
(c) All device listings for foreign establishments must be submitted
before the device may be imported or offered for import into the United
States.
(d) An owner or operator who discontinues commercial distribution of
a device shall discontinue the device listing using the FDA electronic
device registration and listing system. A device listing is considered
discontinued if:
(1) All devices under an exempt product code have been discontinued
or
(2) All devices associated with an FDA premarket submission number
have been discontinued.
(e) If commercial distribution of a discontinued device is resumed,
the owner or operator must reactivate the previously-discontinued
listing using the electronic device registration and listing system. Any
changes to the listing information for the product that is the subject
of the listing such as a new establishment, new activity, or new
proprietary name must be made using the electronic device registration
and listing system at the time the listing is reactivated.
(f) FDA will assign one listing number for all devices exempt from
premarket notification requirements under a single product code. For
products not exempt from premarket notification requirements, a single
listing number will be assigned by FDA for each FDA premarket submission
number.
[77 FR 45943, Aug. 2, 2012]
Sec. 807.34 Summary of requirements for owners or operators granted
a waiver from submitting required information electronically.
(a) For initial registration and listing, owners or operators who
have been granted a waiver from electronic filing using the procedures
set forth in Sec. 807.21(b) must send a letter containing all of the
registration and listing information described in Sec. Sec. 807.22,
807.25, (and Sec. 807.26 when such information is requested by FDA), at
the times described in Sec. 807.22, to: The Office of Compliance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver
Spring, MD 20993-0002.
(b) As specified in Sec. 807.22(b)(1) and (b)(3), all owners or
operators shall update their establishment registration and device
listings annually during the period beginning on October 1 and ending on
December 31 of each fiscal year.
(c) Failure to submit any of the required information on time, as
specified in Sec. 807.22(a) and (b), will put the establishment in a
``failed to register'' or ``failed to list'' status as applicable.
The establishment will not be considered active and the
establishment registration and device listing information may not appear
on the FDA Web site until the required information is submitted to and
processed by FDA.
[77 FR 45943, Aug. 2, 2012]
Sec. 807.35 Notification of registrant.
(a) The Food and Drug Administration will assign each device
establishment a registration number after verifying the initial
establishment registration information that has been submitted. The
owner or operator of the establishment will also be assigned an
identifying number. Both numbers will be sent to the official
correspondent by email, or by postal mail if the owner or operator has
been granted a waiver from the requirement to file registration and
listing information electronically.
(b) Owners or operators of device establishments who also
manufacture or process biological products (including devices licensed
under section 351 of the Public Health Service Act) or drug products at
the same establishment
[[Page 80]]
must also register and list those products under part 607 or part 207 of
this chapter, as appropriate. Registration and listing for human blood
and blood products, devices licensed under section 351 of the Public
Health Service Act, and licensed biological products used in the
manufacture of a device licensed under section 351 of the Public Health
Service Act, are subject to part 607 of this chapter; registration and
listing for all other drug products (including other biological products
that are also regulated as drug products) are subject to part 207 of
this chapter.
(c) Although establishment registration and device listing are
required to engage in the device activities described in Sec. 807.20,
validation of registration and the assignment of a device listing number
in itself does not establish that the holder of the registration is
legally qualified to deal in such devices and does not represent a
determination by the Food and Drug Administration as to the status of
any device.
[69 FR 11312, Mar. 10, 2004, as amended at 77 FR 45943, Aug. 2, 2012]
Sec. 807.37 Public availability of establishment registration
and device listing information.
(a) Establishment registration and device listing information is
available for public inspection in accordance with section 510(f) of the
Federal Food, Drug, and Cosmetic Act and will be posted on the FDA Web
site, with the exception of the information identified in paragraph (b)
of this section. Requests for information by persons who do not have
access to the Internet should be directed to the Office of Compliance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver
Spring, MD 20993-0002. In addition, there will be available for
inspection at each of the Food and Drug Administration district offices
the same information for firms within the geographical area of such
district offices. Upon request, verification of a registration number or
location of a registered establishment will be provided.
(b) The following listing information will not be available for
public inspection or posted on the FDA Web site:
(1) For contract manufacturers, contract sterilizers, and private
label manufacturers, the proprietary or brand name(s) under which a
device is marketed and the FDA-assigned premarket submission number, if
this information would reveal a confidential business relationship;
(2) FDA-assigned listing numbers.
[77 FR 45943, Aug. 2, 2012]
Sec. 807.39 Misbranding by reference to establishment registration
or to registration number.
Registration of a device establishment or assignment of a
registration number does not in any way denote approval of the
establishment or its products. Any representation that creates an
impression of official approval because of registration or possession of
a registration number is misleading and constitutes misbranding.
Subpart C_Procedures for Foreign Device Establishments
Sec. 807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into the United States.
(a) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
device that is imported or offered for import into the United States
shall register such establishment and list such devices using the FDA
electronic device registration and listing system in conformance with
the procedures in this section, Sec. 807.41, and subpart B of this
part. The official correspondent for the foreign establishment shall
facilitate communication between the foreign establishment's management
and representatives of FDA for matters relating to the registration of
device establishments and the listing of device products.
(b) Each foreign establishment required to register under paragraph
(a) of this section shall submit the name, address, and phone number of
its
[[Page 81]]
United States agent as part of its initial and updated registration
information in accordance with subpart B of this part. Each foreign
establishment shall designate only one United States agent and may
designate the United States agent to act as its official correspondent.
(1) The United States agent shall reside or maintain a place of
business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA
in communications with the foreign establishment, respond to questions
concerning the foreign establishment's products that are imported or
offered for import into the United States, and assist FDA in scheduling
inspections of the foreign establishment. If the agency is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information or documents to the United States agent, and such an
action shall be considered to be equivalent to providing the same
information or documents to the foreign establishment.
(3) The foreign establishment or the United States agent shall
report changes in the United States agent's name, address, or phone
number to FDA within 10-business days of the change.
(c) No device may be imported or offered for import into the United
States unless it is the subject of a device listing as required under
subpart B of this part and is manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment; however,
this restriction does not apply to devices imported or offered for
import under the investigational use provisions of part 812 of this
chapter.
(d) The device establishment registration and device listing
information shall be in the English language.
[66 FR 59160, Nov. 27, 2001, as amended at 77 FR 45944, Aug. 2, 2012]
Sec. 807.41 Identification of importers and persons who import
or offer for import.
(a) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone and
fax numbers, email address, and registration number, if any has been
assigned, of any importer (defined in Sec. 807.3(x)) of the
establishment's devices that is known to the foreign establishment. The
foreign establishment must also specify which of the establishment's
listed products each importer receives from the foreign establishment.
(b) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone and
fax numbers, email address, and registration number, if any has been
assigned, of each person who imports or offers for import the
establishment's devices into the United States. The term ``person who
imports or offers for import,'' which is defined in Sec. 807.3(y),
includes agents, brokers, or other parties used by the foreign
establishment to facilitate the import of its device into the United
States.
(c) For each individual or organization identified by the foreign
establishment under paragraphs (a) and (b) of this section, the foreign
establishment must submit to FDA electronically the current FDA
premarket submission number and any other identifying information that
is known to the establishment for each device being imported or offered
for import by the named individuals or organizations.
[77 FR 45944, Aug. 2, 2012]
Subpart D_Exemptions
Sec. 807.65 Exemptions for device establishments.
The following classes of persons are exempt from registration in
accordance with Sec. 807.20 under the provisions of section 510(g)(1),
(g)(2), and (g)(3) of the act, or because the Commissioner of Food and
Drugs has found, under section 510(g)(5) of the act, that such
registration is not necessary for the protection of the public health.
The exemptions in paragraphs (d), (e), (f), and (i) of this section are
limited to those classes of persons located in any State
[[Page 82]]
as defined in section 201(a)(1) of the act.
(a) A manufacturer of raw materials or components to be used in the
manufacture or assembly of a device who would otherwise not be required
to register under the provisions of this part.
(b) A manufacturer of devices to be used solely for veterinary
purposes.
(c) A manufacturer of general purpose articles such as chemical
reagents or laboratory equipment whose uses are generally known by
persons trained in their use and which are not labeled or promoted for
medical uses.
(d) Licensed practitioners, including physicians, dentists, and
optometrists, who manufacture or otherwise alter devices solely for use
in their practice.
(e) Pharmacies, surgical supply outlets, or other similar retail
establishments making final delivery or sale to the ultimate user. This
exemption also applies to a pharmacy or other similar retail
establishment that purchases a device for subsequent distribution under
its own name, e.g., a properly labeled health aid such as an elastic
bandage or crutch, indicating ``distributed by'' or ``manufactured for''
followed by the name of the pharmacy.
(f) Persons who manufacture, prepare, propagate, compound, or
process devices solely for use in research, teaching, or analysis and do
not introduce such devices into commercial distribution.
(g) [Reserved]
(h) Carriers by reason of their receipt, carriage, holding or
delivery of devices in the usual course of business as carriers.
(i) Persons who dispense devices to the ultimate consumer or whose
major responsibility is to render a service necessary to provide the
consumer (i.e., patient, physician, layman, etc.) with a device or the
benefits to be derived from the use of a device; for example, a hearing
aid dispenser, optician, clinical laboratory, assembler of diagnostic x-
ray systems, and personnel from a hospital, clinic, dental laboratory,
orthotic or prosthetic retail facility, whose primary responsibility to
the ultimate consumer is to dispense or provide a service through the
use of a previously manufactured device.
[42 FR 42526, Aug. 23, 1977, as amended at 58 FR 46523, Sept. 1, 1993;
61 FR 44615, Aug. 28, 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160,
Nov. 27, 2001]
Subpart E_Premarket Notification Procedures
Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person
who is required to register his establishment pursuant to Sec. 807.20
must submit a premarket notification submission to the Food and Drug
Administration at least 90 days before he proposes to begin the
introduction or delivery for introduction into interstate commerce for
commercial distribution of a device intended for human use which meets
any of the following criteria:
(1) The device is being introduced into commercial distribution for
the first time; that is, the device is not of the same type as, or is
not substantially equivalent to, (i) a device in commercial distribution
before May 28, 1976, or (ii) a device introduced for commercial
distribution after May 28, 1976, that has subsequently been reclassified
into class I or II.
(2) The device is being introduced into commercial distribution for
the first time by a person required to register, whether or not the
device meets the criteria in paragraph (a)(1) of this section.
(3) The device is one that the person currently has in commercial
distribution or is reintroducing into commercial distribution, but that
is about to be significantly changed or modified in design, components,
method of manufacture, or intended use. The following constitute
significant changes or modifications that require a premarket
notification:
(i) A change or modification in the device that could significantly
affect the safety or effectiveness of the device, e.g., a significant
change or modification in design, material, chemical composition, energy
source, or manufacturing process.
(ii) A major change or modification in the intended use of the
device.
[[Page 83]]
(b)(1) A premarket notification under this subpart is not required
for a device for which a premarket approval application under section
515 of the act, or for which a petition to reclassify under section
513(f)(2) of the act, is pending before the Food and Drug
Administration.
(2) The appropriate FDA Center Director may determine that the
submission and grant of a written request for an exception or
alternative under Sec. 801.128 or Sec. 809.11 of this chapter
satisfies the requirement in paragraph (a)(3) of this section.
(c) In addition to complying with the requirements of this part,
owners or operators of device establishments that manufacture radiation-
emitting electronic products, as defined in Sec. 1000.3 of this
chapter, shall comply with the reporting requirements of part 1002 of
this chapter.
[42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007]
Sec. 807.85 Exemption from premarket notification.
(a) A custom device is exempt from premarket notification
requirements of this subpart if the device is within the meaning of
section 520(b) of the Federal Food, Drug, and Cosmetic Act.
(1) It is intended for use by a patient named in the order of the
physician or dentist (or other specially qualified person); or
(2) It is intended solely for use by a physician or dentist (or
other specially qualified person) and is not generally available to, or
generally used by, other physicians or dentists (or other specially
qualified persons).
(b) A distributor who places a device into commercial distribution
for the first time under his own name and a repackager who places his
own name on a device and does not change any other labeling or otherwise
affect the device shall be exempted from the premarket notification
requirements of this subpart if:
(1) The device was in commercial distribution before May 28, 1976;
or
(2) A premarket notification submission was filed by another person.
[42 FR 42526, Aug. 23, 1977, as amended at 81 FR 70340, Oct. 12, 2016]
Sec. 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following
information:
(a) The device name, including both the trade or proprietary name
and the common or usual name or classification name of the device.
(b) The establishment registration number, if applicable, of the
owner or operator submitting the premarket notification submission.
(c) The class in which the device has been put under section 513 of
the act and, if known, its appropriate panel; or, if the owner or
operator determines that the device has not been classified under such
section, a statement of that determination and the basis for the
person's determination that the device is not so classified.
(d) Action taken by the person required to register to comply with
the requirements of the act under section 514 for performance standards.
(e) Proposed labels, labeling, and advertisements sufficient to
describe the device, its intended use, and the directions for its use.
Where applicable, photographs or engineering drawings should be
supplied.
(f) A statement indicating the device is similar to and/or different
from other products of comparable type in commercial distribution,
accompanied by data to support the statement. This information may
include an identification of similar products, materials, design
considerations, energy expected to be used or delivered by the device,
and a description of the operational principles of the device.
(g) Where a person required to register intends to introduce into
commercial distribution a device that has undergone a significant change
or modification that could significantly affect the safety or
effectiveness of the device, or the device is to be marketed for a new
or different indication for use, the premarket notification submission
must include appropriate supporting data to show that the manufacturer
has considered what consequences and effects the change or modification
or new use might have on the safety and effectiveness of the device.
[[Page 84]]
(h) A 510(k) summary as described in Sec. 807.92 or a 510(k)
statement as described in Sec. 807.93.
(i) A financial certification or disclosure statement or both, as
required by part 54 of this chapter.
(j) For a submission supported by clinical data:
(1) If the data are from clinical investigations conducted in the
United States, a statement that each investigation was conducted in
compliance with applicable requirements in the protection of human
subjects regulations in part 50 of this chapter, the institutional
review boards regulations in part 56 of this chapter, or was not subject
to the regulations under Sec. 56.104 or Sec. 56.105, and the
investigational device exemptions regulations in part 812 of this
chapter, or if the investigation was not conducted in compliance with
those regulations, a brief statement of the reason for the
noncompliance.
(2) If the data are from clinical investigations conducted outside
the United States, the requirements under Sec. 812.28 of this chapter
apply. If any such investigation was not conducted in accordance with
good clinical practice (GCP) as described in Sec. 812.28(a) of this
chapter, include either a waiver request in accordance with Sec.
812.28(c) of the chapter or a brief statement of the reason for not
conducting the investigation in accordance with GCP and a description of
steps taken to ensure that the data and results are credible and
accurate and that the rights, safety, and well-being of subjects have
been adequately protected.
(k) For submissions claiming substantial equivalence to a device
which has been classified into class III under section 513(b) of the
act:
(1) Which was introduced or delivered for introduction into
interstate commerce for commercial distribution before December 1, 1990;
and
(2) For which no final regulation requiring premarket approval has
been issued under section 515(b) of the act, a summary of the types of
safety and effectiveness problems associated with the type of devices
being compared and a citation to the information upon which the summary
is based (class III summary). The 510(k) submitter shall also certify
that a reasonable search of all information known or otherwise available
about the class III device and other similar legally marketed devices
has been conducted (class III certification), as described in Sec.
807.94. This information does not refer to information that already has
been submitted to the Food and Drug Administration (FDA) under section
519 of the act. FDA may require the submission of the adverse safety and
effectiveness data described in the class III summary or citation.
(l) A statement that the submitter believes, to the best of his or
her knowledge, that all data and information submitted in the premarket
notification are truthful and accurate and that no material fact has
been omitted.
(m) Any additional information regarding the device requested by the
Commissioner that is necessary for the Commissioner to make a finding as
to whether or not the device is substantially equivalent to a device in
commercial distribution. A request for additional information will
advise the owner or operator that there is insufficient information
contained in the original premarket notification submission for the
Commissioner to make this determination and that the owner or operator
may either submit the requested data or a new premarket notification
containing the requested information at least 90 days before the owner
or operator intends to market the device, or submit a premarket approval
application in accordance with section 515 of the act. If the additional
information is not submitted within 30 days following the date of the
request, the Commissioner will consider the premarket notification to be
withdrawn.
(Information collection requirements in this section were approved by
the Office of Management and Budget (OMB) and assigned OMB control
number 0910-0281)
[42 FR 42526, Aug. 23, 1977, as amended at 57 FR 18066, Apr. 28, 1992;
59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998; 83 FR 7385, Feb.
21, 2018]
[[Page 85]]
Sec. 807.90 Format of a premarket notification submission.
Each premarket notification submission pursuant to this part shall
be submitted in accordance with this section. Each submission shall:
(a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the current address displayed on
the website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation and
Research, be addressed to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices
regulated by the Center for Drug Evaluation and Research, be addressed
to the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266. Information about devices regulated by the Center for
Biologics Evaluation and Research is available at https://www.fda.gov/
BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.
(3) All inquiries regarding a premarket notification submission
should be sent to the address in this section or one of the current
addresses displayed on the Food and Drug Administration's website.
(b) [Reserved]
(c) Be submitted as a single version in electronic format.
(d) Be submitted separately for each product the manufacturer
intends to market.
(e) Designated ``510(k) Notification'' in the cover letter.
[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55
FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, Mar.
24, 2005; 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR
68339, Dec. 16, 2019]
Sec. 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an
understanding of the basis for a determination of substantial
equivalence. FDA will accept summaries as well as amendments thereto
until such time as FDA issues a determination of substantial
equivalence. All 510(k) summaries shall contain the following
information:
(1) The submitter's name, address, telephone number, a contact
person, and the date the summary was prepared;
(2) The name of the device, including the trade or proprietary name
if applicable, the common or usual name, and the classification name, if
known;
(3) An identification of the legally marketed device to which the
submitter claims equivalence. A legally marketed device to which a new
device may be compared for a determination regarding substantial
equivalence is a device that was legally marketed prior to May 28, 1976,
or a device which has been reclassified from class III to class II or I
(the predicate), or a device which has been found to be substantially
equivalent through the 510(k) premarket notification process;
(4) A description of the device that is the subject of the premarket
notification submission, such as might be found in the labeling or
promotional material for the device, including an explanation of how the
device functions, the scientific concepts that form the basis for the
device, and the significant physical and performance characteristics of
the device, such as device design, material used, and physical
properties;
(5) A statement of the intended use of the device that is the
subject of the premarket notification submission, including a general
description of the diseases or conditions that the device will diagnose,
treat, prevent, cure, or mitigate, including a description, where
appropriate, of the patient population for which the device is intended.
If the indication statements are different from those of the legally
marketed device identified in paragraph (a)(3) of this section, the
510(k) summary shall contain an explanation as to why the differences
are not critical to the intended therapeutic, diagnostic, prosthetic, or
surgical use of the device, and why the differences do not affect the
safety and effectiveness of the device when used as labeled; and
[[Page 86]]
(6) If the device has the same technological characteristics (i.e.,
design, material, chemical composition, energy source) as the predicate
device identified in paragraph (a)(3) of this section, a summary of the
technological characteristics of the new device in comparison to those
of the predicate device. If the device has different technological
characteristics from the predicate device, a summary of how the
technological characteristics of the device compare to a legally
marketed device identified in paragraph (a)(3) of this section.
(b) 510(k) summaries for those premarket submissions in which a
determination of substantial equivalence is also based on an assessment
of performance data shall contain the following information:
(1) A brief discussion of the nonclinical tests submitted,
referenced, or relied on in the premarket notification submission for a
determination of substantial equivalence;
(2) A brief discussion of the clinical tests submitted, referenced,
or relied on in the premarket notification submission for a
determination of substantial equivalence. This discussion shall include,
where applicable, a description of the subjects upon whom the device was
tested, a discussion of the safety or effectiveness data obtained from
the testing, with specific reference to adverse effects and
complications, and any other information from the clinical testing
relevant to a determination of substantial equivalence; and
(3) The conclusions drawn from the nonclinical and clinical tests
that demonstrate that the device is as safe, as effective, and performs
as well as or better than the legally marketed device identified in
paragraph (a)(3) of this section.
(c) The summary should be in a separate section of the submission,
beginning on a new page and ending on a page not shared with any other
section of the premarket notification submission, and should be clearly
identified as a ``510(k) summary.''
(d) Any other information reasonably deemed necessary by the agency.
[57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994]
Sec. 807.93 Content and format of a 510(k) statement.
(a)(1) A 510(k) statement submitted as part of a premarket
notification shall state as follows:
I certify that, in my capacity as (the position held in company by
person required to submit the premarket notification, preferably the
official correspondent in the firm), of (company name), I will make
available all information included in this premarket notification on
safety and effectiveness within 30 days of request by any person if the
device described in the premarket notification submission is determined
to be substantially equivalent. The information I agree to make
available will be a duplicate of the premarket notification submission,
including any adverse safety and effectiveness information, but
excluding all patient identifiers, and trade secret and confidential
commercial information, as defined in 21 CFR 20.61.
(2) The statement in paragraph (a)(1) of this section should be
signed by the certifier, made on a separate page of the premarket
notification submission, and clearly identified as ``510(k) statement.''
(b) All requests for information included in paragraph (a) of this
section shall be made in writing to the certifier, whose name will be
published by FDA on the list of premarket notification submissions for
which substantial equivalence determinations have been made.
(c) The information provided to requestors will be a duplicate of
the premarket notification submission, including any adverse
information, but excluding all patient identifiers, and trade secret and
confidential commercial information as defined in Sec. 20.61 of this
chapter.
[59 FR 64295, Dec. 14, 1994]
Sec. 807.94 Format of a class III certification.
(a) A class III certification submitted as part of a premarket
notification shall state as follows:
I certify, in my capacity as (position held in company), of (company
name), that I have conducted a reasonable search of all information
known or otherwise available about the types and causes of safety or
effectiveness problems that have been reported for the (type of device).
I further certify that I am aware of the types of problems to which
[[Page 87]]
the (type of device) is susceptible and that, to the best of my
knowledge, the following summary of the types and causes of safety or
effectiveness problems about the (type of device) is complete and
accurate.
(b) The statement in paragraph (a) of this section should be signed
by the certifier, clearly identified as ``class III certification,'' and
included at the beginning of the section of the premarket notification
submission that sets forth the class III summary.
[59 FR 64296, Dec. 14, 1994]
Sec. 807.95 Confidentiality of information.
(a) The Food and Drug Administration will disclose publicly whether
there exists a premarket notification submission under this part:
(1) Where the device is on the market, i.e., introduced or delivered
for introduction into interstate commerce for commercial distribution;
(2) Where the person submitting the premarket notification
submission has disclosed, through advertising or any other manner, his
intent to market the device to scientists, market analysts, exporters,
or other individuals who are not employees of, or paid consultants to,
the establishment and who are not in an advertising or law firm pursuant
to commercial arrangements with appropriate safeguards for secrecy; or
(3) Where the device is not on the market and the intent to market
the device has not been so disclosed, except where the submission is
subject to an exception under paragraph (b) or (c) of this section.
(b) The Food and Drug Administration will not disclose publicly the
existence of a premarket notification submission for a device that is
not on the market and where the intent to market the device has not been
disclosed for 90 days from the date of receipt of the submission, if:
(1) The person submitting the premarket notification submission
requests in the submission that the Food and Drug Administration hold as
confidential commercial information the intent to market the device and
submits a certification to the Commissioner:
(i) That the person considers his intent to market the device to be
confidential commercial information;
(ii) That neither the person nor, to the best of his knowledge,
anyone else, has disclosed through advertising or any other manner, his
intent to market the device to scientists, market analysts, exporters,
or other individuals, except employees of, or paid consultants to, the
establishment or individuals in an advertising or law firm pursuant to
commercial arrangements with appropriate safeguards for secrecy;
(iii) That the person will immediately notify the Food and Drug
Administration if he discloses the intent to market the device to
anyone, except employees of, or paid consultants to, the establishment
or individuals in an advertising or law firm pursuant to commercial
arrangements with appropriate safeguards for secrecy;
(iv) That the person has taken precautions to protect the
confidentiality of the intent to market the device; and
(v) That the person understands that the submission to the
government of false information is prohibited by 18 U.S.C. 1001 and 21
U.S.C. 331(q); and
(2) The Commissioner agrees that the intent to market the device is
confidential commercial information.
(c) Where the Commissioner determines that the person has complied
with the procedures described in paragraph (b) of this section with
respect to a device that is not on the market and where the intent to
market the device has not been disclosed, and the Commissioner agrees
that the intent to market the device is confidential commercial
information, the Commissioner will not disclose the existence of the
submission for 90 days from the date of its receipt by the agency. In
addition, the Commissioner will continue not to disclose the existence
of such a submission for the device for an additional time when any of
the following occurs:
(1) The Commissioner requests in writing additional information
regarding the device pursuant to Sec. 807.87(h), in which case the
Commissioner will not disclose the existence of the submission until 90
days after the Food and Drug Administration's receipt of a complete
premarket notification submission;
[[Page 88]]
(2) The Commissioner determines that the device intended to be
introduced is a class III device and cannot be marketed without
premarket approval or reclassification, in which case the Commissioner
will not disclose the existence of the submission unless a petition for
reclassification is submitted under section 513(f)(2) of the act and its
existence can be disclosed under Sec. 860.5(d) of this chapter; or
(d) FDA will make a 510(k) summary of the safety and effectiveness
data available to the public within 30 days of the issuance of a
determination that the device is substantially equivalent to another
device. Accordingly, even when a 510(k) submitter has complied with the
conditions set forth in paragraphs (b) and (c) of this section,
confidentiality for a premarket notification submission cannot be
granted beyond 30 days after FDA issues a determination of equivalency.
(e) Data or information submitted with, or incorporated by reference
in, a premarket notification submission (other than safety and
effectiveness data that have not been disclosed to the public) shall be
available for disclosure by the Food and Drug Administration when the
intent to market the device is no longer confidential in accordance with
this section, unless exempt from public disclosure in accordance with
part 20 of this chapter. Upon final classification, data and information
relating to safety and effectiveness of a device classified in class I
(general controls) or class II (performance standards) shall be
available for public disclosure. Data and information relating to safety
and effectiveness of a device classified in class III (premarket
approval) that have not been released to the public shall be retained as
confidential unless such data and information become available for
release to the public under Sec. 860.5(d) or other provisions of this
chapter.
[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 57
FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994; 84 FR 68339, Dec.
16, 2019]
Sec. 807.97 Misbranding by reference to premarket notification.
Submission of a premarket notification in accordance with this
subpart, and a subsequent determination by the Commissioner that the
device intended for introduction into commercial distribution is
substantially equivalent to a device in commercial distribution before
May 28, 1976, or is substantially equivalent to a device introduced into
commercial distribution after May 28, 1976, that has subsequently been
reclassified into class I or II, does not in any way denote official
approval of the device. Any representation that creates an impression of
official approval of a device because of complying with the premarket
notification regulations is misleading and constitutes misbranding.
Sec. 807.100 FDA action on a premarket notification.
(a) After review of a premarket notification, FDA will:
(1) Issue an order declaring the device to be substantially
equivalent to a legally marketed predicate device;
(2) Issue an order declaring the device to be not substantially
equivalent to any legally marketed predicate device;
(3) Request additional information; or
(4) Withhold the decision until a certification or disclosure
statement is submitted to FDA under part 54 of this chapter.
(5) Advise the applicant that the premarket notification is not
required. Until the applicant receives an order declaring a device
substantially equivalent, the applicant may not proceed to market the
device.
(b) FDA will determine that a device is substantially equivalent to
a predicate device using the following criteria:
(1) The device has the same intended use as the predicate device;
and
(2) The device:
(i) Has the same technological characteristics as the predicate
device; or
(ii)(A) Has different technological characteristics, such as a
significant change in the materials, design, energy source, or other
features of the device from those of the predicate device;
(B) The data submitted establishes that the device is substantially
equivalent to the predicate device and contains information, including
clinical
[[Page 89]]
data if deemed necessary by the Commissioner, that demonstrates that the
device is as safe and as effective as a legally marketed device; and
(C) Does not raise different questions of safety and effectiveness
than the predicate device.
(3) The predicate device has not been removed from the market at the
initiative of the Commissioner of Food and Drugs or has not been
determined to be misbranded or adulterated by a judicial order.
[57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]
PART 808_EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL
MEDICAL DEVICE REQUIREMENTS--Table of Contents
Subpart A_General Provisions
Sec.
808.1 Scope.
808.3 Definitions.
808.5 Advisory opinions.
Subpart B_Exemption Procedures
808.20 Application.
808.25 Procedures for processing an application.
808.35 Revocation of an exemption.
Subpart C_Listing of Specific State and Local Exemptions
808.53 Arizona.
808.55 California
808.57 Connecticut.
808.59 Florida.
808.61 Hawaii.
808.67 Kentucky.
808.69 Maine.
808.71 Massachusetts.
808.73 Minnesota.
808.74 Mississippi.
808.77 Nebraska.
808.80 New Jersey.
808.81 New Mexico.
808.82 New York.
808.85 Ohio.
808.87 Oregon.
808.88 Pennsylvania.
808.89 Rhode Island.
808.93 Texas.
808.97 Washington.
808.98 West Virginia.
808.101 District of Columbia.
Authority: 21 U.S.C. 360j, 360k, 371.
Source: 43 FR 18665, May 2, 1978, unless otherwise noted.
Subpart A_General Provisions
Sec. 808.1 Scope.
(a) This part prescribes procedures for the submission, review, and
approval of applications for exemption from Federal preemption of State
and local requirements applicable to medical devices under section 521
of the act.
(b) Section 521(a) of the act contains special provisions governing
the regulation of devices by States and localities. That section
prescribes a general rule that after May 28, 1976, no State or political
subdivision of a State may establish or continue in effect any
requirement with respect to a medical device intended for human use
having the force and effect of law (whether established by statute,
ordinance, regulation, or court decision), which is different from, or
in addition to, any requirement applicable to such device under any
provision of the act and which relates to the safety or effectiveness of
the device or to any other matter included in a requirement applicable
to the device under the act.
(c) Section 521(b) of the act contains a provision whereby the
Commissioner of Food and Drugs may, upon application by a State or
political subdivision, allow imposition of a requirement which is
different from, or in addition to, any requirement applicable under the
act to the device (and which is thereby preempted) by promulgating a
regulation in accordance with this part exempting the State or local
requirement from preemption. The granting of an exemption does not
affect the applicability to the device of any requirements under the
act. The Commissioner may promulgate an exemption regulation for the
preempted requirement if he makes either of the following findings:
(1) That the requirement is more stringent than a requirement under
the act applicable to the device; or
(2) That the requirement is required by compelling local conditions
and compliance with the requirement would not cause the device to be in
violation of any applicable requirement under the act.
(d) State or local requirements are preempted only when the Food and
[[Page 90]]
Drug Administration has established specific counterpart regulations or
there are other specific requirements applicable to a particular device
under the act, thereby making any existing divergent State or local
requirements applicable to the device different from, or in addition to,
the specific Food and Drug Administration requirements. There are other
State or local requirements that affect devices that are not preempted
by section 521(a) of the act because they are not ``requirements
applicable to a device'' within the meaning of section 521(a) of the
act. The following are examples of State or local requirements that are
not regarded as preempted by section 521 of the act:
(1) Section 521(a) does not preempt State or local requirements of
general applicability where the purpose of the requirement relates
either to other products in addition to devices (e.g., requirements such
as general electrical codes, and the Uniform Commercial Code (warranty
of fitness)), or to unfair trade practices in which the requirements are
not limited to devices.
(2) Section 521(a) does not preempt State or local requirements that
are equal to, or substantially identical to, requirements imposed by or
under the act.
(3) Section 521(a) does not preempt State or local permits,
licensing, registration, certification, or other requirements relating
to the approval or sanction of the practice of medicine, dentistry,
optometry, pharmacy, nursing, podiatry, or any other of the healing arts
or allied medical sciences or related professions or occupations that
administer, dispense, or sell devices. However, regulations issued under
section 520(e) or (g) of the act may impose restrictions on the sale,
distribution, or use of a device beyond those prescribed in State or
local requirements. If there is a conflict between such restrictions and
State or local requirements, the Federal regulations shall prevail.
(4) Section 521(a) does not preempt specifications in contracts
entered into by States or localities for procurement of devices.
(5) Section 521(a) does not preempt criteria for payment of State or
local obligations under Medicaid and similar Federal, State or local
health-care programs.
(6)(i) Section 521(a) does not preempt State or local requirements
respecting general enforcement, e.g., requirements that State inspection
be permitted of factory records concerning all devices, registration,
and licensing requirements for manufacturers and others, and prohibition
of manufacture of devices in unlicensed establishments. However, Federal
regulations issued under sections 519 and 520(f) of the act may impose
requirements for records and reports and good manufacturing practices
beyond those prescribed in State or local requirements. If there is a
conflict between such regulations and State or local requirements, the
Federal regulations shall prevail.
(ii) Generally, section 521(a) does not preempt a State or local
requirement prohibiting the manufacture of adulterated or misbranded
devices. Where, however, such a prohibition has the effect of
establishing a substantive requirement for a specific device, e.g., a
specific labeling requirement, then the prohibition will be preempted if
the requirement is different from, or in addition to, a Federal
requirement established under the act. In determining whether such a
requirement is preempted, the determinative factor is how the
requirement is interpreted and enforced by the State or local government
and not the literal language of the statute, which may be identical to a
provision in the act.
(7) Section 521(a) does not preempt State or local provisions
respecting delegations of authority and related administrative matters
relating to devices.
(8) Section 521(a) does not preempt a State or local requirement
whose sole purpose is raising revenue or charging fees for services,
registration, or regulatory programs.
(9) Section 521(a) does not preempt State or local requirements of
the types that have been developed under the Atomic Energy Act of 1954
(42 U.S.C. 2011 note), as amended, Subchapter C--Electronic Product
Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly
the
[[Page 91]]
Radiation Control for Health and Safety Act of 1968), and other Federal
statutes, until such time as the Food and Drug Administration issues
specific requirements under the Federal Food, Drug, and Cosmetic Act
applicable to these types of devices.
(10) Part 820 of this chapter (21 CFR part 820) (CGMP requirements)
does not preempt remedies created by States or Territories of the United
States, the District of Columbia, or the Commonwealth of Puerto Rico.
(e) It is the responsibility of the Food and Drug Administration,
subject to review by Federal courts, to determine whether a State or
local requirement is equal to, or substantially identical to,
requirements imposed by or under the act, or is different from, or in
addition to, such requirements, in accordance with the procedures
provided by this part. However, it is the responsibility of States and
political subdivisions to determine initially whether to seek exemptions
from preemption. Any State or political subdivision whose requirements
relating to devices are preempted by section 521(a) may petition the
Commissioner of Food and Drugs for exemption from preemption, in
accordance with the procedures provided by this part.
(f) The Federal requirement with respect to a device applies whether
or not a corresponding State or local requirement is preempted or
exempted from preemption. As a result, if a State or local requirement
that the Food and Drug Administration has exempted from preemption is
not as broad in its application as the Federal requirement, the Federal
requirement applies to all circumstances not covered by the State or
local requirement.
[43 FR 18665, May 2, 1978, as amended at 45 FR 67336, Oct. 10, 1980; 61
FR 52654, Oct. 7, 1996; 73 FR 34859, June 19, 2008]
Sec. 808.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Compelling local conditions includes any factors,
considerations, or circumstances prevailing in, or characteristic of,
the geographic area or population of the State or political subdivision
that justify exemption from preemption.
(c) More stringent refers to a requirement of greater
restrictiveness or one that is expected to afford to those who may be
exposed to a risk of injury from a device a higher degree of protection
than is afforded by a requirement applicable to the device under the
act.
(d) Political subdivision or locality means any lawfully established
local governmental unit within a State which unit has the authority to
establish or continue in effect any requirement having the force and
effect of law with respect to a device intended for human use.
(e) State means a State, American Samoa, the Canal Zone, the
Commonwealth of Puerto Rico, the District of Columbia, Guam, Johnston
Island, Kingman Reef, Midway Island, the Trust Territory of the Pacific
Islands, the Virgin Islands, and Wake Island.
(f) Substantially identical to refers to the fact that a State or
local requirement does not significantly differ in effect from a Federal
requirement.
Sec. 808.5 Advisory opinions.
(a) Any State, political subdivision, or other interested person may
request an advisory opinion from the Commissioner with respect to any
general matter concerning preemption of State or local device
requirements or with respect to whether the Food and Drug Administration
regards particular State or local requirements, or proposed
requirements, as preempted.
(1) Such an advisory opinion may be requested and may be granted in
accordance with Sec. 10.85 of this chapter.
(2) The Food and Drug Administration, in its discretion and after
consultation with the State or political subdivision, may treat a
request by a State or political subdivision for an advisory opinion as
an application for exemption from preemption under Sec. 808.20.
(b) The Commissioner may issue an advisory opinion relating to a
State or local requirement on his own initiative when he makes one of
the following determinations:
(1) A requirement with respect to a device for which an application
for exemption from preemption has been submitted under Sec. 808.20 is
not preempted by section 521(a) of the act because it
[[Page 92]]
is: (i) Equal to or substantially identical to a requirement under the
act applicable to the device, or (ii) is not a requirement within the
meaning of section 521 of the act and therefore is not preempted;
(2) A proposed State or local requirement with respect to a device
is not eligible for exemption from preemption because the State or local
requirement has not been issued in final form. In such a case, the
advisory opinion may indicate whether the proposed requirement would be
preempted and, if it would be preempted, whether the Food and Drug
Administration would propose to grant an exemption from preemption;
(3) Issuance of such an advisory opinion is in the public interest.
Subpart B_Exemption Procedures
Sec. 808.20 Application.
(a) Any State or political subdivision may apply to the Food and
Drug Administration for an exemption from preemption for any requirement
that it has enacted and that is preempted. An exemption may only be
granted for a requirement that has been enacted, promulgated, or issued
in final form by the authorized body or official of the State or
political subdivision so as to have the force and effect of law.
However, an application for exemption may be submitted before the
effective date of the requirement.
(b) An application for exemption shall be in the form of a letter to
the Commissioner of Food and Drugs and shall be signed by an individual
who is authorized to request the exemption on behalf of the State or
political subdivision. An original and two copies of the letter and any
accompanying material, as well as any subsequent reports or
correspondence concerning an application, shall be submitted to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The outside wrapper of
any application, report, or correspondence should indicate that it
concerns an application for exemption from preemption of device
requirements.
(c) For each requirement for which an exemption is sought, the
application shall include the following information to the fullest
extent possible, or an explanation of why such information has not been
included:
(1) Identification and a current copy of any statute, rule,
regulation, or ordinance of the State or political subdivision
considered by the State or political subdivision to be a requirement
which is preempted, with a reference to the date of enactment,
promulgation, or issuance in final form. The application shall also
include, where available, copies of any legislative history or
background materials pertinent to enactment, promulgation, or issuance
of the requirement, including hearing reports or studies concerning
development or consideration of the requirement. If the requirement has
been subject to any judicial or administrative interpretations, the
State or political subdivision shall furnish copies of such judicial or
administrative interpretations.
(2) A comparison of the requirement of the State or political
subdivision and any applicable Federal requirements to show similarities
and differences.
(3) Information on the nature of the problem addressed by the
requirement of the State or political subdivision.
(4) Identification of which (or both) of the following bases is
relied upon for seeking an exemption from preemption:
(i) The requirement is more stringent than a requirement applicable
to a device under the act. If the State or political subdivision relies
upon this basis for exemption from preemption, the application shall
include information, data, or material showing how and why the
requirement of the State or political subdivision is more stringent than
requirements under the act.
(ii) The requirement is required by compelling local conditions, and
compliance with the requirement would not cause the device to be in
violation of any applicable requirement under the act. If the State or
political subdivision relies upon this basis for exemption from
preemption, the application shall include information, data, or material
showing why compliance with
[[Page 93]]
the requirement of the State or political subdivision would not cause a
device to be in violation of any applicable requirement under the act
and why the requirement is required by compelling local conditions. The
application shall also explain in detail the compelling local conditions
that justify the requirement.
(5) The title of the chief administrative or legal officers of that
State or local agency that has primary responsibility for administration
of the requirement.
(6) When requested by the Food and Drug Administration, any records
concerning administration of any requirement which is the subject of an
exemption or an application for an exemption from preemption.
(7) Information on how the public health may be benefitted and how
interstate commerce may be affected, if an exemption is granted.
(8) Any other pertinent information respecting the requirement
voluntarily submitted by the applicant.
(d) If litigation regarding applicability of the requirement is
pending, the State or political subdivision may so indicate in its
application and request expedited action on such application.
[43 FR 18665, May 2, 1978; 43 FR 22010, May 23, 1978, as amended at 49
FR 3646, Jan. 30, 1984; 59 FR 14365, Mar. 28, 1994]
Sec. 808.25 Procedures for processing an application.
(a) Upon receipt of an application for an exemption from preemption
submitted in accordance with Sec. 808.20, the Commissioner shall notify
the State or political subdivision of the date of such receipt.
(b) If the Commissioner finds that an application does not meet the
requirements of Sec. 808.20, he shall notify the State or political
subdivision of the deficiencies in the application and of the
opportunity to correct such deficiencies. A deficient application may be
corrected at any time.
(c) After receipt of an application meeting the requirements of
Sec. 808.20, the Commissioner shall review such application and
determine whether to grant or deny an exemption from preemption for each
requirement which is the subject of the application. The Commissioner
shall then issue in the Federal Register a proposed regulation either to
grant or to deny an exemption from preemption. The Commissioner shall
also issue in the Federal Register a notice of opportunity to request an
oral hearing before the Commissioner or the Commissioner's designee.
(d) A request for an oral hearing may be made by the State or
political subdivision or any other interested person. Such request shall
be submitted to the Division of Dockets Management within the period of
time prescribed in the notice and shall include an explanation of why an
oral hearing, rather than submission of written comments only, is
essential to the presentation of views on the application for exemption
from preemption and the proposed regulation.
(e) If a timely request for an oral hearing is made, the
Commissioner shall review such a request and may grant a legislative-
type informal oral hearing pursuant to part 15 of this chapter by
publishing in the Federal Register a notice of the hearing in accordance
with Sec. 15.20 of this chapter. The scope of the oral hearing shall be
limited to matters relevant to the application for exemption from
preemption and the proposed regulation. Oral or written presentations at
the oral hearing which are not relevant to the application shall be
excluded from the administrative record of the hearing.
(f) If a request for hearing is not timely made or a notice of
appearance is not filed pursuant to Sec. 15.21 of this chapter, the
Commissioner shall consider all written comments submitted and publish a
final rule in accordance with paragraph (g) of this section.
(g)(1) The Commissioner shall review all written comments submitted
on the proposed rule and the administrative record of the oral hearing,
if an oral hearing has been granted, and shall publish in the Federal
Register a final rule in subpart C of this part identifying any
requirement in the application for which exemption from preemption is
granted, or conditionally granted, and any requirement in the
application for which exemption from preemption is not granted.
[[Page 94]]
(2) The Commissioner may issue a regulation granting or
conditionally granting an application for an exemption from preemption
for any requirement if the Commissioner makes either of the following
findings:
(i) The requirement is more stringent than a requirement applicable
to the device under the act;
(ii) The requirement is required by compelling local conditions, and
compliance with the requirement would not cause the device to be in
violation of any requirement applicable to the device under the act.
(3) The Commissioner may not grant an application for an exemption
from preemption for any requirement with respect to a device if the
Commissioner determines that the granting of an exemption would not be
in the best interest of public health, taking into account the potential
burden on interstate commerce.
(h) An advisory opinion pursuant to Sec. 808.5 or a regulation
pursuant to paragraph (g) of this section constitutes final agency
action.
Sec. 808.35 Revocation of an exemption.
(a) An exemption from preemption pursuant to a regulation under this
part shall remain effective until the Commissioner revokes such
exemption.
(b) The Commissioner may by regulation, in accordance with Sec.
808.25, revoke an exemption from preemption for any of the following
reasons:
(1) An exemption may be revoked upon the effective date of a newly
established requirement under the act which, in the Commissioner's view,
addresses the objectives of an exempt requirement and which is
described, when issued, as preempting a previously exempt State or local
requirement.
(2) An exemption may be revoked upon a finding that there has
occurred a change in the bases listed in Sec. 808.20(c)(4) upon which
the exemption was granted.
(3) An exemption may be revoked if it is determined that a condition
placed on the exemption by the regulation under which the exemption was
granted has not been met or is no longer being met.
(4) An exemption may be revoked if a State or local jurisdiction
fails to submit records as provided in Sec. 808.20(c)(6).
(5) An exemption may be revoked if a State or local jurisdiction to
whom the exemption was originally granted requests revocation.
(6) An exemption may be revoked if it is determined that it is no
longer in the best interests of the public health to continue the
exemption.
(c) An exemption that has been revoked may be reinstated, upon
request from the State or political subdivision, if the Commissioner, in
accordance with the procedures in Sec. 808.25, determines that the
grounds for revocation are no longer applicable except that the
Commissioner may permit abbreviated submissions of the documents and
materials normally required for an application for exemption under Sec.
808.20.
Subpart C_Listing of Specific State and Local Exemptions
Sec. 808.53 Arizona.
The following Arizona medical device requirements are preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied them exemptions from preemption under section 521(b) of the act:
(a) Arizona Revised Statutes, Chapter 17, sections 36-1901.7(s) and
36-1901.7(t).
(b) Arizona Code of Revised Regulations, Title 9, Article 3,
sections R9-16-303 and R9-16-304.
[45 FR 67336, Oct. 10, 1980]
Sec. 808.55 California.
(a) The following California medical device requirements are
enforceable notwithstanding section 521 of the act because the Food and
Drug Administration exempted them from preemption under section 521(b)
of the act: Business and Professions Code sections 3365 and 3365.6.
(b) The following California medical device requirements are
preempted by section 521 of the act, and FDA has denied them an
exemption from preemption:
[[Page 95]]
(1) Sherman Food, Drug, and Cosmetic Law (Division 21 of the
California Health and Safety Code), sections 26207, 26607, 26614, 26615,
26618, 26631, 26640, and 26641, to the extent that they apply to
devices.
(2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the
extent that it applies to hearing aids.
(3) Business and Professions Code section 2541.3, to the extent that
it requires adoption of American National Standards Institute standards
Z-80.1 and Z-80.2.
[45 FR 67324, Oct. 10, 1980]
Sec. 808.57 Connecticut.
The following Connecticut medical device requirements are
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted them from preemption under section
521(b) of the act: Connecticut General Statutes, sections 20-403 and 20-
404.
[45 FR 67336, Oct. 10, 1980]
Sec. 808.59 Florida.
The following Florida medical device requirements are preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied them an exemption from preemption under section 521(b) of the
act:
(a) Florida Statutes, section 468.135(5).
(b) Florida Administrative Code, section 10D-48.25(26).
[45 FR 67336, Oct. 10, 1980]
Sec. 808.61 Hawaii.
(a) The following Hawaii medical device requirements are enforceable
notwithstanding section 521 of the act, because the Food and Drug
Administration has exempted them from preemption under section 521(b) of
the act: Hawaii Revised Statutes, chapter 451A, Sec. 14.1, subsection
(a) with respect to medical examination of a child 10 years of age or
under, and subsection (c).
(b) The following Hawaii medical device requirements are preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied them exemption from preemption: Hawaii Revised Statutes, chapter
451A, Sec. 14.1, subsection (a) to the extent that it requires a
written authorization by a physician and does not allow adults to waive
this requirement for personal, as well as religious reasons, and
subsection (b).
[50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985]
Sec. 808.67 Kentucky.
The following Kentucky medical device requirement is preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Kentucky Revised Statutes, section 334.200(1).
[45 FR 67336, Oct. 10, 1980]
Sec. 808.69 Maine.
(a) The following Maine medical device requirement is enforceable
notwithstanding section 521(a) of the act because the Food and Drug
Administration has exempted it from preemption under section 521(b) of
the act: Maine Revised Statutes Annotated, Title 32, section 1658-C, on
the condition that, in enforcing this requirement, Maine apply the
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this
chapter.
(b) The following Maine medical device requirement is preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Maine Revised Statutes Annotated, Title 32, section 1658-D and the last
sentence of section 1658-E.
[45 FR 67336, Oct. 10, 1980]
Sec. 808.71 Massachusetts.
(a) The following Massachusetts medical device requirements are
enforceable notwithstanding section 521 of the act because the Food and
Drug Administration has exempted them from preemption under section
521(b) of the act:
(1) Massachusetts General Laws, Chapter 93, Section 72, to the
extent that it requires a hearing test evaluation for a child under the
age of 18.
(2) Massachusetts General Laws, Chapter 93, Section 74, except as
provided in paragraph (6) of the Section, on the condition that, in
enforcing this requirement, Massachusetts apply the
[[Page 96]]
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this
chapter.
(b) The following Massachusetts medical device requirements are
preempted by section 521(a) of the act, and the Food and Drug
Administration has denied them exemptions from preemption under section
521(b) of the act.
(1) Massachusetts General Laws, Chapter 93, Section 72, except as
provided in paragraph (a) of this section.
(2) Massachusetts General Laws, Chapter 93, Section 74, to the
extent that it requires that the sales receipt contain a statement that
State law requires a medical examination and a hearing test evaluation
before the sale of a hearing aid.
[45 FR 67326, Oct. 10, 1980]
Sec. 808.73 Minnesota.
The following Minnesota medical device requirements are preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied them an exemption from preemption under section 521(b) of the
act: Minnesota Statutes, sections 145.43 and 145.44.
[45 FR 67336, Oct. 10, 1980]
Sec. 808.74 Mississippi.
The following Mississippi medical device requirement is preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Mississippi Code, section 73-14-3(g)(9).
[45 FR 67336, Oct. 10, 1980]
Sec. 808.77 Nebraska.
(a) The following Nebraska medical device requirement is enforceable
notwithstanding section 521(a) of the act because the Food and Drug
Administration has exempted it from preemption under section 521(b) of
the act: Nebraska Revised Statutes, section 71-4712(2)(c)(vi).
(b) The following Nebraska medical device requirement is preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Nebraska Revised Statutes, section 71-4712(2)(c)(vii).
[45 FR 67336, Oct. 10, 1980]
Sec. 808.80 New Jersey.
(a) The following New Jersey medical device requirements are
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted them from preemption under section
521(b) of the act:
(1) New Jersey Statutes Annotated, section 45:9A-23 on the condition
that, in enforcing this requirement, New Jersey apply the definition of
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter;
(2) New Jersey Statutes Annotated, sections 45:9A-24 and 45:9A-25;
(3) Chapter 3, Section 5 of the Rules and Regulations adopted
pursuant to New Jersey Statutes Annotated 45:9A-1 et seq. except as
provided in paragraph (b) of this section.
(b) The following New Jersey medical device requirement is preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Chapter 3, Section 5 of the Rules and Regulations adopted pursuant to
New Jersey Statutes Annotated 45:9A-1 et seq. to the extent that it
requires testing to be conducted in an environment which meets or
exceeds the American National Standards Institute S3.1 Standard.
[45 FR 67337, Oct. 10, 1980]
Sec. 808.81 New Mexico.
The following New Mexico medical device requirement is enforceable
notwithstanding section 521(a) of the act because the Food and Drug
Administration has exempted it from preemption under section 521(b) of
the act: New Mexico Statutes Annotated, section 67-36-16(F).
[45 FR 67337, Oct. 10, 1980]
Sec. 808.82 New York.
(a) The following New York medical device requirements are
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted them from preemption under section
521(b) of the act:
[[Page 97]]
(1) General Business Law, Article 37, sections 784(3) and (4).
(2) Official Compilation of Codes, Rules and Regulations of the
State of New York, Chapter V, Title 19, Subchapter G, section 191.10 and
section 191.11(a) on the condition that, in enforcing these
requirements, New York apply the definition of ``used hearing aid'' in
Sec. 801.420(a)(6) of this chapter and section 191.11(b), (c), (d), and
(e).
(b) The following New York medical device requirements are preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied them an exemptions from preemption under section 521(b) of the
act:
(1) General Business Law, Article 37, section 784.1.
(2) Official Compilation of Codes, Rules and Regulations of the
State of New York, Chapter V, Title 19, Subchapter G, sections 191.6,
191.7, 191.8, and 191.9.
[45 FR 67337, Oct. 10, 1980]
Sec. 808.85 Ohio.
(a) The following Ohio medical device requirement is enforceable
notwithstanding section 521(a) of the act because the Food and Drug
Administration has exempted it from preemption under section 521(b) of
the act: Ohio Revised Code, section 4747.09, the first two sentences
with respect to disclosure of information to purchasers on the condition
that, in enforcing these requirements, Ohio apply the definition of
``used hearing aid'' in Sec. 801.420(a)(6) of this chapter.
(b) The following Ohio medical device requirement is preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Ohio Revised Code, section 4747.09, the last two sentences with respect
to medical examination of children.
[45 FR 67337, Oct. 10, 1980]
Sec. 808.87 Oregon.
(a) The following Oregon medical device requriements are enforceable
notwithstanding section 521(a) of the act because the Food and Drug
Administration has exempted them from preemption under section 521(b) of
the act: Oregon Revised Statutes, section 694.036 on the condition that,
in enforcing this requirement, Oregon apply the definition of ``used
hearing aid'' in Sec. 801.420(a)(6) of this chapter.
(b) The following Oregon medical device requirements are preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied them exemptions from preemption under section 521(b) of the act:
Oregon Revised Statutes, sections 694.136(6) and (7).
[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 11252, Apr. 6, 1988]
Sec. 808.88 Pennsylvania.
(a) The following Pennsylvania medical device requirements are
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted them from preemption under section
521(b) of the act: 35 Purdon's Statutes 6700, section 504(4) on the
condition that, in enforcing this requirement, Pennsylvania apply the
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this
chapter; section 506; and, section 507(2).
(b) The following Pennsylvania medical device requirement is
preempted by section 521(a) of the act and the Food and Drug
Administration has denied it an exemption from preemption under section
521(b) of the act: 35 Purdon's Statutes 6700, section 402.
[45 FR 67326, Oct. 10, 1980]
Sec. 808.89 Rhode Island.
The following Rhode Island medical device requirements are preempted
by section 521(a) of the act, and the Food and Drug Administration has
denied them an exemption from preemption under section 521(b) of the
act: Rhode Island General Laws, Section 5-49-2.1, and Section 2.2, to
the extent that Section 2.2 requires hearing aid dispensers to keep
copies of the certificates of need.
[45 FR 67337, Oct. 10, 1980]
Sec. 808.93 Texas.
(a) The following Texas medical device requirement is enforceable
notwithstanding section 521(a) of the act
[[Page 98]]
because the Food and Drug Administration has exempted it from preemption
under section 521(b) of the act: Vernon's Civil Statutes, Article 4566,
section 14(b) on the condition that, in enforcing this requirement,
Texas apply the definition of ``used hearing aid'' in Sec.
801.420(a)(6) of this chapter.
(b) The following Texas medical device requirement is preempted by
section 521(a) of the act, and the Food and Drug Administration has
denied it an exemption from preemption under section 521(b) of the act:
Vernon's Civil Statutes, Article 4566, section 14(d).
[45 FR 67337, Oct. 10, 1980]
Sec. 808.97 Washington.
(a) The following Washington medical device requirement is
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted it from preemption under section
521(b) of the act: Revised Code of Washington 18.35.110(2)(e) (i) and
(iii) on the condition that it is enforced in addition to the applicable
requirements of this chapter.
(b) The following Washington medical device requirements are
preempted by section 521(a) of the act, and the Food and Drug
Administration has denied them an exemption from preemption under
section 521(b) of the act: Revised Code of Washington
18.35.110(2)(e)(ii).
[45 FR 67337, Oct. 10, 1980]
Sec. 808.98 West Virginia.
(a) The following West Virginia medical device requirements are
enforceable notwithstanding section 521(a) of the act because the Food
and Drug Administration has exempted them from preemption: West Virginia
Code, sections 30-26-14 (b) and (c) and section 30-26-15(a) on the
condition that in enforcing section 30-26-15(a) West Virginia apply the
definition of ``used hearing aid'' in Sec. 801.420(a)(6) of this
chapter.
(b) The following West Virginia medical device requirement is
preempted by section 521(a) of the act, and the Food and Drug
Administration has denied it an exemption from preemption under section
521(b) of the act: West Virginia Code, section 30-26-14(a).
[45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988]
Sec. 808.101 District of Columbia.
(a) The following District of Columbia medical device requirements
are enforceable, notwithstanding section 521 of the act, because the
Food and Drug Administration has exempted them from preemption under
section 521(b) of the act:
(1) Act 2-79, section 5, to the extent that it requires an
audiological evaluation for children under the age of 18.
(2) Act 2-79, section 6, on the condition that in enforcing section
6(a)(5), the District of Columbia apply the definition of ``used hearing
aid'' in Sec. 801.420(a)(6) of this chapter.
(b) The following District of Columbia medical device requirement is
preempted by section 521(a) of the act, and the Food and Drug
Administration has denied it an exemption from preemption under section
521(b) of the act: Act 2-79, section 5, except as provided in paragraph
(a) of this section.
[46 FR 59236, Dec. 4, 1981]
PART 809_IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE--Table of Contents
Subpart A_General Provisions
Sec.
809.3 Definitions.
809.4 Confidentiality of submitted information.
Subpart B_Labeling
809.10 Labeling for in vitro diagnostic products.
809.11 Exceptions or alternatives to labeling requirements for in vitro
diagnostic products for human use held by the Strategic
National Stockpile.
Subpart C_Requirements for Manufacturers and Producers
809.20 General requirements for manufacturers and producers of in vitro
diagnostic products.
809.30 Restrictions on the sale, distribution and use of analyte
specific reagents.
809.40 Restrictions on the sale, distribution, and use of OTC test
sample collection systems for drugs of abuse testing.
[[Page 99]]
Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h,
360i, 360j, 371, 372, 374, 381.
Subpart A_General Provisions
Sec. 809.3 Definitions.
(a) In vitro diagnostic products are those reagents, instruments,
and systems intended for use in the diagnosis of disease or other
conditions, including a determination of the state of health, in order
to cure, mitigate, treat, or prevent disease or its sequelae. Such
products are intended for use in the collection, preparation, and
examination of specimens taken from the human body. These products are
devices as defined in section 201(h) of the Federal Food, Drug, and
Cosmetic Act (the act), and may also be biological products subject to
section 351 of the Public Health Service Act.
(b) A product class is all those products intended for use for a
particular determination or for a related group of determinations or
products with common or related characteristics or those intended for
common or related uses. A class may be further divided into subclasses
when appropriate.
(c) [Reserved]
(d) Act means the Federal Food, Drug, and Cosmetic Act.
[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]
Sec. 809.4 Confidentiality of submitted information.
Data and information submitted under Sec. 809.10(c) that are shown
to fall within the exemption established in Sec. 20.61 of this chapter
shall be treated as confidential by the Food and Drug Administration and
any person to whom the data and information are referred. The Food and
Drug Administration will determine whether information submitted will be
treated as confidential in accordance with the provisions of part 20 of
this chapter.
[45 FR 7484, Feb. 1, 1980]
Subpart B_Labeling
Sec. 809.10 Labeling for in vitro diagnostic products.
(a) The label for an in vitro diagnostic product shall state the
following information, except where such information is not applicable,
or as otherwise specified in a standard for a particular product class
or as provided in paragraph (e) of this section. Section 201(k) of the
act provides that ``a requirement made by or under authority of this act
that any word, statement, or other information appear on the label shall
not be considered to be complied with unless such word, statement, or
other information also appears on the outside container or wrapper, if
any there be, of the retail package of such article, or is easily
legible through the outside container or wrapper.''
(1) The proprietary name and established name (common or usual
name), if any.
(2) The intended use or uses of the product.
(3) For a reagent, a declaration of the established name (common or
usual name), if any, and quantity, proportion or concentration of each
reactive ingredient; and for a reagent derived from biological material,
the source and a measure of its activity. The quantity, proportion,
concentration, or activity shall be stated in the system generally used
and recognized by the intended user, e.g., metric, international units,
etc.
(4) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR part 1500 and any other warnings
appropriate to the hazard presented by the product; and a statement
``For In Vitro Diagnostic Use'' and any other limiting statements
appropriate to the intended use of the product. The limiting statement
appropriate to the intended use of a prescription in vitro diagnostic
product shall bear the symbol statement ``Rx only'' or ``[rx] only'' or
the statement ``Caution: Federal law restricts this device to sale by or
on the order of a ___'', the blank to be filled with the word
``physician'', ``dentist'', ``veterinarian'', or with the descriptive
designation of any other practitioner licensed by the law of the State
in which the practitioner practices to use or order the use of the
device.
(5) For a reagent, appropriate storage instructions adequate to
protect the
[[Page 100]]
stability of the product. When applicable, these instructions shall
include such information as conditions of temperature, light, humidity,
and other pertinent factors. For products requiring manipulation, such
as reconstitution and/or mixing before use, appropriate storage
instructions shall be provided for the reconstituted or mixed product
which is to be stored in the original container. The basis for such
instructions shall be determined by reliable, meaningful, and specific
test methods such as those described in Sec. 211.166 of this chapter.
(6) For a reagent, a means by which the user may be assured that the
product meets appropriate standards of identity, strength, quality and
purity at the time of use. This shall be provided, both for the product
as provided and for any resultant reconstituted or mixed product, by
including on the label one or more of the following:
(i) An expiration date based upon the stated storage instructions.
(ii) A statement of an observable indication of an alteration of the
product, e.g., turbidity, color change, precipitate, beyond its
appropriate standards.
(iii) Instructions for a simple method by which the user can
reasonably determine that the product meets its appropriate standards.
(7) For a reagent, a declaration of the net quantity of contents,
expressed in terms of weight or volume, numerical count, or any
combination of these or other terms which accurately reflect the
contents of the package. The use of metric designations is encouraged,
wherever appropriate. If more than a single determination may be
performed using the product, any statement of the number of tests shall
be consistent with instructions for use and amount of material provided.
(8) Name and place of business of manufacturer, packer, or
distributor.
(9) A lot or control number, identified as such, from which it is
possible to determine the complete manufacturing history of the product.
(i) If it is a multiple unit product, the lot or control number
shall permit tracing the identity of the individual units.
(ii) For an instrument, the lot or control number shall permit
tracing the identity of all functional subassemblies.
(iii) For multiple unit products which require the use of included
units together as a system, all units should bear the same lot or
control number, if appropriate, or other suitable uniform identification
should be used.
(10) Except that for items in paragraphs (a) (1) through (9) of this
section: (i) In the case of immediate containers too small or otherwise
unable to accommodate a label with sufficient space to bear all such
information and which are packaged within an outer container from which
they are removed for use, the information required by paragraphs (a)
(2), (3), (4), (5), (6) (ii), (iii) and (7) of this section may appear
in the outer container labeling only.
(ii) In any case in which the presence of this information on the
immediate container will interfere with the test, the information may
appear on the outside container or wrapper rather than on the immediate
container label.
(b) Labeling accompanying each product, e.g., a package insert,
shall state in one place the following information in the format and
order specified below, except where such information is not applicable,
or as specified in a standard for a particular product class. The
labeling for a multiple-purpose instrument used for diagnostic purposes,
and not committed to specific diagnostic procedures or systems, may bear
only the information indicated in paragraphs (b) (1), (2), (6), (14),
and (15) of this section. The labeling for a reagent intended for use as
a replacement in a diagnostic system may be limited to that information
necessary to identify the reagent adequately and to describe its proper
use in the system.
(1) The proprietary name and established name, i.e., common or usual
name, if any.
(2) The intended use or uses of the product and the type of
procedure, e.g., qualitative or quantitative.
(3) Summary and explanation of the test. Include a short history of
the methodology, with pertinent references and a balanced statement of
the special merits and limitations of this method
[[Page 101]]
or product. If the product labeling refers to any other procedure,
appropriate literature citations shall be included and the labeling
shall explain the nature of any differences from the original and their
effect on the results.
(4) The chemical, physical, physiological, or biological principles
of the procedure. Explain concisely, with chemical reactions and
techniques involved, if applicable.
(5) Reagents:
(i) A declaration of the established name (common or usual name), if
any, and quantity, proportion or concentration or each reactive
ingredient; and for biological material, the source and a measure of its
activity. The quantity, proportion, concentration or activity shall be
stated in the system generally used and recognized by the intended user,
e.g., metric, international units, etc. A statement indicating the
presence of and characterizing any catalytic or nonreactive ingredients,
e.g., buffers, preservatives, stabilizers.
(ii) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR part 1500 and any other warnings
appropriate to the hazard presented by the product; and a statement
``For In Vitro Diagnostic Use'' and any other limiting statements
appropriate to the intended use of the product. The limiting statement
appropriate to the intended use of a prescription in vitro diagnostic
product shall bear the symbol statement ``Rx only'' or ``[rx] only'' or
the statement ``Caution: Federal law restricts this device to sale by or
on the order of a ___'', the blank to be filled with the word
``physician'', ``dentist'', ``veterinarian'', or with the descriptive
designation of any other practitioner licensed by the law of the State
in which the practitioner practices to use or order the use of the
device.
(iii) Adequate instructions for reconstitution, mixing, dilution,
etc.
(iv) Appropriate storage instructions adequate to protect the
stability of the product. When applicable, these instructions shall
include such information as conditions of temperature, light, humidity,
and other pertinent factors. For products requiring manipulation, such
as reconstitution and/or mixing before use, appropriate storage
instructions shall be provided for the reconstituted or mixed product.
The basis for such instructions shall be determined by reliable,
meaningful, and specific test methods such as those described in Sec.
211.166 of this chapter.
(v) A statement of any purification or treatment required for use.
(vi) Physical, biological, or chemical indications of instability or
deterioration.
(6) Instruments:
(i) Use or function.
(ii) Installation procedures and special requirements.
(iii) Principles of operation.
(iv) Performance characteristics and specifications.
(v) Operating instructions.
(vi) Calibration procedures including materials and/or equipment to
be used.
(vii) Operational precautions and limitations.
(viii) Hazards.
(ix) Service and maintenance information.
(7) Specimen collection and preparation for analysis, including a
description of:
(i) Special precautions regarding specimen collection including
special preparation of the patient as it bears on the validity of the
test.
(ii) Additives, preservatives, etc., necessary to maintain the
integrity of the specimen.
(iii) Known interfering substances.
(iv) Recommended storage, handling or shipping instructions for the
protection and maintenance of stability of the specimen.
(8) Procedure: A step-by-step outline of recommended procedures from
reception of the specimen to obtaining results. List any points that may
be useful in improving precision and accuracy.
(i) A list of all materials provided, e.g., reagents, instruments
and equipment, with instructions for their use.
(ii) A list of all materials required but not provided. Include such
details as sizes, numbers, types, and quality.
(iii) A description of the amounts of reagents necessary, times
required for specific steps, proper temperatures, wavelengths, etc.
(iv) A statement describing the stability of the final reaction
material to
[[Page 102]]
be measured and the time within which it shall be measured to assure
accurate results.
(v) Details of calibration: Identify reference material. Describe
preparation of reference sample(s), use of blanks, preparation of the
standard curve, etc. The description of the range of calibration should
include the highest and the lowest values measurable by the procedure.
(vi) Details of kinds of quality control procedures and materials
required. If there is need for both positive and negative controls, this
should be stated. State what are considered satisfactory limits of
performance.
(9) Results: Explain the procedure for calculating the value of the
unknown. Give an explanation for each component of the formula used for
the calculation of the unknown. Include a sample calculation, step-by-
step, explaining the answer. The values shall be expressed to the
appropriate number of significant figures. If the test provides other
than quantitative results, provide an adequate description of expected
results.
(10) Limitation of the procedure: Include a statement of limitations
of the procedure. State known extrinsic factors or interfering
substances affecting results. If further testing, either more specific
or more sensitive, is indicated in all cases where certain results are
obtained, the need for the additional test shall be stated.
(11) Expected values: State the range(s) of expected values as
obtained with the product from studies of various populations. Indicate
how the range(s) was established and identify the population(s) on which
it was established.
(12) Specific performance characteristics: Include, as appropriate,
information describing such things as accuracy, precision, specificity,
and sensitivity. These shall be related to a generally accepted method
using biological specimens from normal and abnormal populations. Include
a statement summarizing the data upon which the specific performance
characteristics are based.
(13) Bibliography: Include pertinent references keyed to the text.
(14) Name and place of business of manufacturer, packer, or
distributor.
(15) Date of issuance of the last revision of the labeling
identified as such.
(c) A shipment or other delivery of an in vitro diagnostic product
shall be exempt from the requirements of paragraphs (a) and (b) of this
section and from a standard promulgated under part 861 provided that the
following conditions are met:
(1) In the case of a shipment or delivery for an investigation
subject to part 812, if there has been compliance with part 812; or
(2) In the case of a shipment or delivery for an investigation that
is not subject to part 812 (see Sec. 812.2(c)), if the following
conditions are met:
(i) For a product in the laboratory research phase of development,
and not represented as an effective in vitro diagnostic product, all
labeling bears the statement, prominently placed: ``For Research Use
Only. Not for use in diagnostic procedures.''
(ii) For a product being shipped or delivered for product testing
prior to full commercial marketing (for example, for use on specimens
derived from humans to compare the usefulness of the product with other
products or procedures which are in current use or recognized as
useful), all labeling bears the statement, prominently placed: ``For
Investigational Use Only. The performance characteristics of this
product have not been established.''
(d) The labeling of general purpose laboratory reagents (e.g.,
hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose
uses are generally known by persons trained in their use need not bear
the directions for use required by Sec. 809.10(a) and (b), if their
labeling meets the requirements of this paragraph.
(1) The label of a reagent shall bear the following information:
(i) The proprietary name and established name (common or usual
name), if any, of the reagent.
(ii) A declaration of the established name (common or usual name),
if any, and quantity, proportion or concentration of the reagent
ingredient (e.g., hydrochloric acid: Formula weight 36.46, assay 37.9
percent, specific gravity 1.192 at 60 [deg]F); and for a reagent derived
[[Page 103]]
from biological material, the source and where applicable a measure of
its activity. The quantity, proportion, concentration or activity shall
be stated in the system generally used and recognized by the intended
user, e.g., metric, international units, etc.
(iii) A statement of the purity and quality of the reagent,
including a quantitative declaration of any impurities present. The
requirement for this information may be met by a statement of conformity
with a generally recognized and generally available standard which
contains the same information, e.g., those established by the American
Chemical Society, U.S. Pharmacopeia, National Formulary, National
Research Council.
(iv) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR part 1500 and any other warnings
appropriate to the hazard presented by the product; and a statement
``For Laboratory Use.''
(v) Appropriate storage instructions adequate to protect the
stability of the product. When applicable, these instructions shall
include such information as conditions of temperature, light, humidity,
and other pertinent factors. The basis for such information shall be
determined by reliable, meaningful, and specific test methods such as
those described in Sec. 211.166 of this chapter.
(vi) A declaration of the net quantity of contents, expressed in
terms of weight or volume, numerical count, or any combination of these
or other terms which accurately reflect the contents of the package. The
use of metric designations is encouraged, wherever appropriate.
(vii) Name and place of business of manufacturer, packer, or
distributor.
(viii) A lot or control number, identified as such, from which it is
possible to determine the complete manufacturing history of the product.
(ix) In the case of immediate containers too small or otherwise
unable to accommodate a label with sufficient space to bear all such
information, and which are packaged within an outer container from which
they are removed for use, the information required by paragraphs
(d)(1)(ii), (iii), (iv), (v), and (vi) of this section may appear in the
outer container labeling only.
(2) The label of general purpose laboratory equipment, e.g., a
beaker or a pipette, shall bear a statement adequately describing the
product, its composition, and physical characteristics if necessary for
its proper use.
(e)(1) The labeling for analyte specific reagents (e.g., monoclonal
antibodies, deoxyribonucleic acid (DNA) probes, viral antigens, ligands)
shall bear the following information:
(i) The proprietary name and established name (common or usual
name), if any, of the reagent;
(ii) A declaration of the established name (common or usual name),
if any;
(iii) The quantity, proportion, or concentration of the reagent
ingredient; and for a reagent derived from biological material, the
source and where applicable, a measure of its activity. The quantity,
proportion, concentration, or activity shall be stated in the system
generally used and recognized by the intended user, e.g., metric,
international units, etc.;
(iv) A statement of the purity and quality of the reagent, including
a quantitative declaration of any impurities present and method of
analysis or characterization. The requirement for this information may
be met by a statement of conformity with a generally recognized and
generally available standard that contains the same information, e.g.,
those established by the American Chemical Society, U.S. Pharmacopeia,
National Formulary, and National Research Council. The labeling may also
include information concerning chemical/molecular composition, nucleic
acid sequence, binding affinity, cross-reactivities, and interaction
with substances of known clinical significance;
(v) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR part 1500 and any other warnings
appropriate to the hazard presented by the product;
(vi) The date of manufacture and appropriate storage instructions
adequate to protect the stability of the product. When applicable, these
instructions shall include such information as conditions of
temperature,
[[Page 104]]
light, humidity, date of expiration, and other pertinent factors. The
basis for such instructions shall be determined by reliable, meaningful,
and specific test methods, such as those described in Sec. 211.166 of
this chapter;
(vii) A declaration of the net quantity of contents, expressed in
terms of weight or volume, numerical count, or any combination of these
or other terms that accurately reflect the contents of the package. The
use of metric designations is encouraged, wherever appropriate;
(viii) The name and place of business of manufacturer, packer, or
distributor;
(ix) A lot or control number, identified as such, from which it is
possible to determine the complete manufacturing history of the product;
(x) For class I exempt ASR's, the statement: ``Analyte Specific
Reagent. Analytical and performance characteristics are not
established''; and
(xi) For class II and III ASR's, the statement: ``Analyte Specific
Reagent. Except as a component of the approved/cleared test (Name of
approved/cleared test), analytical and performance characteristics of
this ASR are not established.''
(2) In the case of immediate containers too small or otherwise
unable to accommodate a label with sufficient space to bear all such
information, and which are packaged within an outer container from which
they are removed for use, the information required by paragraphs (e)(1)
through (e)(6) of this section may appear in the outer container
labeling only.
(f) The labeling for over-the-counter (OTC) test sample collection
systems for drugs of abuse testing shall bear the following information
in language appropriate for the intended users:
(1) Adequate instructions for specimen collection and handling, and
for preparation and mailing of the specimen to the laboratory for
testing.
(2) An identification system to ensure that specimens are not mixed
up or otherwise misidentified at the laboratory, and that user anonymity
is maintained.
(3) The intended use or uses of the product, including what drugs
are to be identified in the specimen, a quantitative description of the
performance characteristics for those drugs (e.g., sensitivity and
specificity) in terms understandable to lay users, and the detection
period.
(4) A statement that confirmatory testing will be conducted on all
samples that initially test positive.
(5) A statement of warnings or precautions for users as established
in the regulations contained in 16 CFR part 1500 and any other warnings
appropriate to the hazard presented by the product.
(6) Adequate instructions on how to obtain test results from a
person who can explain their meaning, including the probability of false
positive and false negative results, as well as how to contact a trained
health professional if additional information on interpretation of test
results from the laboratory or followup counseling is desired.
(7) Name and place of business of the manufacturer, packer, or
distributor.
(g)(1) The applicant may provide the labeling information referenced
in this section in the form of:
(i) A symbol accompanied by explanatory text adjacent to the symbol;
(ii) A symbol not accompanied by adjacent explanatory text that:
(A) Is contained in a standard that FDA recognizes under its
authority in section 514(c) of the act;
(B) Is used according to the specifications for use of the symbol
set forth in FDA's section 514(c) recognition; and
(C) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used;
(iii) A symbol not accompanied by adjacent explanatory text that:
(A) Is established in a standard developed by a standards
development organization (SDO);
(B) Is not contained in a standard that is recognized by FDA under
its authority in section 514(c) of the act or is
[[Page 105]]
contained in a standard that is recognized by FDA but is not used
according to the specifications for use of the symbol set forth in FDA's
section 514(c) recognition;
(C) Is determined by the manufacturer to be likely to be read and
understood by the ordinary individual under customary conditions of
purchase and use in compliance with section 502(c) of the act;
(D) Is used according to the specifications for use of the symbol
set forth in the SDO-developed standard; and
(E) Is explained in a paper or electronic symbols glossary that is
included in the labeling for the device and the labeling on or within
the package containing the device bears a prominent and conspicuous
statement identifying the location of the symbols glossary that is
written in English or, in the case of articles distributed solely in
Puerto Rico or in a Territory where the predominant language is one
other than English, the predominant language may be used; or
(iv) The symbol statement ``Rx only'' or ``[rx] only'' used as
provided under paragraphs (a)(4) and (b)(5)(ii) of this section.
(2) The use of symbols in device labeling which do not meet the
requirements of paragraph (g)(1) of this section renders a device
misbranded under section 502(c) of the act.
(3) For purposes of paragraph (g)(1) of this section:
(i) An SDO is an organization that is nationally or internationally
recognized and that follows a process for standard development that is
transparent, (i.e., open to public scrutiny), where the participation is
balanced, where an appeals process is included, where the standard is
not in conflict with any statute, regulation, or policy under which FDA
operates, and where the standard is national or international in scope.
(ii) The term ``symbols glossary'' means a compiled listing of:
(A) Each SDO-established symbol used in the labeling for the device;
(B) The title and designation number of the SDO-developed standard
containing the symbol;
(C) The title of the symbol and its reference number, if any, in the
standard; and
(D) The meaning or explanatory text for the symbol as provided in
the FDA recognition or, if FDA has not recognized the standard or
portion of the standard in which the symbol is located or the symbol is
not used according to the specifications for use of the symbol set forth
in FDA's section 514(c) recognition, the explanatory text as provided in
the standard.
[41 FR 6903, Feb. 13, 1976, as amended at 45 FR 3750, Jan. 18, 1980; 45
FR 7484, Feb. 1, 1980; 47 FR 41107, Sept. 17, 1982; 47 FR 51109, Nov.
12, 1982; 48 FR 34470, July 29, 1983; 62 FR 62259, Nov. 21, 1997; 65 FR
18234, Apr. 7, 2000; 81 FR 38391, June 15, 2016]
Sec. 809.11 Exceptions or alternatives to labeling requirements
for in vitro diagnostic products for human use held by
the Strategic National Stockpile.
(a) The appropriate FDA Center Director may grant an exception or
alternative to any provision listed in paragraph (f) of this section and
not explicitly required by statute, for specified lots, batches, or
other units of an in vitro diagnostic product for human use, if the
Center Director determines that compliance with such labeling
requirement could adversely affect the safety, effectiveness, or
availability of such products that are or will be included in the
Strategic National Stockpile.
(b)(1)(i) A Strategic National Stockpile official or any entity that
manufactures (including labeling, packing, relabeling, or repackaging),
distributes, or stores an in vitro diagnostic product for human use that
is or will be included in the Strategic National Stockpile may submit,
with written concurrence from a Strategic National Stockpile official, a
written request for an exception or alternative described in paragraph
(a) of this section to the Center Director.
(ii) The Center Director may grant an exception or alternative
described in paragraph (a) of this section on his or her own initiative.
(2) A written request for an exception or alternative described in
paragraph (a) of this section must:
[[Page 106]]
(i) Identify the specified lots, batches, or other units of an in
vitro diagnostic product for human use that would be subject to the
exception or alternative;
(ii) Identify the labeling provision(s) listed in paragraph (f) of
this section that are the subject of the exception or alternative
request;
(iii) Explain why compliance with such labeling provision(s) could
adversely affect the safety, effectiveness, or availability of the
specified lots, batches, or other units of the in vitro diagnostic
product for human use that are or will be held in the Strategic National
Stockpile;
(iv) Describe any proposed safeguards or conditions that will be
implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product,
given the anticipated circumstances of use of the product;
(v) Provide a draft of the proposed labeling of the specified lots,
batches, or other units of the in vitro diagnostic products for human
use subject to the exception or alternative; and
(vi) Provide any other information requested by the Center Director
in support of the request.
(c) The Center Director must respond in writing to all requests
under this section. The Center Director may impose appropriate
conditions or safeguards when granting such an exception or alternative
under this section.
(d) A grant of an exception or alternative under this section will
include any safeguards or conditions deemed appropriate by the Center
Director to ensure that the labeling of the product subject to the
exception or alternative includes the information necessary for the safe
and effective use of the product, given the anticipated circumstances of
use.
(e) If the Center Director grants a request for an exception or
alternative to the labeling requirements under this section:
(1) The Center Director may determine that the submission and grant
of a written request under this section satisfies the provisions
relating to premarket notification submissions under Sec. 807.81(a)(3)
of this chapter.
(2)(i) For a Premarket Approval Application (PMA)-approved in vitro
diagnostic product for human use, the submission and grant of a written
request under this section satisfies the provisions relating to
submission of PMA supplements under Sec. 814.39 of this chapter;
however,
(ii) The grant of the request must be identified in a periodic
report under Sec. 814.84 of this chapter.
(f) The Center Director may grant an exception or alternative under
this section to the following provisions of this part, to the extent
that the requirements in these provisions are not explicitly required by
statute:
(1) Sec. 809.10(a)(1) through (a)(6) and (a)(9);
(2) Sec. 809.10(b);
(3) Sec. 809.10(c)(2);
(4) Sec. 809.10(d)(1)(i) through (d)(1)(v), (d)(1)(viii), and
(d)(2); and
(5) Sec. 809.10(e)(1)(i) through (e)(1)(vi) and (e)(1)(ix) through
(e)(1)(xi).
[72 FR 73601, Dec. 28, 2007]
Subpart C_Requirements for Manufacturers and Producers
Sec. 809.20 General requirements for manufacturers and producers of
in vitro diagnostic products.
(a) [Reserved]
(b) Compliance with good manufacturing practices. In vitro
diagnostic products shall be manufactured in accordance with the good
manufacturing practices requirements found in part 820 of this chapter
and, if applicable, with Sec. 610.44 of this chapter.
[41 FR 6903, Feb. 13, 1976, as amended at 42 FR 42530, Aug. 23, 1977; 43
FR 31527, July 21, 1978; 66 FR 31165, June 11, 2001]
Sec. 809.30 Restrictions on the sale, distribution and use
of analyte specific reagents.
(a) Analyte specific reagents (ASR's) (Sec. 864.4020 of this
chapter) are restricted devices under section 520(e) of the Federal
Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set
forth in this section.
(b) ASR's may only be sold to:
(1) In vitro diagnostic manufacturers;
(2) Clinical laboratories regulated under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), as
[[Page 107]]
qualified to perform high complexity testing under 42 CFR part 493 or
clinical laboratories regulated under VHA Directive 1106 (available from
Department of Veterans Affairs, Veterans Health Administration,
Washington, DC 20420); and
(3) Organizations that use the reagents to make tests for purposes
other than providing diagnostic information to patients and
practitioners, e.g., forensic, academic, research, and other nonclinical
laboratories.
(c) ASR's must be labeled in accordance with Sec. 809.10(e).
(d) Advertising and promotional materials for ASR's:
(1) Shall include the identity and purity (including source and
method of acquisition) of the analyte specific reagent and the identity
of the analyte;
(2) Shall include the statement for class I exempt ASR's: ``Analyte
Specific Reagent. Analytical and performance characteristics are not
established'';
(3) Shall include the statement for class II or III ASR's: ``Analyte
Specific Reagent. Except as a component of the approved/cleared test
(name of approved/cleared test), analytical and performance
characteristics are not established''; and
(4) Shall not make any statement regarding analytical or clinical
performance.
(e) The laboratory that develops an in-house test using the ASR
shall inform the ordering person of the test result by appending to the
test report the statement: ``This test was developed and its performance
characteristics determined by (Laboratory Name). It has not been cleared
or approved by the U.S. Food and Drug Administration.'' This statement
would not be applicable or required when test results are generated
using the test that was cleared or approved in conjunction with review
of the class II or III ASR.
(f) Ordering in-house tests that are developed using analyte
specific reagents is limited under section 520(e) of the act to
physicians and other persons authorized by applicable State law to order
such tests.
(g) The restrictions in paragraphs (c) through (f) of this section
do not apply when reagents that otherwise meet the analyte specific
reagent definition are sold to:
(1) In vitro diagnostic manufacturers; or
(2) Organizations that use the reagents to make tests for purposes
other than providing diagnostic information to patients and
practitioners, e.g., forensic, academic, research, and other nonclinical
laboratories.
[62 FR 62259, Nov. 21, 1997]
Sec. 809.40 Restrictions on the sale, distribution, and use of OTC
test sample collection systems for drugs of abuse testing.
(a) Over-the-counter (OTC) test sample collection systems for drugs
of abuse testing (Sec. 864.3260 of this chapter) are restricted devices
under section 520(e) of the Act subject to the restrictions set forth in
this section.
(b) Sample testing shall be performed in a laboratory using
screening tests that have been approved, cleared, or otherwise
recognized by the Food and Drug Administration as accurate and reliable
for the testing of such specimens for identifying drugs of abuse or
their metabolites.
(c) The laboratory performing the test(s) shall have, and shall be
recognized as having, adequate capability to reliably perform the
necessary screening and confirmatory tests, including adequate
capability to perform integrity checks of the biological specimens for
possible adulteration.
(d) All OTC test sample collection systems for drugs of abuse
testing shall be labeled in accordance with Sec. 809.10(f) and shall
provide an adequate system to communicate the proper interpretation of
test results from the laboratory to the lay purchaser.
[65 FR 18234, Apr. 7, 2000]
PART 810_MEDICAL DEVICE RECALL AUTHORITY--Table of Contents
Subpart A_General Provisions
Sec.
810.1 Scope.
810.2 Definitions.
810.3 Computation of time.
810.4 Service of orders.
[[Page 108]]
Subpart B_Mandatory Medical Device Recall Procedures
810.10 Cease distribution and notification order.
810.11 Regulatory hearing.
810.12 Written request for review of cease distribution and notification
order.
810.13 Mandatory recall order.
810.14 Cease distribution and notification or mandatory recall strategy.
810.15 Communications concerning a cease distribution and notification
or mandatory recall order.
810.16 Cease distribution and notification or mandatory recall order
status reports.
810.17 Termination of a cease distribution and notification or mandatory
recall order.
810.18 Public notice.
Authority: 21 U.S.C. 321, 331, 332, 333, 334, 351, 352, 355, 360h,
360i, 371, 374, 375.
Source: 61 FR 59018, Nov. 20, 1996, unless otherwise noted.
Subpart A_General Provisions
Sec. 810.1 Scope.
Part 810 describes the procedures that the Food and Drug
Administration will follow in exercising its medical device recall
authority under section 518(e) of the Federal Food, Drug, and Cosmetic
Act.
Sec. 810.2 Definitions.
As used in this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) Agency or FDA means the Food and Drug Administration.
(c) Cease distribution and notification strategy or mandatory recall
strategy means a planned, specific course of action to be taken by the
person named in a cease distribution and notification order or in a
mandatory recall order, which addresses the extent of the notification
or recall, the need for public warnings, and the extent of effectiveness
checks to be conducted.
(d) Consignee means any person or firm that has received, purchased,
or used a device that is subject to a cease distribution and
notification order or a mandatory recall order. Consignee does not mean
lay individuals or patients, i.e., nonhealth professionals.
(e) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a device,
without its physical removal from its point of use to some other
location.
(f) Device user facility means a hospital, ambulatory surgical
facility, nursing home, or outpatient treatment or diagnostic facility
that is not a physician's office.
(g) Health professionals means practitioners, including physicians,
nurses, pharmacists, dentists, respiratory therapists, physical
therapists, technologists, or any other practitioners or allied health
professionals that have a role in using a device for human use.
(h) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of
this chapter that does not meet the criteria in Sec. 1271.10(a) and
that is also regulated as a device.
(i) Reasonable probability means that it is more likely than not
that an event will occur.
(j) Serious, adverse health consequence means any significant
adverse experience, including those that may be either life-threatening
or involve permanent or long-term injuries, but excluding injuries that
are nonlife-threatening and that are temporary and reasonably
reversible.
(k) Recall means the correction or removal of a device for human use
where FDA finds that there is a reasonable probability that the device
would cause serious, adverse health consequences or death.
(l) Removal means the physical removal of a device from its point of
use to some other location for repair, modification, adjustment,
relabeling, destruction, or inspection.
(m) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec. 830.20 of this chapter. A unique
device identifier is composed of:
(1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
(2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
[[Page 109]]
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.
(v) For an HCT/P regulated as a device, the distinct identification
code required by Sec. 1271.290(c) of this chapter.
[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]
Sec. 810.3 Computation of time.
In computing any period of time prescribed or allowed by this part,
the day of the act or event from which the designated period of time
begins to run shall not be included. The computation of time is based
only on working days.
Sec. 810.4 Service of orders.
Orders issued under this part will be served in person by a
designated employee of FDA, or by certified or registered mail or
similar mail delivery service with a return receipt record reflecting
receipt, to the named person or designated agent at the named person's
or designated agent's last known address in FDA's records.
Subpart B_Mandatory Medical Device Recall Procedures
Sec. 810.10 Cease distribution and notification order.
(a) If, after providing the appropriate person with an opportunity
to consult with the agency, FDA finds that there is a reasonable
probability that a device intended for human use would cause serious,
adverse health consequences or death, the agency may issue a cease
distribution and notification order requiring the person named in the
order to immediately:
(1) Cease distribution of the device;
(2) Notify health professionals and device user facilities of the
order; and
(3) Instruct these professionals and device user facilities to cease
use of the device.
(b) FDA will include the following information in the order:
(1) The requirements of the order relating to cessation of
distribution and notification of health professionals and device user
facilities;
(2) Pertinent descriptive information to enable accurate and
immediate identification of the device subject to the order, including,
where known:
(i) The brand name of the device;
(ii) The common name, classification name, or usual name of the
device;
(iii) The model, catalog, or product code numbers of the device;
(iv) The manufacturing lot numbers or serial numbers of the device
or other identification numbers; and
(v) The unique device identifier (UDI) that appears on the device
label or on the device package; and
(3) A statement of the grounds for FDA's finding that there is a
reasonable probability that the device would cause serious, adverse
health consequences or death.
(c) FDA may also include in the order a model letter for notifying
health professionals and device user facilities of the order and a
requirement that notification of health professionals and device user
facilities be completed within a specified timeframe. The model letter
will include the key elements of information that the agency in its
discretion has determined, based on the circumstances surrounding the
issuance of each order, are necessary to inform health professionals and
device user facilities about the order.
(d) FDA may also require that the person named in the cease
distribution and notification order submit any or all of the following
information to the agency by a time specified in the order:
(1) The total number of units of the device produced and the
timespan of the production;
(2) The total number of units of the device estimated to be in
distribution channels;
(3) The total number of units of the device estimated to be
distributed to health professionals and device user facilities;
(4) The total number of units of the device estimated to be in the
hands of home users;
(5) Distribution information, including the names and addresses of
all consignees;
(6) A copy of any written communication used by the person named in
the
[[Page 110]]
order to notify health professionals and device user facilities;
(7) A proposed strategy for complying with the cease distribution
and notification order;
(8) Progress reports to be made at specified intervals, showing the
names and addresses of health professionals and device user facilities
that have been notified, names of specific individuals contacted within
device user facilities, and the dates of such contacts; and
(9) The name, address, and telephone number of the person who should
be contacted concerning implementation of the order.
(e) FDA will provide the person named in a cease distribution and
notification order with an opportunity for a regulatory hearing on the
actions required by the cease distribution and notification order and on
whether the order should be modified, or vacated, or amended to require
a mandatory recall of the device.
(f) FDA will also provide the person named in the cease distribution
and notification order with an opportunity, in lieu of a regulatory
hearing, to submit a written request to FDA asking that the order be
modified, or vacated, or amended.
(g) FDA will include in the cease distribution and notification
order the name, address, and telephone number of an agency employee to
whom any request for a regulatory hearing or agency review is to be
addressed.
[61 FR 59018, Nov. 20, 1996, as amended at 78 FR 58821, Sept. 24, 2013]
Sec. 810.11 Regulatory hearing.
(a) Any request for a regulatory hearing shall be submitted in
writing to the agency employee identified in the order within the
timeframe specified by FDA. Under Sec. 16.22(b) of this chapter, this
timeframe ordinarily will not be fewer than 3 working days after receipt
of the cease distribution and notification order. However, as provided
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or
presiding officer may waive, suspend, or modify any provision of part 16
under Sec. 10.19 of this chapter, including those pertaining to the
timing of the hearing. As provided in Sec. 16.26(a), the Commissioner
or presiding officer may deny a request for a hearing, in whole or in
part, if he or she determines that no genuine and substantial issue of
fact is raised by the material submitted in the request.
(b) If a request for a regulatory hearing is granted, the regulatory
hearing shall be limited to:
(1) Reviewing the actions required by the cease distribution and
notification order, determining if FDA should affirm, modify, or vacate
the order, and addressing an appropriate cease distribution and
notification strategy; and
(2) Determining whether FDA should amend the cease distribution and
notification order to require a recall of the device that was the
subject of the order. The hearing may also address the actions that
might be required by a recall order, including an appropriate recall
strategy, if FDA later orders a recall.
(c) If a request by the person named in a cease distribution and
notification order for a regulatory hearing is granted, the regulatory
hearing will be conducted in accordance with the procedures set out in
section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this
chapter, except that the order issued under Sec. 810.10, rather than a
notice under Sec. 16.22(a) of this chapter, provides the notice of
opportunity for a hearing and is part of the administrative record of
the regulatory hearing under Sec. 16.80(a) of this chapter. As provided
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or
presiding officer may waive, suspend, or modify any provision of part 16
under Sec. 10.19 of this chapter. As provided in Sec. 16.26(b), after
the hearing commences, the presiding officer may issue a summary
decision on any issue if the presiding officer determines that there is
no genuine and substantial issue of fact respecting that issue.
(d) If the person named in the cease distribution and notification
order does not request a regulatory hearing within the timeframe
specified by FDA in the cease distribution and notification order, that
person will be deemed to have waived his or her right to request a
hearing.
[[Page 111]]
(e) The presiding officer will ordinarily hold any regulatory
hearing requested under paragraph (a) of this section no fewer than 2
working days after receipt of the request for a hearing, under Sec.
16.24(e) of this chapter, and no later than 10 working days after the
date of issuance of the cease distribution and notification order.
However, FDA and the person named in the order may agree to a later date
or the presiding officer may determine that the hearing should be held
in fewer than 2 days. Moreover, as provided for in Sec. 16.60(h) of
this chapter, the Commissioner of Food and Drugs or presiding officer
may waive, suspend, or modify any provision of part 16 under Sec. 10.19
of this chapter, including those pertaining to the timing of the
hearing. After the presiding officer prepares a written report of the
hearing and the agency issues a final decision based on the report, the
presiding officer shall provide the requestor written notification of
the final decision to affirm, modify, or vacate the order or to amend
the order to require a recall of the device within 15 working days of
conducting a regulatory hearing.
Sec. 810.12 Written request for review of cease distribution
and notification order.
(a) In lieu of requesting a regulatory hearing under Sec. 810.11,
the person named in a cease distribution and notification order may
submit a written request to FDA asking that the order be modified or
vacated. Such person shall address the written request to the agency
employee identified in the order and shall submit the request within the
timeframe specified in the order, unless FDA and the person named in the
order agree to a later date.
(b) A written request for review of a cease distribution and
notification order shall identify each ground upon which the requestor
relies in asking that the order be modified or vacated, as well as
addressing an appropriate cease distribution and notification strategy,
and shall address whether the order should be amended to require a
recall of the device that was the subject of the order and the actions
required by such a recall order, including an appropriate recall
strategy.
(c) The agency official who issued the cease distribution and
notification order shall provide the requestor written notification of
the agency's decision to affirm, modify, or vacate the order or amend
the order to require a recall of the device within 15 working days of
receipt of the written request. The agency official shall include in
this written notification:
(1) A statement of the grounds for the decision to affirm, modify,
vacate, or amend the order; and
(2) The requirements of any modified or amended order.
Sec. 810.13 Mandatory recall order.
(a) If the person named in a cease distribution and notification
order does not request a regulatory hearing or submit a request for
agency review of the order, or, if the Commissioner of Food and Drugs or
the presiding officer denies a request for a hearing, or, if after
conducting a regulatory hearing under Sec. 810.11 or completing agency
review of a cease distribution and notification order under Sec.
810.12, FDA determines that the order should be amended to require a
recall of the device with respect to which the order was issued, FDA
shall amend the order to require such a recall. FDA shall amend the
order to require such a recall within 15 working days of issuance of a
cease distribution and notification order if a regulatory hearing or
agency review of the order is not requested, or within 15 working days
of denying a request for a hearing, or within 15 working days of
completing a regulatory hearing under Sec. 810.11, or within 15 working
days of receipt of a written request for review of a cease distribution
and notification order under Sec. 810.12.
(b) In a mandatory recall order, FDA may:
(1) Specify that the recall is to extend to the wholesale, retail,
or user level;
(2) Specify a timetable in accordance with which the recall is to
begin and be completed;
(3) Require the person named in the order to submit to the agency a
proposed recall strategy, as described in Sec. 810.14, and periodic
reports describing
[[Page 112]]
the progress of the mandatory recall, as described in Sec. 810.16; and
(4) Provide the person named in the order with a model recall
notification letter that includes the key elements of information that
FDA has determined are necessary to inform health professionals and
device user facilities.
(c) FDA will not include in a mandatory recall order a requirement
for:
(1) Recall of a device from individuals; or
(2) Recall of a device from device user facilities, if FDA
determines that the risk of recalling the device from the facilities
presents a greater health risk than the health risk of not recalling the
device from use, unless the device can be replaced immediately with an
equivalent device.
(d) FDA will include in a mandatory recall order provisions for
notification to individuals subject to the risks associated with use of
the device. If a significant number of such individuals cannot be
identified, FDA may notify such individuals under section 705(b) of the
act.
Sec. 810.14 Cease distribution and notification or mandatory recall strategy.
(a) General. The person named in a cease distribution and
notification order issued under Sec. 810.10 shall comply with the
order, which FDA will fashion as appropriate for the individual
circumstances of the case. The person named in a cease distribution and
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or
a mandatory recall order issued under Sec. 810.13 shall develop a
strategy for complying with the order that is appropriate for the
individual circumstances and that takes into account the following
factors:
(1) The nature of the serious, adverse health consequences related
to the device;
(2) The ease of identifying the device;
(3) The extent to which the risk presented by the device is obvious
to a health professional or device user facility; and
(4) The extent to which the device is used by health professionals
and device user facilities.
(b) Submission and review. (1) The person named in the cease
distribution and notification order modified under Sec. 810.11(e) or
Sec. 810.12(c) or mandatory recall order shall submit a copy of the
proposed strategy to the agency within the timeframe specified in the
order.
(2) The agency will review the proposed strategy and make any
changes to the strategy that it deems necessary within 7 working days of
receipt of the proposed strategy. The person named in the order shall
act in accordance with a strategy determined by FDA to be appropriate.
(c) Elements of the strategy. A proposed strategy shall meet all of
the following requirements:
(1)(i) The person named in the order shall specify the level in the
chain of distribution to which the cease distribution and notification
order or mandatory recall order is to extend as follows:
(A) Consumer or user level, e.g., health professionals, consignee,
or device user facility level, including any intermediate wholesale or
retail level; or
(B) Retail level, to the level immediately preceding the consumer or
user level, and including any intermediate level; or
(C) Wholesale level.
(ii) The person named in the order shall not recall a device from
individuals; and
(iii) The person named in the order shall not recall a device from
device user facilities if FDA notifies the person not to do so because
of a risk determination under Sec. 810.13(c)(2).
(2) The person named in a recall order shall ensure that the
strategy provides for notice to individuals subject to the risks
associated with use of the recalled device. The notice may be provided
through the individuals' health professionals if FDA determines that
such consultation is appropriate and would be the most effective method
of notifying patients.
(3) Effectiveness checks by the person named in the order are
required to verify that all health professionals, device user
facilities, consignees, and individuals, as appropriate, have been
notified of the cease distribution and notification order or mandatory
recall order and of the need to take appropriate action. The person
named in the cease distribution and notification
[[Page 113]]
order or the mandatory recall order shall specify in the strategy the
method(s) to be used in addition to written communications as required
by Sec. 810.15, i.e., personal visits, telephone calls, or a
combination thereof to contact all health professionals, device user
facilities, consignees, and individuals, as appropriate. The agency may
conduct additional audit checks where appropriate.
Sec. 810.15 Communications concerning a cease distribution and notification
or mandatory recall order.
(a) General. The person named in a cease distribution and
notification order issued under Sec. 810.10 or a mandatory recall order
issued under Sec. 810.13 is responsible for promptly notifying each
health professional, device user facility, consignee, or individual, as
appropriate, of the order. In accordance with Sec. 810.10(c) or Sec.
810.13(b)(4), FDA may provide the person named in the cease distribution
and notification or mandatory recall order with a model letter for
notifying each health professional, device user facility, consignee, or
individual, as appropriate, of the order. However, if FDA does not
provide the person named in the cease distribution and notification or
mandatory recall order with a model letter, the person named in a cease
distribution and notification order issued under Sec. 810.10, or a
mandatory recall order issued under Sec. 810.13, is responsible for
providing such notification. The purpose of the communication is to
convey:
(1) That FDA has found that there is a reasonable probability that
use of the device would cause a serious, adverse health consequence or
death;
(2) That the person named in the order has ceased distribution of
the device;
(3) That health professionals and device user facilities should
cease use of the device immediately;
(4) Where appropriate, that the device is subject to a mandatory
recall order; and
(5) Specific instructions on what should be done with the device.
(b) Implementation. The person named in a cease distribution and
notification order, or a mandatory recall order, shall notify the
appropriate person(s) of the order by verified written communication,
e.g., telegram, mailgram, or fax. The written communication and any
envelope in which it is sent or enclosed shall be conspicuously marked,
preferably in bold red ink: ``URGENT--[DEVICE CEASE DISTRIBUTION AND
NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].'' Telephone
calls or other personal contacts may be made in addition to, but not as
a substitute for, the verified written communication, and shall be
documented in an appropriate manner.
(c) Contents. The person named in the order shall ensure that the
notice of a cease distribution and notification order or mandatory
recall order:
(1) Is brief and to the point;
(2) Identifies clearly the device, size, lot number(s), code(s), or
serial number(s), and any other pertinent descriptive information to
facilitate accurate and immediate identification of the device;
(3) Explains concisely the serious, adverse health consequences that
may occur if use of the device were continued;
(4) Provides specific instructions on what should be done with the
device;
(5) Provides a ready means for the recipient of the communication to
confirm receipt of the communication and to notify the person named in
the order of the actions taken in response to the communication. Such
means may include, but are not limited to, the return of a postage-paid,
self-addressed post card or a toll-free call to the person named in the
order; and
(6) Does not contain irrelevant qualifications, promotional
materials, or any other statement that may detract from the message.
(d) Followup communications. The person named in the cease
distribution and notification order or mandatory recall order shall
ensure that followup communications are sent to all who fail to respond
to the initial communication.
(e) Responsibility of the recipient. Health professionals, device
user facilities, and consignees who receive a communication concerning a
cease distribution and notification order or a
[[Page 114]]
mandatory recall order should immediately follow the instructions set
forth in the communication. Where appropriate, these recipients should
immediately notify their consignees of the order in accordance with
paragraphs (b) and (c) of this section.
Sec. 810.16 Cease distribution and notification
or mandatory recall order status reports.
(a) The person named in a cease distribution and notification order
issued under Sec. 810.10 or a mandatory recall order issued under Sec.
810.13 shall submit periodic status reports to FDA to enable the agency
to assess the person's progress in complying with the order. The
frequency of such reports and the agency official to whom such reports
shall be submitted will be specified in the order.
(b) Unless otherwise specified in the order, each status report
shall contain the following information:
(1) The number and type of health professionals, device user
facilities, consignees, or individuals notified about the order and the
date and method of notification;
(2) The number and type of health professionals, device user
facilities, consignees, or individuals who have responded to the
communication and the quantity of the device on hand at these locations
at the time they received the communication;
(3) The number and type of health professionals, device user
facilities, consignees, or individuals who have not responded to the
communication;
(4) The number of devices returned or corrected by each health
professional, device user facility, consignee, or individual contacted,
and the quantity of products accounted for;
(5) The number and results of effectiveness checks that have been
made; and
(6) Estimated timeframes for completion of the requirements of the
cease distribution and notification order or mandatory recall order.
(c) The person named in the cease distribution and notification
order or recall order may discontinue the submission of status reports
when the agency terminates the order in accordance with Sec. 810.17.
Sec. 810.17 Termination of a cease distribution and notification
or mandatory recall order.
(a) The person named in a cease distribution and notification order
issued under Sec. 810.10 or a mandatory recall order issued under Sec.
810.13 may request termination of the order by submitting a written
request to FDA. The person submitting a request shall certify that he or
she has complied in full with all of the requirements of the order and
shall include a copy of the most current status report submitted to the
agency under Sec. 810.16. A request for termination of a recall order
shall include a description of the disposition of the recalled device.
(b) FDA may terminate a cease distribution and notification order
issued under Sec. 810.10 or a mandatory recall order issued under Sec.
810.13 when the agency determines that the person named in the order:
(1) Has taken all reasonable efforts to ensure and to verify that
all health professionals, device user facilities, consignees, and, where
appropriate, individuals have been notified of the cease distribution
and notification order, and to verify that they have been instructed to
cease use of the device and to take other appropriate action; or
(2) Has removed the device from the market or has corrected the
device so that use of the device would not cause serious, adverse health
consequences or death.
(c) FDA will provide written notification to the person named in the
order when a request for termination of a cease distribution and
notification order or a mandatory recall order has been granted or
denied. FDA will respond to a written request for termination of a cease
distribution and notification or recall order within 30 working days of
its receipt.
Sec. 810.18 Public notice.
The agency will make available to the public in the weekly FDA
Enforcement Report a descriptive listing of each new mandatory recall
issued under Sec. 810.13. The agency will delay public notification of
orders when the
[[Page 115]]
agency determines that such notification may cause unnecessary and
harmful anxiety in individuals and that initial consultation between
individuals and their health professionals is essential.
PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
Subpart A_General Provisions
Sec.
812.1 Scope.
812.2 Applicability.
812.3 Definitions.
812.5 Labeling of investigational devices.
812.7 Prohibition of promotion and other practices.
812.10 Waivers.
812.18 Import and export requirements.
812.19 Address for IDE correspondence.
Subpart B_Application and Administrative Action
812.20 Application.
812.25 Investigational plan.
812.27 Report of prior investigations.
812.28 xxx
812.30 FDA action on applications.
812.35 Supplemental applications.
812.36 Treatment use of an investigational device.
812.38 Confidentiality of data and information.
Subpart C_Responsibilities of Sponsors
812.40 General responsibilities of sponsors.
812.42 FDA and IRB approval.
812.43 Selecting investigators and monitors.
812.45 Informing investigators.
812.46 Monitoring investigations.
812.47 Emergency research under Sec. 50.24 of this chapter.
Subpart D_IRB Review and Approval
812.60 IRB composition, duties, and functions.
812.62 IRB approval.
812.64 IRB's continuing review.
812.65 [Reserved]
812.66 Significant risk device determinations.
Subpart E_Responsibilities of Investigators
812.100 General responsibilities of investigators.
812.110 Specific responsibilities of investigators.
812.119 Disqualification of a clinical investigator.
Subpart F [Reserved]
Subpart G_Records and Reports
812.140 Records.
812.145 Inspections.
812.150 Reports.
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-
360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42 U.S.C.
216, 241, 262, 263b-263n.
Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted.
Subpart A_General Provisions
Sec. 812.1 Scope.
(a) The purpose of this part is to encourage, to the extent
consistent with the protection of public health and safety and with
ethical standards, the discovery and development of useful devices
intended for human use, and to that end to maintain optimum freedom for
scientific investigators in their pursuit of this purpose. This part
provides procedures for the conduct of clinical investigations of
devices. An approved investigational device exemption (IDE) permits a
device that otherwise would be required to comply with a performance
standard or to have premarket approval to be shipped lawfully for the
purpose of conducting investigations of that device. An IDE approved
under Sec. 812.30 or considered approved under Sec. 812.2(b) exempts a
device from the requirements of the following sections of the Federal
Food, Drug, and Cosmetic Act (the act) and regulations issued
thereunder: Misbranding under section 502 of the act, registration,
listing, and premarket notification under section 510, performance
standards under section 514, premarket approval under section 515, a
banned device regulation under section 516, records and reports under
section 519, restricted device requirements under section 520(e), good
manufacturing practice requirements under section 520(f) except for the
requirements found in Sec. 820.30, if applicable (unless the sponsor
states an intention to comply with these requirements under Sec.
812.20(b)(3) or Sec. 812.140(b)(4)(v)) and color additive requirements
under section 721.
(b) References in this part to regulatory sections of the Code of
Federal
[[Page 116]]
Regulations are to chapter I of title 21, unless otherwise noted.
[45 FR 3751, Jan. 18, 1980, as amended at 59 FR 14366, Mar. 28, 1994; 61
FR 52654, Oct. 7, 1996]
Sec. 812.2 Applicability.
(a) General. This part applies to all clinical investigations of
devices to determine safety and effectiveness, except as provided in
paragraph (c) of this section.
(b) Abbreviated requirements. The following categories of
investigations are considered to have approved applications for IDE's,
unless FDA has notified a sponsor under Sec. 812.20(a) that approval of
an application is required:
(1) An investigation of a device other than a significant risk
device, if the device is not a banned device and the sponsor:
(i) Labels the device in accordance with Sec. 812.5;
(ii) Obtains IRB approval of the investigation after presenting the
reviewing IRB with a brief explanation of why the device is not a
significant risk device, and maintains such approval;
(iii) Ensures that each investigator participating in an
investigation of the device obtains from each subject under the
investigator's care, informed consent under part 50 and documents it,
unless documentation is waived by an IRB under Sec. 56.109(c).
(iv) Complies with the requirements of Sec. 812.46 with respect to
monitoring investigations;
(v) Maintains the records required under Sec. 812.140(b) (4) and
(5) and makes the reports required under Sec. 812.150(b) (1) through
(3) and (5) through (10);
(vi) Ensures that participating investigators maintain the records
required by Sec. 812.140(a)(3)(i) and make the reports required under
Sec. 812.150(a) (1), (2), (5), and (7); and
(vii) Complies with the prohibitions in Sec. 812.7 against
promotion and other practices.
(2) An investigation of a device other than one subject to paragraph
(e) of this section, if the investigation was begun on or before July
16, 1980, and to be completed, and is completed, on or before January
19, 1981.
(c) Exempted investigations. This part, with the exception of Sec.
812.119, does not apply to investigations of the following categories of
devices:
(1) A device, other than a transitional device, in commercial
distribution immediately before May 28, 1976, when used or investigated
in accordance with the indications in labeling in effect at that time.
(2) A device, other than a transitional device, introduced into
commercial distribution on or after May 28, 1976, that FDA has
determined to be substantially equivalent to a device in commercial
distribution immediately before May 28, 1976, and that is used or
investigated in accordance with the indications in the labeling FDA
reviewed under subpart E of part 807 in determining substantial
equivalence.
(3) A diagnostic device, if the sponsor complies with applicable
requirements in Sec. 809.10(c) and if the testing:
(i) Is noninvasive,
(ii) Does not require an invasive sampling procedure that presents
significant risk,
(iii) Does not by design or intention introduce energy into a
subject, and
(iv) Is not used as a diagnostic procedure without confirmation of
the diagnosis by another, medically established diagnostic product or
procedure.
(4) A device undergoing consumer preference testing, testing of a
modification, or testing of a combination of two or more devices in
commercial distribution, if the testing is not for the purpose of
determining safety or effectiveness and does not put subjects at risk.
(5) A device intended solely for veterinary use.
(6) A device shipped solely for research on or with laboratory
animals and labeled in accordance with Sec. 812.5(c).
(7) A custom device as defined in Sec. 812.3(b), unless the device
is being used to determine safety or effectiveness for commercial
distribution.
(d) Limit on certain exemptions. In the case of class II or class
III device described in paragraph (c)(1) or (2) of this section, this
part applies beginning on
[[Page 117]]
the date stipulated in an FDA regulation or order that calls for the
submission of premarket approval applications for an unapproved class
III device, or establishes a performance standard for a class II device.
(e) Investigations subject to IND's. A sponsor that, on July 16,
1980, has an effective investigational new drug application (IND) for an
investigation of a device shall continue to comply with the requirements
of part 312 until 90 days after that date. To continue the investigation
after that date, a sponsor shall comply with paragraph (b)(1) of this
section, if the device is not a significant risk device, or shall have
obtained FDA approval under Sec. 812.30 of an IDE application for the
investigation of the device.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 46
FR 14340, Feb. 27, 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan. 29,
1997; 62 FR 12096, Mar. 14, 1997]
Sec. 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections
201-901, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).
(b) A custom device means a device within the meaning of section
520(b) of the Federal Food, Drug, and Cosmetic Act.
(c) FDA means the Food and Drug Administration.
(d) Implant means a device that is placed into a surgically or
naturally formed cavity of the human body if it is intended to remain
there for a period of 30 days or more. FDA may, in order to protect
public health, determine that devices placed in subjects for shorter
periods are also ``implants'' for purposes of this part.
(e) Institution means a person, other than an individual, who
engages in the conduct of research on subjects or in the delivery of
medical services to individuals as a primary activity or as an adjunct
to providing residential or custodial care to humans. The term includes,
for example, a hospital, retirement home, confinement facility, academic
establishment, and device manufacturer. The term has the same meaning as
``facility'' in section 520(g) of the act.
(f) Institutional review board (IRB) means any board, committee, or
other group formally designated by an institution to review biomedical
research involving subjects and established, operated, and functioning
in conformance with part 56. The term has the same meaning as
``institutional review committee'' in section 520(g) of the act.
(g) Investigational device means a device, including a transitional
device, that is the object of an investigation.
(h) Investigation means a clinical investigation or research
involving one or more subjects to determine the safety or effectiveness
of a device.
(i) Investigator means an individual who actually conducts a
clinical investigation, i.e., under whose immediate direction the test
article is administered or dispensed to, or used involving, a subject,
or, in the event of an investigation conducted by a team of individuals,
is the responsible leader of that team.
(j) Monitor, when used as a noun, means an individual designated by
a sponsor or contract research organization to oversee the progress of
an investigation. The monitor may be an employee of a sponsor or a
consultant to the sponsor, or an employee of or consultant to a contract
research organization. Monitor, when used as a verb, means to oversee an
investigation.
(k) Noninvasive, when applied to a diagnostic device or procedure,
means one that does not by design or intention: (1) Penetrate or pierce
the skin or mucous membranes of the body, the ocular cavity, or the
urethra, or (2) enter the ear beyond the external auditory canal, the
nose beyond the nares, the mouth beyond the pharynx, the anal canal
beyond the rectum, or the vagina beyond the cervical os. For purposes of
this part, blood sampling that involves simple venipuncture is
considered noninvasive, and the use of surplus samples of body fluids or
tissues that are left over from samples taken for noninvestigational
purposes is also considered noninvasive.
(l) Person includes any individual, partnership, corporation,
association, scientific or academic establishment, Government agency or
organizational unit of a Government agency, and any other legal entity.
[[Page 118]]
(m) Significant risk device means an investigational device that:
(1) Is intended as an implant and presents a potential for serious
risk to the health, safety, or welfare of a subject;
(2) Is purported or represented to be for a use in supporting or
sustaining human life and presents a potential for serious risk to the
health, safety, or welfare of a subject;
(3) Is for a use of substantial importance in diagnosing, curing,
mitigating, or treating disease, or otherwise preventing impairment of
human health and presents a potential for serious risk to the health,
safety, or welfare of a subject; or
(4) Otherwise presents a potential for serious risk to the health,
safety, or welfare of a subject.
(n) Sponsor means a person who initiates, but who does not actually
conduct, the investigation, that is, the investigational device is
administered, dispensed, or used under the immediate direction of
another individual. A person other than an individual that uses one or
more of its own employees to conduct an investigation that it has
initiated is a sponsor, not a sponsor-investigator, and the employees
are investigators.
(o) Sponsor-investigator means an individual who both initiates and
actually conducts, alone or with others, an investigation, that is,
under whose immediate direction the investigational device is
administered, dispensed, or used. The term does not include any person
other than an individual. The obligations of a sponsor-investigator
under this part include those of an investigator and those of a sponsor.
(p) Subject means a human who participates in an investigation,
either as an individual on whom or on whose specimen an investigational
device is used or as a control. A subject may be in normal health or may
have a medical condition or disease.
(q) Termination means a discontinuance, by sponsor or by withdrawal
of IRB or FDA approval, of an investigation before completion.
(r) Transitional device means a device subject to section 520(l) of
the act, that is, a device that FDA considered to be a new drug or an
antibiotic drug before May 28, 1976.
(s) Unanticipated adverse device effect means any serious adverse
effect on health or safety or any life-threatening problem or death
caused by, or associated with, a device, if that effect, problem, or
death was not previously identified in nature, severity, or degree of
incidence in the investigational plan or application (including a
supplementary plan or application), or any other unanticipated serious
problem associated with a device that relates to the rights, safety, or
welfare of subjects.
(t) Independent ethics committee (IEC) means an independent review
panel that is responsible for ensuring the protection of the rights,
safety, and well-being of subjects involved in a clinical investigation
and is adequately constituted to ensure that protection. An
institutional review board (IRB), as defined in paragraph (f) of this
section and subject to the requirements of part 56 of this chapter, is
one type of IEC.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 48
FR 15622, Apr. 12, 1983; 81 FR 70340, Oct. 12, 2016; 83 FR 7385, Feb.
21, 2018; 83 FR 7385, Feb. 21, 2018]
Sec. 812.5 Labeling of investigational devices.
(a) Contents. An investigational device or its immediate package
shall bear a label with the following information: the name and place of
business of the manufacturer, packer, or distributor (in accordance with
Sec. 801.1), the quantity of contents, if appropriate, and the
following statement: ``CAUTION--Investigational device. Limited by
Federal (or United States) law to investigational use.'' The label or
other labeling shall describe all relevant contraindications, hazards,
adverse effects, interfering substances or devices, warnings, and
precautions.
(b) Prohibitions. The labeling of an investigational device shall
not bear any statement that is false or misleading in any particular and
shall not represent that the device is safe or effective for the
purposes for which it is being investigated.
(c) Animal research. An investigational device shipped solely for
research on or with laboratory animals shall bear on its label the
following statement: ``CAUTION--Device for investigational use in
laboratory animals
[[Page 119]]
or other tests that do not involve human subjects.''
(d) The appropriate FDA Center Director, according to the procedures
set forth in Sec. 801.128 or Sec. 809.11 of this chapter, may grant an
exception or alternative to the provisions in paragraphs (a) and (c) of
this section, to the extent that these provisions are not explicitly
required by statute, for specified lots, batches, or other units of a
device that are or will be included in the Strategic National Stockpile.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980; 72
FR 73602, Dec. 28, 2007]
Sec. 812.7 Prohibition of promotion and other practices.
A sponsor, investigator, or any person acting for or on behalf of a
sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after
FDA has approved the device for commercial distribution.
(b) Commercialize an investigational device by charging the subjects
or investigators for a device a price larger than that necessary to
recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation. If data developed by the
investigation indicate in the case of a class III device that premarket
approval cannot be justified or in the case of a class II device that it
will not comply with an applicable performance standard or an amendment
to that standard, the sponsor shall promptly terminate the
investigation.
(d) Represent that an investigational device is safe or effective
for the purposes for which it is being investigated.
Sec. 812.10 Waivers.
(a) Request. A sponsor may request FDA to waive any requirement of
this part. A waiver request, with supporting documentation, may be
submitted separately or as part of an application to the address in
Sec. 812.19.
(b) FDA action. FDA may by letter grant a waiver of any requirement
that FDA finds is not required by the act and is unnecessary to protect
the rights, safety, or welfare of human subjects.
(c) Effect of request. Any requirement shall continue to apply
unless and until FDA waives it.
Sec. 812.18 Import and export requirements.
(a) Imports. In addition to complying with other requirements of
this part, a person who imports or offers for importation an
investigational device subject to this part shall be the agent of the
foreign exporter with respect to investigations of the device and shall
act as the sponsor of the clinical investigation, or ensure that another
person acts as the agent of the foreign exporter and the sponsor of the
investigation.
(b) Exports. A person exporting an investigational device subject to
this part shall obtain FDA's prior approval, as required by section
801(e) of the act or comply with section 802 of the act.
[45 FR 3751, Jan. 18, 1980, as amended at 62 FR 26229, May 13, 1997]
Sec. 812.19 Address for IDE correspondence.
(a) If you are sending an application, supplemental application,
report, request for waiver, request for import or export approval, or
other correspondence relating to matters covered by this part, you must
send the submission to the appropriate address as follows:
(1) For devices regulated by the Center for Devices and Radiological
Health, send it to the current address displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation and
Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
(3) For devices regulated by the Center for Drug Evaluation and
Research, send it to Central Document Control Room, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266.
(b) You must state on the outside wrapper of each submission what
the
[[Page 120]]
submission is, for example, an ``IDE application,'' a ``supplemental IDE
application,'' or a ``correspondence concerning an IDE (or an IDE
application).''
[71 FR 42048, July 25, 2006, as amended at 75 FR 20915, Apr. 22, 2010;
80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019]
Subpart B_Application and Administrative Action
Sec. 812.20 Application.
(a) Submission. (1) A sponsor shall submit an application to FDA if
the sponsor intends to use a significant risk device in an
investigation, intends to conduct an investigation that involves an
exception from informed consent under Sec. 50.24 of this chapter, or if
FDA notifies the sponsor that an application is required for an
investigation.
(2) A sponsor shall not begin an investigation for which FDA's
approval of an application is required until FDA has approved the
application.
(3) A sponsor shall submit a signed ``Application for an
Investigational Device Exemption'' (IDE application), together with
accompanying materials in electronic format, to one of the addresses in
Sec. 812.19, and if eCopy by registered mail or by hand. Subsequent
correspondence concerning an application or a supplemental application
shall be submitted in electronic format and if eCopy by registered mail
or by hand.
(4)(i) A sponsor shall submit a separate IDE for any clinical
investigation involving an exception from informed consent under Sec.
50.24 of this chapter. Such a clinical investigation is not permitted to
proceed without the prior written authorization of FDA. FDA shall
provide a written determination 30 days after FDA receives the IDE or
earlier.
(ii) If the investigation involves an exception from informed
consent under Sec. 50.24 of this chapter, the sponsor shall prominently
identify on the cover sheet that the investigation is subject to the
requirements in Sec. 50.24 of this chapter.
(b) Contents. An IDE application shall include, in the following
order:
(1) The name and address of the sponsor.
(2) A complete report of prior investigations of the device and an
accurate summary of those sections of the investigational plan described
in Sec. 812.25(a) through (e) or, in lieu of the summary, the complete
plan. The sponsor shall submit to FDA a complete investigational plan
and a complete report of prior investigations of the device if no IRB
has reviewed them, if FDA has found an IRB's review inadequate, or if
FDA requests them.
(3) A description of the methods, facilities, and controls used for
the manufacture, processing, packing, storage, and, where appropriate,
installation of the device, in sufficient detail so that a person
generally familiar with good manufacturing practices can make a
knowledgeable judgment about the quality control used in the manufacture
of the device.
(4) An example of the agreements to be entered into by all
investigators to comply with investigator obligations under this part,
and a list of the names and addresses of all investigators who have
signed the agreement.
(5) A certification that all investigators who will participate in
the investigation have signed the agreement, that the list of
investigators includes all the investigators participating in the
investigation, and that no investigators will be added to the
investigation until they have signed the agreement.
(6) A list of the name, address, and chairperson of each IRB that
has been or will be asked to review the investigation and a
certification of the action concerning the investigation taken by each
such IRB.
(7) The name and address of any institution at which a part of the
investigation may be conducted that has not been identified in
accordance with paragraph (b)(6) of this section.
(8) If the device is to be sold, the amount to be charged and an
explanation of why sale does not constitute commercialization of the
device.
(9) A claim for categorical exclusion under Sec. 25.30 or Sec.
25.34 or an environmental assessment under Sec. 25.40.
(10) Copies of all labeling for the device.
[[Page 121]]
(11) Copies of all forms and informational materials to be provided
to subjects to obtain informed consent.
(12) Any other relevant information FDA requests for review of the
application.
(c) Additional information. FDA may request additional information
concerning an investigation or revision in the investigational plan. The
sponsor may treat such a request as a disapproval of the application for
purposes of requesting a hearing under part 16.
(d) Information previously submitted. Information previously
submitted to the Center for Devices and Radiological Health, the Center
for Biologics Evaluation and Research, or the Center for Drug Evaluation
and Research, as applicable, in accordance with this chapter ordinarily
need not be resubmitted, but may be incorporated by reference.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50
FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2,
1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999; 73 FR
49942, Aug. 25, 2008; 84 FR 68339, Dec. 16, 2019]
Sec. 812.25 Investigational plan.
The investigational plan shall include, in the following order:
(a) Purpose. The name and intended use of the device and the
objectives and duration of the investigation.
(b) Protocol. A written protocol describing the methodology to be
used and an analysis of the protocol demonstrating that the
investigation is scientifically sound.
(c) Risk analysis. A description and analysis of all increased risks
to which subjects will be exposed by the investigation; the manner in
which these risks will be minimized; a justification for the
investigation; and a description of the patient population, including
the number, age, sex, and condition.
(d) Description of device. A description of each important
component, ingredient, property, and principle of operation of the
device and of each anticipated change in the device during the course of
the investigation.
(e) Monitoring procedures. The sponsor's written procedures for
monitoring the investigation and the name and address of any monitor.
(f) Labeling. Copies of all labeling for the device.
(g) Consent materials. Copies of all forms and informational
materials to be provided to subjects to obtain informed consent.
(h) IRB information. A list of the names, locations, and
chairpersons of all IRB's that have been or will be asked to review the
investigation, and a certification of any action taken by any of those
IRB's with respect to the investigation.
(i) Other institutions. The name and address of each institution at
which a part of the investigation may be conducted that has not been
identified in paragraph (h) of this section.
(j) Additional records and reports. A description of records and
reports that will be maintained on the investigation in addition to
those prescribed in subpart G.
Sec. 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include
reports of all prior clinical, animal, and laboratory testing of the
device and shall be comprehensive and adequate to justify the proposed
investigation.
(b) Specific contents. The report also shall include:
(1) A bibliography of all publications, whether adverse or
supportive, that are relevant to an evaluation of the safety or
effectiveness of the device, copies of all published and unpublished
adverse information, and, if requested by an IRB or FDA, copies of other
significant publications.
(2) A summary of all other unpublished information (whether adverse
or supportive) in the possession of, or reasonably obtainable by, the
sponsor that is relevant to an evaluation of the safety or effectiveness
of the device.
(3) If information on nonclinical laboratory studies is provided, a
statement that all such studies have been conducted in compliance with
applicable requirements in the good laboratory practice regulations in
part 58, or if any such study was not conducted in compliance with such
regulations, a brief statement of the reason for the noncompliance.
Failure or inability to
[[Page 122]]
comply with this requirement does not justify failure to provide
information on a relevant nonclinical test study.
(4)(i) If data from clinical investigations conducted in the United
States are provided, a statement that each investigation was conducted
in compliance with applicable requirements in the protection of human
subjects regulations in part 50 of this chapter, the institutional
review boards regulations in part 56 of this chapter, or was not subject
to the regulations under Sec. 56.104 or Sec. 56.105, and the
investigational device exemptions regulations in this part, or if any
such investigation was not conducted in compliance with those
regulations, a brief statement of the reason for the noncompliance.
Failure or inability to comply with these requirements does not justify
failure to provide information on a relevant clinical investigation.
(ii) If data from clinical investigations conducted outside the
United States are provided to support the IDE, the requirements under
Sec. 812.28 apply. If any such investigation was not conducted in
accordance with good clinical practice (GCP) as described in Sec.
812.28(a), the report of prior investigations shall include either a
waiver request in accordance with Sec. 812.28(c) or a brief statement
of the reason for not conducting the investigation in accordance with
GCP and a description of steps taken to ensure that the data and results
are credible and accurate and that the rights, safety, and well-being of
subjects have been adequately protected. Failure or inability to comply
with these requirements does not justify failure to provide information
on a relevant clinical investigation.
[45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985; 83
FR 7385, Feb. 21, 2018]
Sec. 812.28 Acceptance of data from clinical investigations
conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted
outside the United States to support an IDE or a device marketing
application or submission (an application under section 515 or 520(m) of
the Federal Food, Drug, and Cosmetic Act, a premarket notification
submission under section 510(k) of the Federal Food, Drug, and Cosmetic
Act, or a request for De Novo classification under section 513(f)(2) of
the Federal Food, Drug, and Cosmetic Act). FDA will accept information
on a clinical investigation conducted outside the United States to
support an IDE or a device marketing application or submission if the
investigation is well-designed and well-conducted and the following
conditions are met:
(1) A statement is provided that the investigation was conducted in
accordance with good clinical practice (GCP). For the purposes of this
section, GCP is defined as a standard for the design, conduct,
performance, monitoring, auditing, recording, analysis, and reporting of
clinical investigations in a way that provides assurance that the data
and results are credible and accurate and that the rights, safety, and
well-being of subjects are protected. GCP includes review and approval
(or provision of a favorable opinion) by an independent ethics committee
(IEC) before initiating an investigation, continuing review of an
ongoing investigation by an IEC, and obtaining and documenting the
freely given informed consent of the subject (or a subject's legally
authorized representative, if the subject is unable to provide informed
consent) before initiating an investigation. GCP does not require
informed consent in life-threatening situations when the IEC reviewing
the investigation finds, before initiation of the investigation, that
informed consent is not feasible and either that the conditions present
are consistent with those described in Sec. 50.23 or Sec. 50.24(a) of
this chapter, or that the measures described in the protocol or
elsewhere will protect the rights, safety, and well-being of subjects.
(2) In addition to the information required elsewhere in parts 807,
812, and 814 of this chapter, as applicable, the information in
paragraph (b) of this section is submitted, as follows:
(i) For an investigation of a significant risk device, as defined in
Sec. 812.3(m), the supporting information as described in paragraph (b)
of this section is submitted.
(ii) For an investigation of a device, other than a significant risk
device,
[[Page 123]]
the supporting information as described in paragraphs (b)(1), (4), (5),
(7) through (9), and (11) of this section is submitted, and the
supporting information as described in paragraph (b)(10) of this section
and the rationale for determining the investigation is of a device other
than a significant risk device are made available for agency review upon
request by FDA.
(iii) For a device investigation that meets the exemption criteria
in Sec. 812.2(c), the supporting information as described in paragraphs
(b)(1), (4), (5), (7) through (11) of this section and the rationale for
determining the investigation meets the exemption criteria in Sec.
812.2(c) are made available for agency review upon request by FDA.
(3) FDA is able to validate the data from the investigation through
an onsite inspection, or through other appropriate means, if the agency
deems it necessary.
(b) Supporting information. A sponsor or applicant who submits data
from a clinical investigation conducted outside the United States to
support an IDE or a device marketing application or submission, in
addition to information required elsewhere in parts 807, 812, and 814 of
this chapter, as applicable, shall provide a description of the actions
the sponsor or applicant took to ensure that the research conformed to
GCP as described in paragraph (a)(1) of this section. The description is
not required to duplicate information already submitted in the
application or submission. Instead, the description must provide either
the following information, as specified in paragraph (a)(2) of this
section, or a cross-reference to another section of the application or
submission where the information is located:
(1) The names of the investigators and the names and addresses of
the research facilities and sites where records relating to the
investigation are maintained;
(2) The investigator's qualifications;
(3) A description of the research facility(ies);
(4) A detailed summary of the protocol and results of the
investigation and, should FDA request, case records maintained by the
investigator or additional background data such as hospital or other
institutional records;
(5) Either a statement that the device used in the investigation
conducted outside the United States is identical to the device that is
the subject of the submission or application, or a detailed description
of the device and each important component (including all materials and
specifications), ingredient, property, and principle of operation of the
device used in the investigation conducted outside the United States and
a comparison to the device that is the subject of the submission or
application that indicates how the device used in the investigation is
similar to and/or different from the device that is the subject of the
submission or application;
(6) If the investigation is intended to support the safety and
effectiveness of a device, a discussion demonstrating that the data and
information constitute valid scientific evidence within the meaning of
Sec. 860.7 of this chapter;
(7) The name and address of the IEC that reviewed the investigation
and a statement that the IEC meets the definition in Sec. 812.3(t). The
sponsor or applicant must maintain records supporting such statement,
including records describing the qualifications of IEC members, and make
these records available for agency review upon request;
(8) A summary of the IEC's decision to approve or modify and approve
the investigation, or to provide a favorable opinion;
(9) A description of how informed consent was obtained;
(10) A description of what incentives, if any, were provided to
subjects to participate in the investigation;
(11) A description of how the sponsor(s) monitored the investigation
and ensured that the investigation was carried out consistently with the
protocol; and
(12) A description of how investigators were trained to comply with
GCP (as described in paragraph (a)(1) of this section) and to conduct
the investigation in accordance with the protocol, and a statement on
whether written
[[Page 124]]
commitments by investigators to comply with GCP and the protocol were
obtained. Any signed written commitments by investigators must be
maintained by the sponsor or applicant and made available for agency
review upon request.
(c) Waivers. (1) A sponsor or applicant may ask FDA to waive any
applicable requirements under paragraphs (a)(1) and (b) of this section.
A waiver request may be submitted in an IDE or in an amendment or
supplement to an IDE, in a device marketing application or submission
(an application under section 515 or 520(m) of the Federal Food, Drug,
and Cosmetic Act, a premarket notification submission under section
510(k) of the Federal Food, Drug, and Cosmetic Act, or a request for De
Novo classification under section 513(f)(2) of the Federal Food, Drug,
and Cosmetic Act) or in an amendment or supplement to a device marketing
application or submission, or in a pre-submission. A waiver request is
required to contain at least one of the following:
(i) An explanation why the sponsor's or applicant's compliance with
the requirement is unnecessary or cannot be achieved;
(ii) A description of an alternative submission or course of action
that satisfies the purpose of the requirement; or
(iii) Other information justifying a waiver.
(2) FDA may grant a waiver if it finds that doing so would be in the
interest of the public health.
(d) Records. A sponsor or applicant must retain the records required
by this section for a clinical investigation conducted outside the
United States as follows:
(1) If the investigation is submitted in support of an IDE, for 2
years after the termination or completion of the IDE; and
(2) If the investigation is submitted in support of a premarket
approval application, a notice of completion of a product development
protocol, a humanitarian device exemption application, a premarket
notification submission, or a request for De Novo classification, for 2
years after an agency decision on that submission or application.
(e) Clinical investigations conducted outside of the United States
that do not meet conditions. For clinical investigations conducted
outside the United States that do not meet the conditions under
paragraph (a) of this section, FDA may accept the information from such
clinical investigations to support an IDE or a device marketing
application or submission if FDA believes that the data and results from
such clinical investigation are credible and accurate and that the
rights, safety, and well-being of subjects have been adequately
protected.
[83 FR 7386, Feb. 21, 2018]
Sec. 812.30 FDA action on applications.
(a) Approval or disapproval. FDA will notify the sponsor in writing
of the date it receives an application. FDA may approve an investigation
as proposed, approve it with modifications, or disapprove it. An
investigation may not begin until:
(1) Thirty days after FDA receives the application at the address in
Sec. 812.19 for the investigation of a device other than a banned
device, unless FDA notifies the sponsor that the investigation may not
begin; or
(2) FDA approves, by order, an IDE for the investigation.
(b) Grounds for disapproval or withdrawal. FDA may disapprove or
withdraw approval of an application if FDA finds that:
(1) There has been a failure to comply with any requirement of this
part or the act, any other applicable regulation or statute, or any
condition of approval imposed by an IRB or FDA.
(2) The application or a report contains an untrue statement of a
material fact, or omits material information required by this part.
(3) The sponsor fails to respond to a request for additional
information within the time prescribed by FDA.
(4) There is reason to believe that the risks to the subjects are
not outweighed by the anticipated benefits to the subjects and the
importance of the knowledge to be gained, or informed consent is
inadequate, or the investigation is scientifically unsound, or there
[[Page 125]]
is reason to believe that the device as used is ineffective.
(5) It is otherwise unreasonable to begin or to continue the
investigation owing to the way in which the device is used or the
inadequacy of:
(i) The report of prior investigations or the investigational plan;
(ii) The methods, facilities, and controls used for the
manufacturing, processing, packaging, storage, and, where appropriate,
installation of the device; or
(iii) Monitoring and review of the investigation.
(c) Notice of disapproval or withdrawal. If FDA disapproves an
application or proposes to withdraw approval of an application, FDA will
notify the sponsor in writing.
(1) A disapproval order will contain a complete statement of the
reasons for disapproval and a statement that the sponsor has an
opportunity to request a hearing under part 16.
(2) A notice of a proposed withdrawal of approval will contain a
complete statement of the reasons for withdrawal and a statement that
the sponsor has an opportunity to request a hearing under part 16. FDA
will provide the opportunity for hearing before withdrawal of approval,
unless FDA determines in the notice that continuation of testing under
the exemption will result in an unreasonble risk to the public health
and orders withdrawal of approval before any hearing.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58842, Sept. 5, 1980]
Sec. 812.35 Supplemental applications.
(a) Changes in investigational plan--(1) Changes requiring prior
approval. Except as described in paragraphs (a)(2) through (a)(4) of
this section, a sponsor must obtain approval of a supplemental
application under Sec. 812.30(a), and IRB approval when appropriate
(see Sec. Sec. 56.110 and 56.111 of this chapter), prior to
implementing a change to an investigational plan. If a sponsor intends
to conduct an investigation that involves an exception to informed
consent under Sec. 50.24 of this chapter, the sponsor shall submit a
separate investigational device exemption (IDE) application in
accordance with Sec. 812.20(a).
(2) Changes effected for emergency use. The requirements of
paragraph (a)(1) of this section regarding FDA approval of a supplement
do not apply in the case of a deviation from the investigational plan to
protect the life or physical well-being of a subject in an emergency.
Such deviation shall be reported to FDA within 5-working days after the
sponsor learns of it (see Sec. 812.150(a)(4)).
(3) Changes effected with notice to FDA within 5 days. A sponsor may
make certain changes without prior approval of a supplemental
application under paragraph (a)(1) of this section if the sponsor
determines that these changes meet the criteria described in paragraphs
(a)(3)(i) and (a)(3)(ii) of this section, on the basis of credible
information defined in paragraph (a)(3)(iii) of this section, and the
sponsor provides notice to FDA within 5-working days of making these
changes.
(i) Developmental changes. The requirements in paragraph (a)(1) of
this section regarding FDA approval of a supplement do not apply to
developmental changes in the device (including manufacturing changes)
that do not constitute a significant change in design or basic
principles of operation and that are made in response to information
gathered during the course of an investigation.
(ii) Changes to clinical protocol. The requirements in paragraph
(a)(1) of this section regarding FDA approval of a supplement do not
apply to changes to clinical protocols that do not affect:
(A) The validity of the data or information resulting from the
completion of the approved protocol, or the relationship of likely
patient risk to benefit relied upon to approve the protocol;
(B) The scientific soundness of the investigational plan; or
(C) The rights, safety, or welfare of the human subjects involved in
the investigation.
(iii) Definition of credible information. (A) Credible information
to support developmental changes in the device (including manufacturing
changes) includes data generated under the design control procedures of
Sec. 820.30, preclinical/animal testing, peer reviewed published
literature, or other reliable
[[Page 126]]
information such as clinical information gathered during a trial or
marketing.
(B) Credible information to support changes to clinical protocols is
defined as the sponsor's documentation supporting the conclusion that a
change does not have a significant impact on the study design or planned
statistical analysis, and that the change does not affect the rights,
safety, or welfare of the subjects. Documentation shall include
information such as peer reviewed published literature, the
recommendation of the clinical investigator(s), and/or the data gathered
during the clinical trial or marketing.
(iv) Notice of IDE change. Changes meeting the criteria in
paragraphs (a)(3)(i) and (a)(3)(ii) of this section that are supported
by credible information as defined in paragraph (a)(3)(iii) of this
section may be made without prior FDA approval if the sponsor submits a
notice of the change to the IDE not later than 5-working days after
making the change. Changes to devices are deemed to occur on the date
the device, manufactured incorporating the design or manufacturing
change, is distributed to the investigator(s). Changes to a clinical
protocol are deemed to occur when a clinical investigator is notified by
the sponsor that the change should be implemented in the protocol or,
for sponsor-investigator studies, when a sponsor-investigator
incorporates the change in the protocol. Such notices shall be
identified as a ``notice of IDE change.''
(A) For a developmental or manufacturing change to the device, the
notice shall include a summary of the relevant information gathered
during the course of the investigation upon which the change was based;
a description of the change to the device or manufacturing process
(cross-referenced to the appropriate sections of the original device
description or manufacturing process); and, if design controls were used
to assess the change, a statement that no new risks were identified by
appropriate risk analysis and that the verification and validation
testing, as appropriate, demonstrated that the design outputs met the
design input requirements. If another method of assessment was used, the
notice shall include a summary of the information which served as the
credible information supporting the change.
(B) For a protocol change, the notice shall include a description of
the change (cross-referenced to the appropriate sections of the original
protocol); an assessment supporting the conclusion that the change does
not have a significant impact on the study design or planned statistical
analysis; and a summary of the information that served as the credible
information supporting the sponsor's determination that the change does
not affect the rights, safety, or welfare of the subjects.
(4) Changes submitted in annual report. The requirements of
paragraph (a)(1) of this section do not apply to minor changes to the
purpose of the study, risk analysis, monitoring procedures, labeling,
informed consent materials, and IRB information that do not affect:
(i) The validity of the data or information resulting from the
completion of the approved protocol, or the relationship of likely
patient risk to benefit relied upon to approve the protocol;
(ii) The scientific soundness of the investigational plan; or
(iii) The rights, safety, or welfare of the human subjects involved
in the investigation. Such changes shall be reported in the annual
progress report for the IDE, under Sec. 812.150(b)(5).
(b) IRB approval for new facilities. A sponsor shall submit to FDA a
certification of any IRB approval of an investigation or a part of an
investigation not included in the IDE application. If the investigation
is otherwise unchanged, the supplemental application shall consist of an
updating of the information required by Sec. 812.20(b) and (c) and a
description of any modifications in the investigational plan required by
the IRB as a condition of approval. A certification of IRB approval need
not be included in the initial submission of the supplemental
application, and such certification is not a precondition for agency
consideration of the application. Nevertheless, a sponsor may not begin
a part of an investigation at a facility until the IRB has approved the
investigation, FDA has received the certification of IRB approval, and
FDA,
[[Page 127]]
under Sec. 812.30(a), has approved the supplemental application
relating to that part of the investigation (see Sec. 56.103(a)).
[50 FR 25909, June 24, 1985; 50 FR 28932, July 17, 1985, as amended at
61 FR 51531, Oct. 2, 1996; 63 FR 64625, Nov. 23, 1998]
Sec. 812.36 Treatment use of an investigational device.
(a) General. A device that is not approved for marketing may be
under clinical investigation for a serious or immediately life-
threatening disease or condition in patients for whom no comparable or
satisfactory alternative device or other therapy is available. During
the clinical trial or prior to final action on the marketing
application, it may be appropriate to use the device in the treatment of
patients not in the trial under the provisions of a treatment
investigational device exemption (IDE). The purpose of this section is
to facilitate the availability of promising new devices to desperately
ill patients as early in the device development process as possible,
before general marketing begins, and to obtain additional data on the
device's safety and effectiveness. In the case of a serious disease, a
device ordinarily may be made available for treatment use under this
section after all clinical trials have been completed. In the case of an
immediately life-threatening disease, a device may be made available for
treatment use under this section prior to the completion of all clinical
trials. For the purpose of this section, an ``immediately life-
threatening'' disease means a stage of a disease in which there is a
reasonable likelihood that death will occur within a matter of months or
in which premature death is likely without early treatment. For purposes
of this section, ``treatment use''of a device includes the use of a
device for diagnostic purposes.
(b) Criteria. FDA shall consider the use of an investigational
device under a treatment IDE if:
(1) The device is intended to treat or diagnose a serious or
immediately life-threatening disease or condition;
(2) There is no comparable or satisfactory alternative device or
other therapy available to treat or diagnose that stage of the disease
or condition in the intended patient population;
(3) The device is under investigation in a controlled clinical trial
for the same use under an approved IDE, or such clinical trials have
been completed; and
(4) The sponsor of the investigation is actively pursuing marketing
approval/clearance of the investigational device with due diligence.
(c) Applications for treatment use. (1) A treatment IDE application
shall include, in the following order:
(i) The name, address, and telephone number of the sponsor of the
treatment IDE;
(ii) The intended use of the device, the criteria for patient
selection, and a written protocol describing the treatment use;
(iii) An explanation of the rationale for use of the device,
including, as appropriate, either a list of the available regimens that
ordinarily should be tried before using the investigational device or an
explanation of why the use of the investigational device is preferable
to the use of available marketed treatments;
(iv) A description of clinical procedures, laboratory tests, or
other measures that will be used to evaluate the effects of the device
and to minimize risk;
(v) Written procedures for monitoring the treatment use and the name
and address of the monitor;
(vi) Instructions for use for the device and all other labeling as
required under Sec. 812.5(a) and (b);
(vii) Information that is relevant to the safety and effectiveness
of the device for the intended treatment use. Information from other
IDE's may be incorporated by reference to support the treatment use;
(viii) A statement of the sponsor's commitment to meet all
applicable responsibilities under this part and part 56 of this chapter
and to ensure compliance of all participating investigators with the
informed consent requirements of part 50 of this chapter;
(ix) An example of the agreement to be signed by all investigators
participating in the treatment IDE and certification that no
investigator will be
[[Page 128]]
added to the treatment IDE before the agreement is signed; and
(x) If the device is to be sold, the price to be charged and a
statement indicating that the price is based on manufacturing and
handling costs only.
(2) A licensed practitioner who receives an investigational device
for treatment use under a treatment IDE is an ``investigator'' under the
IDE and is responsible for meeting all applicable investigator
responsibilities under this part and parts 50 and 56 of this chapter.
(d) FDA action on treatment IDE applications--(1) Approval of
treatment IDE's. Treatment use may begin 30 days after FDA receives the
treatment IDE submission at the address specified in Sec. 812.19,
unless FDA notifies the sponsor in writing earlier than the 30 days that
the treatment use may or may not begin. FDA may approve the treatment
use as proposed or approve it with modifications.
(2) Disapproval or withdrawal of approval of treatment IDE's. FDA
may disapprove or withdraw approval of a treatment IDE if:
(i) The criteria specified in Sec. 812.36(b) are not met or the
treatment IDE does not contain the information required in Sec.
812.36(c);
(ii) FDA determines that any of the grounds for disapproval or
withdrawal of approval listed in Sec. 812.30(b)(1) through (b)(5)
apply;
(iii) The device is intended for a serious disease or condition and
there is insufficient evidence of safety and effectiveness to support
such use;
(iv) The device is intended for an immediately life-threatening
disease or condition and the available scientific evidence, taken as a
whole, fails to provide a reasonable basis for concluding that the
device:
(A) May be effective for its intended use in its intended
population; or
(B) Would not expose the patients to whom the device is to be
administered to an unreasonable and significant additional risk of
illness or injury;
(v) There is reasonable evidence that the treatment use is impeding
enrollment in, or otherwise interfering with the conduct or completion
of, a controlled investigation of the same or another investigational
device;
(vi) The device has received marketing approval/clearance or a
comparable device or therapy becomes available to treat or diagnose the
same indication in the same patient population for which the
investigational device is being used;
(vii) The sponsor of the controlled clinical trial is not pursuing
marketing approval/clearance with due diligence;
(viii) Approval of the IDE for the controlled clinical investigation
of the device has been withdrawn; or
(ix) The clinical investigator(s) named in the treatment IDE are not
qualified by reason of their scientific training and/or experience to
use the investigational device for the intended treatment use.
(3) Notice of disapproval or withdrawal. If FDA disapproves or
proposes to withdraw approval of a treatment IDE, FDA will follow the
procedures set forth in Sec. 812.30(c).
(e) Safeguards. Treatment use of an investigational device is
conditioned upon the sponsor and investigators complying with the
safeguards of the IDE process and the regulations governing informed
consent (part 50 of this chapter) and institutional review boards (part
56 of this chapter).
(f) Reporting requirements. The sponsor of a treatment IDE shall
submit progress reports on a semi-annual basis to all reviewing IRB's
and FDA until the filing of a marketing application. These reports shall
be based on the period of time since initial approval of the treatment
IDE and shall include the number of patients treated with the device
under the treatment IDE, the names of the investigators participating in
the treatment IDE, and a brief description of the sponsor's efforts to
pursue marketing approval/clearance of the device. Upon filing of a
marketing application, progress reports shall be submitted annually in
accordance with Sec. 812.150(b)(5). The sponsor of a treatment IDE is
responsible for submitting all other reports required under Sec.
812.150.
[62 FR 48947, Sept. 18, 1997]
[[Page 129]]
Sec. 812.38 Confidentiality of data and information.
(a) Existence of IDE. FDA will not disclose the existence of an IDE
unless its existence has previously been publicly disclosed or
acknowledged, until FDA approves an application for premarket approval
of the device subject to the IDE; or a notice of completion of a product
development protocol for the device has become effective.
(b) Availability of summaries or data. (1) FDA will make publicly
available, upon request, a detailed summary of information concerning
the safety and effectiveness of the device that was the basis for an
order approving, disapproving, or withdrawing approval of an application
for an IDE for a banned device. The summary shall include information on
any adverse effect on health caused by the device.
(2) If a device is a banned device or if the existence of an IDE has
been publicly disclosed or acknowledged, data or information contained
in the file is not available for public disclosure before approval of an
application for premarket approval or the effective date of a notice of
completion of a product development protocol except as provided in this
section. FDA may, in its discretion, disclose a summary of selected
portions of the safety and effectiveness data, that is, clinical,
animal, or laboratory studies and tests of the device, for public
consideration of a specific pending issue.
(3) If the existence of an IDE file has not been publicly disclosed
or acknowledged, no data or information in the file are available for
public disclosure except as provided in paragraphs (b)(1) and (c) of
this section.
(4) Notwithstanding paragraph (b)(2) of this section, FDA will make
available to the public, upon request, the information in the IDE that
was required to be filed in Docket Number 95S-0158 in the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852, for investigations involving an
exception from informed consent under Sec. 50.24 of this chapter.
Persons wishing to request this information shall submit a request under
the Freedom of Information Act.
(c) Reports of adverse effects. Upon request or on its own
initiative, FDA shall disclose to an individual on whom an
investigational device has been used a copy of a report of adverse
device effects relating to that use.
(d) Other rules. Except as otherwise provided in this section, the
availability for public disclosure of data and information in an IDE
file shall be handled in accordance with Sec. 814.9.
[45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 61
FR 51531, Oct. 2, 1996]
Subpart C_Responsibilities of Sponsors
Sec. 812.40 General responsibilities of sponsors.
Sponsors are responsible for selecting qualified investigators and
providing them with the information they need to conduct the
investigation properly, ensuring proper monitoring of the investigation,
ensuring that IRB review and approval are obtained, submitting an IDE
application to FDA, and ensuring that any reviewing IRB and FDA are
promptly informed of significant new information about an investigation.
Additional responsibilities of sponsors are described in subparts B and
G.
Sec. 812.42 FDA and IRB approval.
A sponsor shall not begin an investigation or part of an
investigation until an IRB and FDA have both approved the application or
supplemental application relating to the investigation or part of an
investigation.
[46 FR 8957, Jan. 27, 1981]
Sec. 812.43 Selecting investigators and monitors.
(a) Selecting investigators. A sponsor shall select investigators
qualified by training and experience to investigate the device.
(b) Control of device. A sponsor shall ship investigational devices
only to qualified investigators participating in the investigation.
(c) Obtaining agreements. A sponsor shall obtain from each
participating investigator a signed agreement that includes:
[[Page 130]]
(1) The investigator's curriculum vitae.
(2) Where applicable, a statement of the investigator's relevant
experience, including the dates, location, extent, and type of
experience.
(3) If the investigator was involved in an investigation or other
research that was terminated, an explanation of the circumstances that
led to termination.
(4) A statement of the investigator's commitment to:
(i) Conduct the investigation in accordance with the agreement, the
investigational plan, this part and other applicable FDA regulations,
and conditions of approval imposed by the reviewing IRB or FDA;
(ii) Supervise all testing of the device involving human subjects;
and
(iii) Ensure that the requirements for obtaining informed consent
are met.
(5) Sufficient accurate financial disclosure information to allow
the sponsor to submit a complete and accurate certification or
disclosure statement as required under part 54 of this chapter. The
sponsor shall obtain a commitment from the clinical investigator to
promptly update this information if any relevant changes occur during
the course of the investigation and for 1 year following completion of
the study. This information shall not be submitted in an investigational
device exemption application, but shall be submitted in any marketing
application involving the device.
(d) Selecting monitors. A sponsor shall select monitors qualified by
training and experience to monitor the investigational study in
accordance with this part and other applicable FDA regulations.
[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]
Sec. 812.45 Informing investigators.
A sponsor shall supply all investigators participating in the
investigation with copies of the investigational plan and the report of
prior investigations of the device.
Sec. 812.46 Monitoring investigations.
(a) Securing compliance. A sponsor who discovers that an
investigator is not complying with the signed agreement, the
investigational plan, the requirements of this part or other applicable
FDA regulations, or any conditions of approval imposed by the reviewing
IRB or FDA shall promptly either secure compliance, or discontinue
shipments of the device to the investigator and terminate the
investigator's participation in the investigation. A sponsor shall also
require such an investigator to dispose of or return the device, unless
this action would jeopardize the rights, safety, or welfare of a
subject.
(b) Unanticipated adverse device effects. (1) A sponsor shall
immediately conduct an evaluation of any unanticipated adverse device
effect.
(2) A sponsor who determines that an unanticipated adverse device
effect presents an unreasonable risk to subjects shall terminate all
investigations or parts of investigations presenting that risk as soon
as possible. Termination shall occur not later than 5 working days after
the sponsor makes this determination and not later than 15 working days
after the sponsor first received notice of the effect.
(c) Resumption of terminated studies. If the device is a significant
risk device, a sponsor may not resume a terminated investigation without
IRB and FDA approval. If the device is not a significant risk device, a
sponsor may not resume a terminated investigation without IRB approval
and, if the investigation was terminated under paragraph (b)(2) of this
section, FDA approval.
Sec. 812.47 Emergency research under Sec. 50.24 of this chapter.
(a) The sponsor shall monitor the progress of all investigations
involving an exception from informed consent under Sec. 50.24 of this
chapter. When the sponsor receives from the IRB information concerning
the public disclosures under Sec. 50.24(a)(7)(ii) and (a)(7)(iii) of
this chapter, the sponsor shall promptly submit to the IDE file and to
Docket Number 95S-0158 in the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852, copies of the information that was disclosed, identified by the
IDE number.
(b) The sponsor also shall monitor such investigations to determine
when
[[Page 131]]
an IRB determines that it cannot approve the research because it does
not meet the criteria in the exception in Sec. 50.24(a) of this chapter
or because of other relevant ethical concerns. The sponsor promptly
shall provide this information in writing to FDA, investigators who are
asked to participate in this or a substantially equivalent clinical
investigation, and other IRB's that are asked to review this or a
substantially equivalent investigation.
[61 FR 51531, Oct. 2, 1996, as amended at 64 FR 10943, Mar. 8, 1999]
Subpart D_IRB Review and Approval
Sec. 812.60 IRB composition, duties, and functions.
An IRB reviewing and approving investigations under this part shall
comply with the requirements of part 56 in all respects, including its
composition, duties, and functions.
[46 FR 8957, Jan. 27, 1981]
Sec. 812.62 IRB approval.
(a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all investigations
covered by this part.
(b) If no IRB exists or if FDA finds that an IRB's review is
inadequate, a sponsor may submit an application to FDA.
[46 FR 8957, Jan. 27, 1981]
Sec. 812.64 IRB's continuing review.
The IRB shall conduct its continuing review of an investigation in
accordance with part 56.
[46 FR 8957, Jan. 27, 1981]
Sec. 812.65 [Reserved]
Sec. 812.66 Significant risk device determinations.
If an IRB determines that an investigation, presented for approval
under Sec. 812.2(b)(1)(ii), involves a significant risk device, it
shall so notify the investigator and, where appropriate, the sponsor. A
sponsor may not begin the investigation except as provided in Sec.
812.30(a).
[46 FR 8957, Jan. 27, 1981]
Subpart E_Responsibilities of Investigators
Sec. 812.100 General responsibilities of investigators.
An investigator is responsible for ensuring that an investigation is
conducted according to the signed agreement, the investigational plan
and applicable FDA regulations, for protecting the rights, safety, and
welfare of subjects under the investigator's care, and for the control
of devices under investigation. An investigator also is responsible for
ensuring that informed consent is obtained in accordance with part 50 of
this chapter. Additional responsibilities of investigators are described
in subpart G.
[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]
Sec. 812.110 Specific responsibilities of investigators.
(a) Awaiting approval. An investigator may determine whether
potential subjects would be interested in participating in an
investigation, but shall not request the written informed consent of any
subject to participate, and shall not allow any subject to participate
before obtaining IRB and FDA approval.
(b) Compliance. An investigator shall conduct an investigation in
accordance with the signed agreement with the sponsor, the
investigational plan, this part and other applicable FDA regulations,
and any conditions of approval imposed by an IRB or FDA.
(c) Supervising device use. An investigator shall permit an
investigational device to be used only with subjects under the
investigator's supervision. An investigator shall not supply an
investigational device to any person not authorized under this part to
receive it.
(d) Financial disclosure. A clinical investigator shall disclose to
the sponsor sufficient accurate financial information to allow the
applicant to submit complete and accurate certification or disclosure
statements required under
[[Page 132]]
part 54 of this chapter. The investigator shall promptly update this
information if any relevant changes occur during the course of the
investigation and for 1 year following completion of the study.
(e) Disposing of device. Upon completion or termination of a
clinical investigation or the investigator's part of an investigation,
or at the sponsor's request, an investigator shall return to the sponsor
any remaining supply of the device or otherwise dispose of the device as
the sponsor directs.
[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]
Sec. 812.119 Disqualification of a clinical investigator.
(a) If FDA has information indicating that an investigator
(including a sponsor-investigator) has repeatedly or deliberately failed
to comply with the requirements of this part, part 50, or part 56 of
this chapter, or has repeatedly or deliberately submitted to FDA or to
the sponsor false information in any required report, the Center for
Devices and Radiological Health, the Center for Biologics Evaluation and
Research, or the Center for Drug Evaluation and Research will furnish
the investigator written notice of the matter complained of and offer
the investigator an opportunity to explain the matter in writing, or, at
the option of the investigator, in an informal conference. If an
explanation is offered and accepted by the applicable Center, the Center
will discontinue the disqualification proceeding. If an explanation is
offered but not accepted by the applicable Center, the investigator will
be given an opportunity for a regulatory hearing under part 16 of this
chapter on the question of whether the investigator is eligible to
receive test articles under this part and eligible to conduct any
clinical investigation that supports an application for a research or
marketing permit for products regulated by FDA.
(b) After evaluating all available information, including any
explanation presented by the investigator, if the Commissioner
determines that the investigator has repeatedly or deliberately failed
to comply with the requirements of this part, part 50, or part 56 of
this chapter, or has repeatedly or deliberately submitted to FDA or to
the sponsor false information in any required report, the Commissioner
will notify the investigator, the sponsor of any investigation in which
the investigator has been named as a participant, and the reviewing
investigational review boards (IRBs) that the investigator is not
eligible to receive test articles under this part. The notification to
the investigator, sponsor and IRBs will provide a statement of the basis
for such determination. The notification also will explain that an
investigator determined to be ineligible to receive test articles under
this part will be ineligible to conduct any clinical investigation that
supports an application for a research or marketing permit for products
regulated by FDA, including drugs, biologics, devices, new animal drugs,
foods, including dietary supplements, that bear a nutrient content claim
or a health claim, infant formulas, food and color additives, and
tobacco products.
(c) Each application or submission to FDA under the provisions of
this chapter containing data reported by an investigator who has been
determined to be ineligible to receive FDA-regulated test articles is
subject to examination to determine whether the investigator has
submitted unreliable data that are essential to the continuation of an
investigation or essential to the clearance or approval of a marketing
application, or essential to the continued marketing of an FDA-regulated
product.
(d) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the data remaining are inadequate to support a conclusion that it is
reasonably safe to continue the investigation, the Commissioner will
notify the sponsor, who shall have an opportunity for a regulatory
hearing under part 16 of this chapter. If a danger to the public health
exists, however, the Commissioner shall terminate the investigational
device exemption (IDE) immediately and notify the sponsor and the
reviewing IRBs of the termination. In such case, the sponsor shall have
an opportunity for a regulatory hearing before FDA under part 16 of this
chapter on the question of
[[Page 133]]
whether the IDE should be reinstated. The determination that an
investigation may not be considered in support of a research or
marketing application or a notification or petition submission does not,
however, relieve the sponsor of any obligation under any other
applicable regulation to submit to FDA the results of the investigation.
(e) If the Commissioner determines, after the unreliable data
submitted by the investigator are eliminated from consideration, that
the continued clearance or approval of the product for which the data
were submitted cannot be justified, the Commissioner will proceed to
rescind clearance or withdraw approval of the product in accordance with
the applicable provisions of the relevant statutes.
(f) An investigator who has been determined to be ineligible under
paragraph (b) of this section may be reinstated as eligible when the
Commissioner determines that the investigator has presented adequate
assurances that the investigator will employ all test articles, and will
conduct any clinical investigation that supports an application for a
research or marketing permit for products regulated by FDA, solely in
compliance with the applicable provisions of this chapter.
[77 FR 25360, Apr. 30, 2012]
Subpart F [Reserved]
Subpart G_Records and Reports
Sec. 812.140 Records.
(a) Investigator records. A participating investigator shall
maintain the following accurate, complete, and current records relating
to the investigator's participation in an investigation:
(1) All correspondence with another investigator, an IRB, the
sponsor, a monitor, or FDA, including required reports.
(2) Records of receipt, use or disposition of a device that relate
to:
(i) The type and quantity of the device, the dates of its receipt,
and the batch number or code mark.
(ii) The names of all persons who received, used, or disposed of
each device.
(iii) Why and how many units of the device have been returned to the
sponsor, repaired, or otherwise disposed of.
(3) Records of each subject's case history and exposure to the
device. Case histories include the case report forms and supporting data
including, for example, signed and dated consent forms and medical
records including, for example, progress notes of the physician, the
individual's hospital chart(s), and the nurses' notes. Such records
shall include:
(i) Documents evidencing informed consent and, for any use of a
device by the investigator without informed consent, any written
concurrence of a licensed physician and a brief description of the
circumstances justifying the failure to obtain informed consent. The
case history for each individual shall document that informed consent
was obtained prior to participation in the study.
(ii) All relevant observations, including records concerning adverse
device effects (whether anticipated or unanticipated), information and
data on the condition of each subject upon entering, and during the
course of, the investigation, including information about relevant
previous medical history and the results of all diagnostic tests.
(iii) A record of the exposure of each subject to the
investigational device, including the date and time of each use, and any
other therapy.
(4) The protocol, with documents showing the dates of and reasons
for each deviation from the protocol.
(5) Any other records that FDA requires to be maintained by
regulation or by specific requirement for a category of investigations
or a particular investigation.
(b) Sponsor records. A sponsor shall maintain the following
accurate, complete, and current records relating to an investigation:
(1) All correspondence with another sponsor, a monitor, an
investigator, an IRB, or FDA, including required reports.
(2) Records of shipment and disposition. Records of shipment shall
include the name and address of the consignee, type and quantity of
device, date of shipment, and batch number or code
[[Page 134]]
mark. Records of disposition shall describe the batch number or code
marks of any devices returned to the sponsor, repaired, or disposed of
in other ways by the investigator or another person, and the reasons for
and method of disposal.
(3) Signed investigator agreements including the financial
disclosure information required to be collected under Sec. 812.43(c)(5)
in accordance with part 54 of this chapter.
(4) For each investigation subject to Sec. 812.2(b)(1) of a device
other than a significant risk device, the records described in paragraph
(b)(5) of this section and the following records, consolidated in one
location and available for FDA inspection and copying:
(i) The name and intended use of the device and the objectives of
the investigation;
(ii) A brief explanation of why the device is not a significant risk
device:
(iii) The name and address of each investigator:
(iv) The name and address of each IRB that has reviewed the
investigation:
(v) A statement of the extent to which the good manufacturing
practice regulation in part 820 will be followed in manufacturing the
device; and
(vi) Any other information required by FDA.
(5) Records concerning adverse device effects (whether anticipated
or unanticipated) and complaints and
(6) Any other records that FDA requires to be maintained by
regulation or by specific requirement for a category of investigation or
a particular investigation.
(c) IRB records. An IRB shall maintain records in accordance with
part 56 of this chapter.
(d) Retention period. An investigator or sponsor shall maintain the
records required by this subpart during the investigation and for a
period of 2 years after the latter of the following two dates: The date
on which the investigation is terminated or completed, or the date that
the records are no longer required for purposes of supporting a
premarket approval application, a notice of completion of a product
development protocol, a humanitarian device exemption application, a
premarket notification submission, or a request for De Novo
classification.
(e) Records custody. An investigator or sponsor may withdraw from
the responsibility to maintain records for the period required in
paragraph (d) of this section and transfer custody of the records to any
other person who will accept responsibility for them under this part,
including the requirements of Sec. 812.145. Notice of a transfer shall
be given to FDA not later than 10 working days after transfer occurs.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 46
FR 8957, Jan. 27, 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. 2,
1998; 83 FR 7387, Feb. 21, 2018; 83 FR 7387, Feb. 21, 2018]
Sec. 812.145 Inspections.
(a) Entry and inspection. A sponsor or an investigator who has
authority to grant access shall permit authorized FDA employees, at
reasonable times and in a reasonable manner, to enter and inspect any
establishment where devices are held (including any establishment where
devices are manufactured, processed, packed, installed, used, or
implanted or where records of results from use of devices are kept).
(b) Records inspection. A sponsor, IRB, or investigator, or any
other person acting on behalf of such a person with respect to an
investigation, shall permit authorized FDA employees, at reasonable
times and in a reasonable manner, to inspect and copy all records
relating to an investigation.
(c) Records identifying subjects. An investigator shall permit
authorized FDA employees to inspect and copy records that identify
subjects, upon notice that FDA has reason to suspect that adequate
informed consent was not obtained, or that reports required to be
submitted by the investigator to the sponsor or IRB have not been
submitted or are incomplete, inaccurate, false, or misleading.
Sec. 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit
the following complete, accurate, and timely reports:
(1) Unanticipated adverse device effects. An investigator shall
submit to the
[[Page 135]]
sponsor and to the reviewing IRB a report of any unanticipated adverse
device effect occurring during an investigation as soon as possible, but
in no event later than 10 working days after the investigator first
learns of the effect.
(2) Withdrawal of IRB approval. An investigator shall report to the
sponsor, within 5 working days, a withdrawal of approval by the
reviewing IRB of the investigator's part of an investigation.
(3) Progress. An investigator shall submit progress reports on the
investigation to the sponsor, the monitor, and the reviewing IRB at
regular intervals, but in no event less often than yearly.
(4) Deviations from the investigational plan. An investigator shall
notify the sponsor and the reviewing IRB (see Sec. 56.108(a) (3) and
(4)) of any deviation from the investigational plan to protect the life
or physical well-being of a subject in an emergency. Such notice shall
be given as soon as possible, but in no event later than 5 working days
after the emergency occurred. Except in such an emergency, prior
approval by the sponsor is required for changes in or deviations from a
plan, and if these changes or deviations may affect the scientific
soundness of the plan or the rights, safety, or welfare of human
subjects, FDA and IRB in accordance with Sec. 812.35(a) also is
required.
(5) Informed consent. If an investigator uses a device without
obtaining informed consent, the investigator shall report such use to
the sponsor and the reviewing IRB within 5 working days after the use
occurs.
(6) Final report. An investigator shall, within 3 months after
termination or completion of the investigation or the investigator's
part of the investigation, submit a final report to the sponsor and the
reviewing IRB.
(7) Other. An investigator shall, upon request by a reviewing IRB or
FDA, provide accurate, complete, and current information about any
aspect of the investigation.
(b) Sponsor reports. A sponsor shall prepare and submit the
following complete, accurate, and timely reports:
(1) Unanticipated adverse device effects. A sponsor who conducts an
evaluation of an unanticipated adverse device effect under Sec.
812.46(b) shall report the results of such evaluation to FDA and to all
reviewing IRB's and participating investigators within 10 working days
after the sponsor first receives notice of the effect. Thereafter the
sponsor shall submit such additional reports concerning the effect as
FDA requests.
(2) Withdrawal of IRB approval. A sponsor shall notify FDA and all
reviewing IRB's and participating investigators of any withdrawal of
approval of an investigation or a part of an investigation by a
reviewing IRB within 5 working days after receipt of the withdrawal of
approval.
(3) Withdrawal of FDA approval. A sponsor shall notify all reviewing
IRB's and participating investigators of any withdrawal of FDA approval
of the investigation, and shall do so within 5 working days after
receipt of notice of the withdrawal of approval.
(4) Current investigator list. A sponsor shall submit to FDA, at 6-
month intervals, a current list of the names and addresses of all
investigators participating in the investigation. The sponsor shall
submit the first such list 6 months after FDA approval.
(5) Progress reports. At regular intervals, and at least yearly, a
sponsor shall submit progress reports to all reviewing IRB's. In the
case of a significant risk device, a sponsor shall also submit progress
reports to FDA. A sponsor of a treatment IDE shall submit semi-annual
progress reports to all reviewing IRB's and FDA in accordance with Sec.
812.36(f) and annual reports in accordance with this section.
(6) Recall and device disposition. A sponsor shall notify FDA and
all reviewing IRB's of any request that an investigator return, repair,
or otherwise dispose of any units of a device. Such notice shall occur
within 30 working days after the request is made and shall state why the
request was made.
(7) Final report. In the case of a significant risk device, the
sponsor shall notify FDA within 30 working days of the completion or
termination of the investigation and shall submit a final report to FDA
and all reviewing the IRB's and participating investigators within 6
months after completion or termination. In the case of a device that is
not a significant risk device,
[[Page 136]]
the sponsor shall submit a final report to all reviewing IRB's within 6
months after termination or completion.
(8) Informed consent. A sponsor shall submit to FDA a copy of any
report by an investigator under paragraph (a)(5) of this section of use
of a device without obtaining informed consent, within 5 working days of
receipt of notice of such use.
(9) Significant risk device determinations. If an IRB determines
that a device is a significant risk device, and the sponsor had proposed
that the IRB consider the device not to be a significant risk device,
the sponsor shall submit to FDA a report of the IRB's determination
within 5 working days after the sponsor first learns of the IRB's
determination.
(10) Other. A sponsor shall, upon request by a reviewing IRB or FDA,
provide accurate, complete, and current information about any aspect of
the investigation.
[45 FR 3751, Jan. 18, 1980, as amended at 45 FR 58843, Sept. 5, 1980; 48
FR 15622, Apr. 12, 1983; 62 FR 48948, Sept. 18, 1997]
PART 813 [RESERVED]
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
Subpart A_General
Sec.
814.1 Scope.
814.2 Purpose.
814.3 Definitions.
814.9 Confidentiality of data and information in a premarket approval
application (PMA) file.
814.15 Research conducted outside the United States.
814.17 Service of orders.
814.19 Product development protocol (PDP).
Subpart B_Premarket Approval Application (PMA)
814.20 Application.
814.37 PMA amendments and resubmitted PMAs.
814.39 PMA supplements.
Subpart C_FDA Action on a PMA
814.40 Time frames for reviewing a PMA.
814.42 Filing a PMA.
814.44 Procedures for review of a PMA.
814.45 Denial of approval of a PMA.
814.46 Withdrawal of approval of a PMA.
814.47 Temporary suspension of approval of a PMA.
Subpart D--Administrative Review [Reserved]
Subpart E_Postapproval Requirements
814.80 General.
814.82 Postapproval requirements.
814.84 Reports.
Subparts F-G [Reserved]
Subpart H_Humanitarian Use Devices
814.100 Purpose and scope.
814.102 Designation of HUD status.
814.104 Original applications.
814.106 HDE amendments and resubmitted HDE's.
814.108 Supplemental applications.
814.110 New indications for use.
814.112 Filing an HDE.
814.114 Timeframes for reviewing an HDE.
814.116 Procedures for review of an HDE.
814.118 Denial of approval or withdrawal of approval of an HDE.
814.120 Temporary suspension of approval of an HDE.
814.122 Confidentiality of data and information.
814.124 Institutional Review Board requirements.
814.126 Postapproval requirements and reports.
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 371,
372, 373, 374, 375, 379, 379e, 379k-1, 381.
Source: 51 FR 26364, July 22, 1986, unless otherwise noted.
Subpart A_General
Sec. 814.1 Scope.
(a) This section implements sections 515 and 515A of the act by
providing procedures for the premarket approval of medical devices
intended for human use.
(b) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
(c) This part applies to any class III medical device, unless exempt
under section 520(g) of the act, that:
(1) Was not on the market (introduced or delivered for introduction
into commerce for commercial distribution) before May 28, 1976, and is
not substantially equivalent to a device on the
[[Page 137]]
market before May 28, 1976, or to a device first marketed on, or after
that date, which has been classified into class I or class II; or
(2) Is required to have an approved premarket approval application
(PMA) or a declared completed product development protocol under a
regulation issued under section 515(b) of the act; or
(3) Was regulated by FDA as a new drug or antibiotic drug before May
28, 1976, and therefore is governed by section 520(1) of the act.
(d) This part amends the conditions to approval for any PMA approved
before the effective date of this part. Any condition to approval for an
approved PMA that is inconsistent with this part is revoked. Any
condition to approval for an approved PMA that is consistent with this
part remains in effect.
[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]
Sec. 814.2 Purpose.
The purpose of this part is to establish an efficient and thorough
device review process--
(a) To facilitate the approval of PMA's for devices that have been
shown to be safe and effective and that otherwise meet the statutory
criteria for approval; and
(b) To ensure the disapproval of PMA's for devices that have not
been shown to be safe and effective or that do not otherwise meet the
statutory criteria for approval. This part shall be construed in light
of these objectives.
Sec. 814.3 Definitions.
For the purposes of this part:
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections
201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-392)).
(b) FDA means the Food and Drug Administration.
(c) IDE means an approved or considered approved investigational
device exemption under section 520(g) of the act and parts 812 and 813.
(d) Master file means a reference source that a person submits to
FDA. A master file may contain detailed information on a specific
manufacturing facility, process, methodology, or component used in the
manufacture, processing, or packaging of a medical device.
(e) PMA means any premarket approval application for a class III
medical device, including all information submitted with or incorporated
by reference therein. ``PMA'' includes a new drug application for a
device under section 520(1) of the act.
(f) PMA amendment means information an applicant submits to FDA to
modify a pending PMA or a pending PMA supplement.
(g) PMA supplement means a supplemental application to an approved
PMA for approval of a change or modification in a class III medical
device, including all information submitted with or incorporated by
reference therein.
(h) Person includes any individual, partnership, corporation,
association, scientific or academic establishment, Government agency, or
organizational unit thereof, or any other legal entity.
(i) Statement of material fact means a representation that tends to
show that the safety or effectiveness of a device is more probable than
it would be in the absence of such a representation. A false affirmation
or silence or an omission that would lead a reasonable person to draw a
particular conclusion as to the safety or effectiveness of a device also
may be a false statement of material fact, even if the statement was not
intended by the person making it to be misleading or to have any
probative effect.
(j) 30-day PMA supplement means a supplemental application to an
approved PMA in accordance with Sec. 814.39(e).
(k) Reasonable probability means that it is more likely than not
that an event will occur.
(l) Serious, adverse health consequences means any significant
adverse experience, including those which may be either life-threatening
or involve permanent or long term injuries, but excluding injuries that
are nonlife-threatening and that are temporary and reasonably
reversible.
(m) HDE means a premarket approval application submitted pursuant to
this subpart seeking a humanitarian device exemption from the
effectiveness requirements of sections 514 and 515 of
[[Page 138]]
the act as authorized by section 520(m)(2) of the act.
(n) HUD (humanitarian use device) means a medical device intended to
benefit patients in the treatment or diagnosis of a disease or condition
that affects or is manifested in not more than 8,000 individuals in the
United States per year.
(o) Newly acquired information means data, analyses, or other
information not previously submitted to the agency, which may include
(but are not limited to) data derived from new clinical studies, reports
of adverse events, or new analyses of previously submitted data (e.g.,
meta-analyses) if the studies, events or analyses reveal risks of a
different type or greater severity or frequency than previously included
in submissions to FDA.
(p) Human cell, tissue, or cellular or tissue-based product (HCT/P)
regulated as a device means an HCT/P as defined in Sec. 1271.3(d) of
this chapter that does not meet the criteria in Sec. 1271.10(a) and
that is also regulated as a device.
(q) Unique device identifier (UDI) means an identifier that
adequately identifies a device through its distribution and use by
meeting the requirements of Sec. 830.20 of this chapter. A unique
device identifier is composed of:
(1) A device identifier--a mandatory, fixed portion of a UDI that
identifies the specific version or model of a device and the labeler of
that device; and
(2) A production identifier--a conditional, variable portion of a
UDI that identifies one or more of the following when included on the
label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.
(v) For an HCT/P regulated as a device, the distinct identification
code required by Sec. 1271.290(c) of this chapter.
(r) Universal product code (UPC) means the product identifier used
to identify an item sold at retail in the United States.
(s) Pediatric patients means patients who are 21 years of age or
younger (that is, from birth through the twenty-first year of life, up
to but not including the twenty-second birthday) at the time of the
diagnosis or treatment.
(t) Readily available means available in the public domain through
commonly used public resources for conducting biomedical, regulatory,
and medical product research.
[51 FR 26364, July 22, 1986, as amended at 61 FR 15190, Apr. 5, 1996; 61
FR 33244, June 26, 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 58821, Sept.
24, 2013; 79 FR 1740, Jan. 10, 2014; 82 FR 26349, June 7, 2017]
Sec. 814.9 Confidentiality of data and information in a premarket
approval application (PMA) file.
(a) A ``PMA file'' includes all data and information submitted with
or incorporated by reference in the PMA, any IDE incorporated into the
PMA, any PMA supplement, any report under Sec. 814.82, any master file,
or any other related submission. Any record in the PMA file will be
available for public disclosure in accordance with the provisions of
this section and part 20. The confidentiality of information in a color
additive petition submitted as part of a PMA is governed by Sec. 71.15.
(b) The existence of a PMA file may not be disclosed by FDA before
an approval order is issued to the applicant unless it previously has
been publicly disclosed or acknowledged.
(c) If the existence of a PMA file has not been publicly disclosed
or acknowledged, data or information in the PMA file are not available
for public disclosure.
(d)(1) If the existence of a PMA file has been publicly disclosed or
acknowledged before an order approving, or an order denying approval of
the PMA is issued, data or information contained in the file are not
available for public disclosure before such order issues. FDA may,
however, disclose a summary of portions of the safety and effectiveness
data before an approval order or an order denying approval of the PMA
issues if disclosure is relevant to public consideration of a specific
pending issue.
(2) Notwithstanding paragraph (d)(1) of this section, FDA will make
available to the public upon request the information in the IDE that was
required
[[Page 139]]
to be filed in Docket Number 95S-0158 in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 12420 Parklawn Dr.,
rm. 1-23, Rockville, MD 20857, for investigations involving an exception
from informed consent under Sec. 50.24 of this chapter. Persons wishing
to request this information shall submit a request under the Freedom of
Information Act.
(e) Upon issuance of an order approving, or an order denying
approval of any PMA, FDA will make available to the public the fact of
the existence of the PMA and a detailed summary of information submitted
to FDA respecting the safety and effectiveness of the device that is the
subject of the PMA and that is the basis for the order.
(f) After FDA issues an order approving, or an order denying
approval of any PMA, the following data and information in the PMA file
are immediately available for public disclosure:
(1) All safety and effectiveness data and information previously
disclosed to the public, as such disclosure is defined in Sec. 20.81.
(2) Any protocol for a test or study unless the protocol is shown to
constitute trade secret or confidential commercial or financial
information under Sec. 20.61.
(3) Any adverse reaction report, product experience report, consumer
complaint, and other similar data and information, after deletion of:
(i) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61; and
(ii) Any personnel, medical, and similar information disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy under Sec. 20.63; provided, however, that except for the
information that constitutes trade secret or confidential commercial or
financial information under Sec. 20.61, FDA will disclose to a patient
who requests a report all the information in the report concerning that
patient.
(4) A list of components previously disclosed to the public, as such
disclosure is defined in Sec. 20.81.
(5) An assay method or other analytical method, unless it does not
serve any regulatory purpose and is shown to fall within the exemption
in Sec. 20.61 for trade secret or confidential commercial or financial
information.
(6) All correspondence and written summaries of oral discussions
relating to the PMA file, in accordance with the provisions of
Sec. Sec. 20.103 and 20.104.
(g) All safety and effectiveness data and other information not
previously disclosed to the public are available for public disclosure
if any one of the following events occurs and the data and information
do not constitute trade secret or confidential commercial or financial
information under Sec. 20.61:
(1) The PMA has been abandoned. FDA will consider a PMA abandoned
if:
(i)(A) The applicant fails to respond to a request for additional
information within 180 days after the date FDA issues the request or
(B) Other circumstances indicate that further work is not being
undertaken with respect to it, and
(ii) The applicant fails to communicate with FDA within 7 days after
the date on which FDA notifies the applicant that the PMA appears to
have been abandoned.
(2) An order denying approval of the PMA has issued, and all legal
appeals have been exhausted.
(3) An order withdrawing approval of the PMA has issued, and all
legal appeals have been exhausted.
(4) The device has been reclassified.
(5) The device has been found to be substantially equivalent to a
class I or class II device.
(6) The PMA is considered voluntarily withdrawn under Sec.
814.44(g).
(h) The following data and information in a PMA file are not
available for public disclosure unless they have been previously
disclosed to the public, as such disclosure is defined in Sec. 20.81,
or they relate to a device for which a PMA has been abandoned and they
no longer represent a trade secret or confidential commercial or
financial information as defined in Sec. 20.61:
(1) Manufacturing methods or processes, including quality control
procedures.
(2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal
[[Page 140]]
data or information which are not available for public disclosure under
this provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
[51 FR 26364, July 22, 1986, as amended at 61 FR 51531, Oct. 2, 1996]
Sec. 814.15 Research conducted outside the United States.
(a) Data to support PMA. If data from clinical investigations
conducted outside the United States are submitted to support a PMA, the
applicant shall comply with the provisions in Sec. 812.28 of this
chapter, as applicable.
(b) As sole basis for marketing approval. A PMA based solely on
foreign clinical data and otherwise meeting the criteria for approval
under this part may be approved if:
(1) The foreign data are applicable to the U.S. population and U.S.
medical practice;
(2) The studies have been performed by clinical investigators of
recognized competence; and
(3) The data may be considered valid without the need for an on-site
inspection by FDA or, if FDA considers such an inspection to be
necessary, FDA can validate the data through an on-site inspection or
other appropriate means.
(c) Consultation between FDA and applicants. Applicants are
encouraged to meet with FDA officials in a ``presubmission'' meeting
when approval based solely on foreign data will be sought.
[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51
FR 43344, Dec. 2, 1986; 83 FR 7387, Feb. 21, 2018]
Sec. 814.17 Service of orders.
Orders issued under this part will be served in person by a
designated officer or employee of FDA on, or by registered mail to, the
applicant or the designated agent at the applicant's or designated
agent's last known address in FDA's records.
Sec. 814.19 Product development protocol (PDP).
A class III device for which a product development protocol has been
declared completed by FDA under this chapter will be considered to have
an approved PMA.
Subpart B_Premarket Approval Application (PMA)
Sec. 814.20 Application.
(a) The applicant or an authorized representative shall sign the
PMA. If the applicant does not reside or have a place of business within
the United States, the PMA shall be countersigned by an authorized
representative residing or maintaining a place of business in the United
States and shall identify the representative's name and address.
(b) Unless the applicant justifies an omission in accordance with
paragraph (d) of this section, a PMA shall include in electronic format:
(1) The name and address of the applicant.
(2) A table of contents that specifies the volume and page number
for each item referred to in the table. A PMA shall include separate
sections on nonclinical laboratory studies and on clinical
investigations involving human subjects. A PMA shall be submitted as a
single version. The applicant shall include information that it believes
to be trade secret or confidential commercial or financial information
in the PMA and identify the information that it believes to be trade
secret or confidential commercial or financial information.
(3) A summary in sufficient detail that the reader may gain a
general understanding of the data and information in the application.
The summary shall contain the following information:
(i) Indications for use. A general description of the disease or
condition the device will diagnose, treat, prevent, cure, or mitigate,
including a description of the patient population for which the device
is intended.
(ii) Device description. An explanation of how the device functions,
the basic scientific concepts that form the basis for the device, and
the significant physical and performance characteristics of the device.
A brief description of the manufacturing process should be included if
it will significantly enhance the reader's understanding of the device.
The generic name of the device as
[[Page 141]]
well as any proprietary name or trade name should be included.
(iii) Alternative practices and procedures. A description of
existing alternative practices or procedures for diagnosing, treating,
preventing, curing, or mitigating the disease or condition for which the
device is intended.
(iv) Marketing history. A brief description of the foreign and U.S.
marketing history, if any, of the device, including a list of all
countries in which the device has been marketed and a list of all
countries in which the device has been withdrawn from marketing for any
reason related to the safety or effectiveness of the device. The
description shall include the history of the marketing of the device by
the applicant and, if known, the history of the marketing of the device
by any other person.
(v) Summary of studies. An abstract of any information or report
described in the PMA under paragraph (b)(8)(ii) of this section and a
summary of the results of technical data submitted under paragraph
(b)(6) of this section. Such summary shall include a description of the
objective of the study, a description of the experimental design of the
study, a brief description of how the data were collected and analyzed,
and a brief description of the results, whether positive, negative, or
inconclusive. This section shall include the following:
(A) A summary of the nonclinical laboratory studies submitted in the
application;
(B) A summary of the clinical investigations involving human
subjects submitted in the application including a discussion of subject
selection and exclusion criteria, study population, study period, safety
and effectiveness data, adverse reactions and complications, patient
discontinuation, patient complaints, device failures and replacements,
results of statistical analyses of the clinical investigations,
contraindications and precautions for use of the device, and other
information from the clinical investigations as appropriate (any
investigation conducted under an IDE shall be identified as such).
(vi) Conclusions drawn from the studies. A discussion demonstrating
that the data and information in the application constitute valid
scientific evidence within the meaning of Sec. 860.7 and provide
reasonable assurance that the device is safe and effective for its
intended use. A concluding discussion shall present benefit and risk
considerations related to the device including a discussion of any
adverse effects of the device on health and any proposed additional
studies or surveillance the applicant intends to conduct following
approval of the PMA.
(4) A complete description of:
(i) The device, including pictorial representations;
(ii) Each of the functional components or ingredients of the device
if the device consists of more than one physical component or
ingredient;
(iii) The properties of the device relevant to the diagnosis,
treatment, prevention, cure, or mitigation of a disease or condition;
(iv) The principles of operation of the device; and
(v) The methods used in, and the facilities and controls used for,
the manufacture, processing, packing, storage, and, where appropriate,
installation of the device, in sufficient detail so that a person
generally familiar with current good manufacturing practice can make a
knowledgeable judgment about the quality control used in the manufacture
of the device.
(5) Reference to any performance standard under section 514 of the
Federal Food, Drug, and Cosmetic Act or under section 534 of Subchapter
C--Electronic Product Radiation Control of the Federal Food, Drug, and
Cosmetic Act (formerly the Radiation Control for Health and Safety Act
of 1968) in effect or proposed at the time of the submission and to any
voluntary standard that is relevant to any aspect of the safety or
effectiveness of the device and that is known to or that should
reasonably be known to the applicant. The applicant shall--
(i) Provide adequate information to demonstrate how the device
meets, or justify any deviation from, any performance standard
established under section 514 of the Federal Food, Drug, and Cosmetic
Act or under section 534 of Subchapter C--Electronic Product Radiation
Control of the Federal Food,
[[Page 142]]
Drug, and Cosmetic Act (formerly the Radiation Control for Health and
Safety Act of 1968); and
(ii) Explain any deviation from a voluntary standard.
(6) The following technical sections which shall contain data and
information in sufficient detail to permit FDA to determine whether to
approve or deny approval of the application:
(i) A section containing results of the nonclinical laboratory
studies with the device including microbiological, toxicological,
immunological, biocompatibility, stress, wear, shelf life, and other
laboratory or animal tests as appropriate. Information on nonclinical
laboratory studies shall include a statement that each such study was
conducted in compliance with part 58, or, if the study was not conducted
in compliance with such regulations, a brief statement of the reason for
the noncompliance.
(ii) A section containing results of the clinical investigations
involving human subjects with the device including clinical protocols,
number of investigators and subjects per investigator, subject selection
and exclusion criteria, study population, study period, safety and
effectiveness data, adverse reactions and complications, patient
discontinuation, patient complaints, device failures and replacements,
tabulations of data from all individual subject report forms and copies
of such forms for each subject who died during a clinical investigation
or who did not complete the investigation, results of statistical
analyses of the clinical investigations, device failures and
replacements, contraindications and precautions for use of the device,
and any other appropriate information from the clinical investigations.
Any investigation conducted under an IDE shall be identified as such.
Information on clinical investigations involving human subjects shall
include the following:
(A) For clinical investigations conducted in the United States, a
statement with respect to each investigation that it either was
conducted in compliance with the institutional review board regulations
in part 56 of this chapter, or was not subject to the regulations under
Sec. 56.104 or Sec. 56.105, and that it was conducted in compliance
with the informed consent regulations in part 50 of this chapter; or if
the investigation was not conducted in compliance with those
regulations, a brief statement of the reason for the noncompliance.
Failure or inability to comply with these requirements does not justify
failure to provide information on a relevant clinical investigation.
(B) For clinical investigations conducted in the United States, a
statement that each investigation was conducted in compliance with part
812 of this chapter concerning sponsors of clinical investigations and
clinical investigators, or if the investigation was not conducted in
compliance with those regulations, a brief statement of the reason for
the noncompliance. Failure or inability to comply with these
requirements does not justify failure to provide information on a
relevant clinical investigation.
(C) For clinical investigations conducted outside the United States
that are intended to support the PMA, the requirements under Sec.
812.28 of this chapter apply. If any such investigation was not
conducted in accordance with good clinical practice (GCP) as described
in Sec. 812.28(a), include either a waiver request in accordance with
Sec. 812.28(c) or a brief statement of the reason for not conducting
the investigation in accordance with GCP and a description of steps
taken to ensure that the data and results are credible and accurate and
that the rights, safety, and well-being of subjects have been adequately
protected. Failure or inability to comply with these requirements does
not justify failure to provide information on a relevant clinical
investigation.
(7) For a PMA supported solely by data from one investigation, a
justification showing that data and other information from a single
investigator are sufficient to demonstrate the safety and effectiveness
of the device and to ensure reproducibility of test results.
(8)(i) A bibliography of all published reports not submitted under
paragraph (b)(6) of this section, whether adverse or supportive, known
to or that should reasonably be known to the applicant
[[Page 143]]
and that concern the safety or effectiveness of the device.
(ii) An identification, discussion, and analysis of any other data,
information, or report relevant to an evaluation of the safety and
effectiveness of the device known to or that should reasonably be known
to the applicant from any source, foreign or domestic, including
information derived from investigations other than those proposed in the
application and from commercial marketing experience.
(iii) Copies of such published reports or unpublished information in
the possession of or reasonably obtainable by the applicant if an FDA
advisory committee or FDA requests.
(9) One or more samples of the device and its components, if
requested by FDA. If it is impractical to submit a requested sample of
the device, the applicant shall name the location at which FDA may
examine and test one or more devices.
(10) Copies of all proposed labeling for the device. Such labeling
may include, e.g., instructions for installation and any information,
literature, or advertising that constitutes labeling under section
201(m) of the Federal Food, Drug, and Cosmetic Act.
(11) An environmental assessment under Sec. 25.20(n) prepared in
the applicable format in Sec. 25.40, unless the action qualifies for
exclusion under Sec. 25.30 or Sec. 25.34. If the applicant believes
that the action qualifies for exclusion, the PMA shall under Sec.
25.15(a) and (d) provide information that establishes to FDA's
satisfaction that the action requested is included within the excluded
category and meets the criteria for the applicable exclusion.
(12) A financial certification or disclosure statement or both as
required by part 54 of this chapter.
(13) Information concerning uses in pediatric patients. The
application must include the following information, if readily
available:
(i) A description of any pediatric subpopulations (neonates,
infants, children, adolescents) that suffer from the disease or
condition that the device is intended to treat, diagnose, or cure; and
(ii) The number of affected pediatric patients.
(14) Such other information as FDA may request. If necessary, FDA
will obtain the concurrence of the appropriate FDA advisory committee
before requesting additional information.
(c) Pertinent information in FDA files specifically referred to by
an applicant may be incorporated into a PMA by reference. Information in
a master file or other information submitted to FDA by a person other
than the applicant will not be considered part of a PMA unless such
reference is authorized in a record submitted to FDA by the person who
submitted the information or the master file. If a master file is not
referenced within 5 years after the date that it is submitted to FDA,
FDA will return the master file to the person who submitted it.
(d) If the applicant believes that certain information required
under paragraph (b) of this section to be in a PMA is not applicable to
the device that is the subject of the PMA, and omits any such
information from its PMA, the applicant shall submit a statement that
identifies the omitted information and justifies the omission. The
statement shall be submitted as a separate section in the PMA and
identified in the table of contents. If the justification for the
omission is not accepted by the agency, FDA will so notify the
applicant.
(e) The applicant shall periodically update its pending application
with new safety and effectiveness information learned about the device
from ongoing or completed studies that may reasonably affect an
evaluation of the safety or effectiveness of the device or that may
reasonably affect the statement of contraindications, warnings,
precautions, and adverse reactions in the draft labeling. The update
report shall be consistent with the data reporting provisions of the
protocol. The applicant shall submit any update report in electronic
format and shall include in the report the number assigned by FDA to the
PMA. These updates are considered to be amendments to the PMA. The time
frame for review of a PMA will not be extended due to the submission of
an update report unless the update is a major amendment
[[Page 144]]
under Sec. 814.37(c)(1). The applicant shall submit these reports--
(1) 3 months after the filing date;
(2) Following receipt of an approvable letter; and
(3) At any other time as requested by FDA.
(f) If a color additive subject to section 721 of the Federal Food,
Drug, and Cosmetic Act is used in or on the device and has not
previously been listed for such use, then, in lieu of submitting a color
additive petition under part 71 of this chapter, at the option of the
applicant, the information required to be submitted under part 71 may be
submitted as part of the PMA. When submitted as part of the PMA, the
information shall be submitted in electronic format. A PMA for a device
that contains a color additive that is subject to section 721 of the
Federal Food, Drug, and Cosmetic Act will not be approved until the
color additive is listed for use in or on the device.
(g) Additional information on FDA policies and procedures, as well
as links to PMA guidance documents, is available on the Internet at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/
default.htm.
(h) If you are sending a PMA, PMA amendment, PMA supplement, or
correspondence with respect to a PMA, you must send the submission to
the appropriate address as follows:
(1) For devices regulated by the Center for Devices and Radiological
Health, send it to the current address displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation and
Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
(3) For devices regulated by the Center for Drug Evaluation and
Research, send it to: Central Document Control Room, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266.
[51 FR 26364, July 22, 1986; 51 FR 40415, Nov. 7, 1986, as amended at 51
FR 43344, Dec. 2, 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, July
29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 65 FR
56480, Sept. 19, 2000; 67 FR 9587, Mar. 4, 2002; 71 FR 42048, July 25,
2006; 72 FR 17399, Apr. 9, 2007; 73 FR 34859, June 19, 2008; 74 FR
14478, Mar. 31, 2009; 75 FR 20915, Apr. 22, 2010; 78 FR 18233, Mar. 26,
2013; 79 FR 1740, Jan. 10, 2014; 80 FR 18094, Apr. 3, 2015; 83 FR 7387,
Feb. 21, 2018; 84 FR 68339, Dec. 16, 2019]
Sec. 814.37 PMA amendments and resubmitted PMAs.
(a) An applicant may amend a pending PMA or PMA supplement to revise
existing information or provide additional information.
(b)(1) FDA may request the applicant to amend a PMA or PMA
supplement with any information regarding the device that is necessary
for FDA or the appropriate advisory committee to complete the review of
the PMA or PMA supplement.
(2) FDA may request the applicant to amend a PMA or PMA supplement
with information concerning pediatric uses as required under Sec. Sec.
814.20(b)(13) and 814.39(c)(2).
(c) A PMA amendment submitted to FDA shall include the PMA or PMA
supplement number assigned to the original submission and, if submitted
on the applicant's own initiative, the reason for submitting the
amendment. FDA may extend the time required for its review of the PMA,
or PMA supplement, as follows:
(1) If the applicant on its own initiative or at FDA's request
submits a major PMA amendment (e.g., an amendment that contains
significant new data from a previously unreported study, significant
updated data from a previously reported study, detailed new analyses of
previously submitted data, or significant required information
previously omitted), the review period may be extended up to 180 days.
(2) If an applicant declines to submit a major amendment requested
by FDA, the review period may be extended for the number of days that
elapse between the date of such request and the date that FDA receives
the written response
[[Page 145]]
declining to submit the requested amendment.
(d) An applicant may on its own initiative withdraw a PMA or PMA
supplement. If FDA requests an applicant to submit a PMA amendment and a
written response to FDA's request is not received within 180 days of the
date of the request, FDA will consider the pending PMA or PMA supplement
to be withdrawn voluntarily by the applicant.
(e) An applicant may resubmit a PMA or PMA supplement after
withdrawing it or after it is considered withdrawn under paragraph (d)
of this section, or after FDA has refused to accept it for filing, or
has denied approval of the PMA or PMA supplement. A resubmitted PMA or
PMA supplement shall comply with the requirements of Sec. 814.20 or
Sec. 814.39, respectively, and shall include the PMA number assigned to
the original submission and the applicant's reasons for resubmission of
the PMA or PMA supplement.
[51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014]
Sec. 814.39 PMA supplements.
(a) After FDA's approval of a PMA, an applicant shall submit a PMA
supplement for review and approval by FDA before making a change
affecting the safety or effectiveness of the device for which the
applicant has an approved PMA, unless the change is of a type for which
FDA, under paragraph (e) of this section, has advised that an alternate
submission is permitted or is of a type which, under section
515(d)(6)(A) of the act and paragraph (f) of this section, does not
require a PMA supplement under this paragraph. While the burden for
determining whether a supplement is required is primarily on the PMA
holder, changes for which an applicant shall submit a PMA supplement
include, but are not limited to, the following types of changes if they
affect the safety or effectiveness of the device:
(1) New indications for use of the device.
(2) Labeling changes.
(3) The use of a different facility or establishment to manufacture,
process, or package the device.
(4) Changes in sterilization procedures.
(5) Changes in packaging.
(6) Changes in the performance or design specifications, circuits,
components, ingredients, principle of operation, or physical layout of
the device.
(7) Extension of the expiration date of the device based on data
obtained under a new or revised stability or sterility testing protocol
that has not been approved by FDA. If the protocol has been approved,
the change shall be reported to FDA under paragraph (b) of this section.
(b) An applicant may make a change in a device after FDA's approval
of a PMA for the device without submitting a PMA supplement if the
change does not affect the device's safety or effectiveness and the
change is reported to FDA in postapproval periodic reports required as a
condition to approval of the device, e.g., an editorial change in
labeling which does not affect the safety or effectiveness of the
device.
(c)(1) All procedures and actions that apply to an application under
Sec. 814.20 also apply to PMA supplements except that the information
required in a supplement is limited to that needed to support the
change. A summary under Sec. 814.20(b)(3) is required for only a
supplement submitted for new indications for use of the device,
significant changes in the performance or design specifications,
circuits, components, ingredients, principles of operation, or physical
layout of the device, or when otherwise required by FDA. The applicant
shall submit a PMA supplement in electronic format and shall include
information relevant to the proposed changes in the device. A PMA
supplement shall include a separate section that identifies each change
for which approval is being requested and explains the reason for each
such change. The applicant shall submit additional information, if
requested by FDA, in electronic format. The time frames for review of,
and FDA action on, a PMA supplement are the same as those provided in
Sec. 814.40 for a PMA.
(2) The supplement must include the following information:
(i) Information concerning pediatric uses as required under Sec.
814.20(b)(13).
[[Page 146]]
(ii) If information concerning the device that is the subject of the
supplement was previously submitted under Sec. 814.20(b)(13) or under
this section in a previous supplement, that information may be included
by referencing a previous application or submission that contains the
information. However, if additional information required under Sec.
814.20(b)(13) has become readily available to the applicant since the
previous submission, the applicant must submit that information as part
of the supplement.
(d)(1) After FDA approves a PMA, any change described in paragraph
(d)(2) of this section to reflect newly acquired information that
enhances the safety of the device or the safety in the use of the device
may be placed into effect by the applicant prior to the receipt under
Sec. 814.17 of a written FDA order approving the PMA supplement
provided that:
(i) The PMA supplement and its mailing cover are plainly marked
``Special PMA Supplement--Changes Being Effected'';
(ii) The PMA supplement provides a full explanation of the basis for
the changes;
(iii) The applicant has received acknowledgement from FDA of receipt
of the supplement; and
(iv) The PMA supplement specifically identifies the date that such
changes are being effected.
(2) The following changes are permitted by paragraph (d)(1) of this
section:
(i) Labeling changes that add or strengthen a contraindication,
warning, precaution, or information about an adverse reaction for which
there is reasonable evidence of a causal association.
(ii) Labeling changes that add or strengthen an instruction that is
intended to enhance the safe use of the device.
(iii) Labeling changes that delete misleading, false, or unsupported
indications.
(iv) Changes in quality controls or manufacturing process that add a
new specification or test method, or otherwise provide additional
assurance of purity, identity, strength, or reliability of the device.
(e)(1) FDA will identify a change to a device for which an applicant
has an approved PMA and for which a PMA supplement under paragraph (a)
is not required. FDA will identify such a change in an advisory opinion
under Sec. 10.85, if the change applies to a generic type of device, or
in correspondence to the applicant, if the change applies only to the
applicant's device. FDA will require that a change for which a PMA
supplement under paragraph (a) is not required be reported to FDA in:
(i) A periodic report under Sec. 814.84 or
(ii) A 30-day PMA supplement under this paragraph.
(2) FDA will identify, in the advisory opinion or correspondence,
the type of information that is to be included in the report or 30-day
PMA supplement. If the change is required to be reported to FDA in a
periodic report, the change may be made before it is reported to FDA. If
the change is required to be reported in a 30-day PMA supplement, the
change may be made 30 days after FDA files the 30-day PMA supplement
unless FDA requires the PMA holder to provide additional information,
informs the PMA holder that the supplement is not approvable, or
disapproves the supplement. The 30-day PMA supplement shall follow the
instructions in the correspondence or advisory opinion. Any 30-day PMA
supplement that does not meet the requirements of the correspondence or
advisory opinion will not be filed and, therefore, will not be deemed
approved 30 days after receipt.
(f) Under section 515(d) of the act, modifications to manufacturing
procedures or methods of manufacture that affect the safety and
effectiveness of a device subject to an approved PMA do not require
submission of a PMA supplement under paragraph (a) of this section and
are eligible to be the subject of a 30-day notice. A 30-day notice shall
describe in detail the change, summarize the data or information
supporting the change, and state that the change has been made in
accordance with the requirements of part 820 of this chapter. The
manufacturer may distribute the device 30 days after the date on which
FDA receives the 30-day
[[Page 147]]
notice, unless FDA notifies the applicant within 30 days from receipt of
the notice that the notice is not adequate. If the notice is not
adequate, FDA shall inform the applicant in writing that a 135-day PMA
supplement is needed and shall describe what further information or
action is required for acceptance of such change. The number of days
under review as a 30-day notice shall be deducted from the 135-day PMA
supplement review period if the notice meets appropriate content
requirements for a PMA supplement.
(g) The submission and grant of a written request for an exception
or alternative under Sec. 801.128 or Sec. 809.11 of this chapter
satisfies the requirement in paragraph (a) of this section.
[51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 63
FR 54044, Oct. 8, 1998; 67 FR 9587, Mar. 4, 2002; 69 FR 11313, Mar. 10,
2004; 72 FR 73602, Dec. 28, 2007; 73 FR 49610, Aug. 22, 2008; 79 FR
1740, Jan. 10, 2014; 84 FR 68340, Dec. 16, 2019]