[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48671-48676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17150]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 058
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 058'' (Recognition List Number: 058), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Either electronic or written comments can be submitted on the
notice at any time. These modifications to the list of recognized
standards are applicable August 10, 2022.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your
[[Page 48672]]
comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 058.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 058.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
An electronic copy of Recognition List Number: 058 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA-recognized consensus standards, including Recognition List Number:
058 modifications and other standards-related information. Submit
written requests for a single hard copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 058'' to Jianchao Zeng, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. Send one self-
addressed adhesive label to assist that office in processing your
request, or Fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
of the FD&C Act allows FDA to recognize consensus standards developed
by international and national organizations for use in satisfying
portions of device premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains on its
website HTML and PDF versions of the list of FDA Recognized Consensus
Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
Additional information on the Agency's Standards and Conformity
Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 058
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 058'' to identify the current
modifications.
In table 1, FDA describes the following modifications: (1) the
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 058.
[[Page 48673]]
Table 1--Modifications to the List of Recognized Standards
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Replacement
Old recognition Title of standard \1\ Change
recognition No. No.
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A. Anesthesiology
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No new entries at this time.
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B. Biocompatibility
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2-174.......... 2-296 ISO 10993-10 Fourth Withdrawn and
edition 2021-11 replaced with
Biological newer version.
evaluation of
medical devices--
Part 10: Tests for
skin sensitization.
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C. Cardiovascular
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3-116.......... 3-181 ISO 25539-2 Third Withdraw and
edition 2020-09 replaced with
Cardiovascular newer version.
implants--Endovascul
ar devices--Part 2:
Vascular stents.
3-137.......... 3-182 ASTM F3036-21 Withdrawn and
Standard Guide for replaced with
Testing Absorbable newer version.
Stents.
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D. Dental/Ear, Nose, and Throat (ENT)
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4-236.......... 4-293 ANSI/ADA Standard No. Withdrawn and
119-2021 Manual replaced with
Toothbrushes. newer version.
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E. General I (Quality Systems/Risk Management) (QS/RM)
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No new entries at this time.
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F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
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19-4........... 19-46 ANSI/AAMI ES60601- Withdrawn and
1:2005/(R)2012 and replaced with
A1:2012, C1:2009/ newer version.
(R)2012 and A2:2010/
(R)2012
(Consolidated Text)
Medical electrical
equipment--Part 1:
General requirements
for basic safety and
essential
performance (IEC
60601-1:2005, MOD)
[Including Amendment
2 (2021)].
19-16.......... 19-47 ANSI/AAMI HA60601-1- Withdrawn and
11:2015 Medical replaced with
Electrical newer version.
Equipment--Part 1-
11: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for
medical electrical
equipment and
medical electrical
equipment and
medical electrical
systems used in the
home healthcare
environment (IEC
60601-1-11:2015 MOD)
[Including AMD
1:2021].
19-30.......... 19-45 AIM Standard 7351731 Withdrawn and
Rev. 3.00 2021-06-04 replaced with
Medical Electrical newer version.
Equipment and System
Electromagnetic
Immunity Test for
Exposure to Radio
Frequency
Identification
Readers--An AIM
Standard.
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G. General Hospital/General Plastic Surgery (GH/GPS)
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6-174.......... 6-475 ISO 11608-4:2022 Withdrawn and
Needle-based replaced with
injection systems newer version.
for medical use--
Requirements and
test methods--Part
4: Needle-based
injection systems
containing
electronics.
6-275.......... 6-476 ISO 11608-2:2022 Withdrawn and
Needle-based replaced with
injection systems newer version.
for medical use--
Requirements and
test methods--Part
2: Double-ended pen
needles.
6-294.......... 6-477 ISO 11608-3:2022 Withdrawn and
Needle-based replaced with
injection systems newer version.
for medical use--
Requirements and
test methods--Part
3: Containers and
integrated fluid
path.
6-341.......... 6-478 ISO 11608-1:2022 Withdrawn and
Needle-based replaced with
injection systems newer version.
for medical use--
Requirements and
test methods--Part
1: Needle-based
injection systems.
6-377.......... 6-479 ISO 11608-5:2022 Withdrawn and
Needle-based replaced with
injection systems newer version.
for medical use--
Requirements and
test methods--Part
5: Automated
functions.
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H. In Vitro Diagnostics (IVD)
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7-303.......... .............. CLSI M60 2nd Edition Extent of
Performance recognition.
Standards for
Antifungal
Susceptibility
Testing of Yeast.
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I. Materials
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8-336.......... 8-583 ASTM F562-22 Standard Withdrawn and
Specification for replaced with
Wrought 35Cobalt- newer version.
35Nickel-20Chromium-
10Molybdenum Alloy
for Surgical Implant
Applications (UNS
R30035).
8-347.......... 8-584 ASTM F2146-22 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Titanium-
3Aluminum-
2.5Vanadium Alloy
Seamless Tubing for
Surgical Implant
Applications (UNS
R56320).
[[Page 48674]]
8-354.......... 8-585 ASTM F1377-21 Withdrawn and
Standard replaced with
Specification for newer version.
Cobalt-28Chromium-
6Molybdenum Powder
for Medical Devices
(UNS R30075, UNS
R31537, and UNS
R31538).
8-362.......... 8-586 ASTM F2989-21 Withdrawn and
Standard replaced with
Specification for newer version.
Metal Injection
Molded Unalloyed
Titanium Components
for Surgical Implant
Applications.
8-447.......... 8-587 ISO 5832-3 Fifth Withdrawn and
Edition 2021-11 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 3:
Wrought titanium 6-
aluminium 4-vanadium
alloy.
8-469.......... 8-588 ASTM F560-22 Standard Withdrawn and
Specification for replaced with
Unalloyed Tantalum newer version.
for Surgical Implant
Applications (UNS
R05200, UNS R05400).
8-471.......... 8-589 ASTM F1925-22 Withdrawn and
Standard replaced with
Specification for newer version.
Semi-Crystalline
Poly(lactide)
Polymer and
Copolymer Resins for
Surgical Implants.
8-525.......... 8-590 ISO/TS 17137 Third Withdrawn and
Edition 2021-09 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Cardiovascu
lar absorbable
implants.
------------------------------------------------------------------------
J. Nanotechnology
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No new entries at this time.
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K. Neurology
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No new entries at this time.
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L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
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M. Ophthalmic
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10-110......... 10-131 ISO 15798 Fourth Withdrawn and
edition 2022-01 replaced with
Ophthalmic implants-- newer version.
Ophthalmic
viscosurgical
devices.
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N. Orthopedic
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No new entries at this time.
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O. Physical Medicine
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16-166......... .............. ISO 7176-21 Second Extent of
edition 2009-04-01 recognition
Wheelchairs--Part
21: Requirements and
test methods for
electromagnetic
compatibility of
electrically powered
wheelchairs and
scooters, and
battery chargers.
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P. Radiology
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12-277......... 12-343 IEC 62127-1 Edition Withdrawn and
2.0 2022-03 replaced with
Ultrasonics--Hydroph newer version.
ones--Part 1:
Measurement and
characterization of
medical ultrasonic
fields.
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Q. Software/Informatics
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No new entries at this time.
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R. Sterility
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14-478......... 14-572 ANSI/AAMI ST91:2021 Withdrawn and
Flexible and semi- replaced with
rigid endoscope newer version.
processing in health
care facilities.
14-482......... 14-573 ASTM F88/F88M-21 Withdrawn and
Standard Test Method replaced with
for Seal Strength of newer version.
Flexible Barrier
Materials.
14-496......... 14-574 ASTM F1608-21 Withdrawn and
Standard Test Method replaced with
for Microbial newer version.
Ranking of Porous
Packaging Materials
(Exposure Chamber
Method).
14-497......... 14-575 ASTM F1980-21 Withdrawn and
Standard Guide for replaced with
Accelerated Aging of newer version.
Sterile Barrier
Systems and Medical
Devices.
14-499......... 14-576 ASTM D4169-22 Withdrawn and
Standard Practice replaced with
for Performance newer version.
Testing of Shipping
Containers and
Systems.
14-514......... 14-577 ISO 11737-1 Third Withdrawn and
edition 2018-01 replaced with
[Including: AMD1 newer version.
(2021)]
Sterilization of
health care
products--Microbiolo
gical methods--Part
1: Determination of
a population of
microorganisms on
product [Including:
Amendment 1 (2021)].
14-515......... 14-578 ISO 17664-1 First Extent of
edition 2021-07 Recognition.
Processing of health Withdrawn and
care products-- replaced with
Information to be newer version.
provided by the
medical device
manufacturer for the
processing of
medical devices--
Part 1: Critical and
semi-critical
medical devices.
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[[Page 48675]]
S. Tissue Engineering
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No new entries at this time.
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\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 058. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
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A. Anesthesiology
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1-152................ Medical electrical ISO 80601-2-87 First
equipment--Part 2-87: edition 2021-04.
Particular requirements
for basic safety and
essential performance of
high-frequency
ventilators.
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B. Biocompatibility
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No new entries at this time.
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C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
15-135............... Medical devices-- ISO 20417 First
Information to be edition 2021-04
supplied by the Corrected version
manufacturer. 2021-12.
------------------------------------------------------------------------
F. General II (ES/EMC)
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No new entries at this time.
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G. GH/GPS
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6-480................ Needle-based injection ISO 11608-6:2022.
systems for medical use--
requirements and test
methods--Part 6: On-body
delivery systems.
6-481................ General requirements for ANSI/AAMI CN27:2021.
Luer activated valves
(LAVs) incorporated into
medical devices for
intravascular
applications.
6-482................ Fluid delivery performance AAMI TIR101:2021.
testing for infusion
pumps.
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H. IVD
------------------------------------------------------------------------
7-312................ Analysis and Presentation CLSI M39 5th Edition.
of Cumulative
Antimicrobial
Susceptibility Test Data.
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I. Materials
------------------------------------------------------------------------
8-591................ Standard Specification for ASTM F2229-21.
Wrought, Nitrogen
Strengthened 23Manganese-
21Chromium-1Molybdenum
Low-Nickel Stainless
Steel Alloy Bar and Wire
for Surgical Implants
(UNS S29108).
8-592................ Standard Specification for ASTM F3384-21.
Polydioxanone Polymer
Resins for Surgical
Implants.
8-593................ Implants for surgery-- ISO 13779-6 First
Hydroxyapatite--Part 6: edition 2015-01-15
Powders. Corrected Version
2016-09-15.
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[[Page 48676]]
J. Nanotechnology
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No new entries at this time.
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K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-139................ Colorimetry--Part 5: CIE ISO/CIE 11664-5:2016.
1976 L*u*v* colour space
and u',v' uniform
chromaticity scale
diagram.
------------------------------------------------------------------------
M. Ophthalmic
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No new entries at this time.
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N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-344............... Medical electrical IEC 62563-2 Edition
equipment--Medical image 1.0 2021-11.
display systems--Part 2:
Acceptance and constancy
tests for medical image
displays.
12-345............... Evaluation and routine IEC 61223-3-7 Edition
testing in medical 1.0 2021-12.
imaging departments--Part
3-7: Acceptance and
constancy tests--Imaging
performance of X-ray
equipment for dental cone
beam computed tomography.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-579............... Processing of health care ISO 17664-2 First
products--Information to edition 2021-02.
be provided by the
medical device
manufacturer for the
processing of medical
devices--Part 2: Non-
critical medical devices.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17150 Filed 8-9-22; 8:45 am]
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