[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22678-22686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08992]
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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: 055
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: 055'' (Recognition List Number: 055), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable April 29, 2021.
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: http://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 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
[[Page 22679]]
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: 055.'' 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: 055.
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: 055 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:
055 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: 055'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. 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: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287,
[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
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 hypertext markup language (HTML) and portable document format
(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: 055
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: 055'' 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: 055.
[[Page 22680]]
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Old Replacement
recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-79........... 1-147 ISO 26825 Second Withdrawn and
edition 2020-10 replaced with
Anaesthetic and newer version.
respiratory
equipment--User-
applied labels for
syringes containing
drugs used during
anaesthesia--Colours
, design and
performance.
1-102.......... 1-148 ISO 80601-2-69 Second Withdrawn and
edition 2020-11 replaced with
Medical electrical newer version.
equipment--Part 2-
69: Particular
requirements for the
basic safety and
essential
performance of
oxygen concentrator
equipment.
1-123.......... 1-149 ISO 7376 Third Withdrawn and
edition 2020-08 replaced with
Anaesthetic and newer version.
respiratory
equipment--Laryngosc
opes for tracheal
intubation.
1-125.......... 1-150 ISO 8836 Fifth Withdrawn and
edition 2019-12 replaced with
Suction catheters newer version.
for use in the
respiratory tract.
1-146.......... .............. ISO 80601-2-12 Second Transition
edition 2020-02 period
Medical electrical extended.
equipment--Part 2-
12: Particular
requirements for
basic safety and
essential
performance of
critical care
ventilators.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-119.......... 2-277 ASTM F813-20 Standard Withdrawn and
Practice for Direct replaced with
Contact Cell Culture newer version.
Evaluation of
Materials for
Medical Devices.
2-122.......... 2-278 ASTM F719-20 [egr]1 Withdrawn and
Standard Practice replaced with
for Testing newer version.
Materials in Rabbits
for Primary Skin
Irritation.
2-124.......... 2-279 ASTM F750-20 Standard Withdrawn and
Practice for replaced with
Evaluating Acute newer version.
Systemic Toxicity of
Material Extracts by
Systemic Injection
in the Mouse.
2-133.......... 2-280 ASTM F1408-20a Withdrawn and
Standard Practice replaced with
for Subcutaneous newer version.
Screening Test for
Implant Materials.
2-167.......... 2-281 ISO 10993-19 Second Withdrawn and
edition 2020-03 replaced with
Biological newer version.
evaluation of
medical devices--
Part 19: Physico-
chemical,
morphological and
topographical
characterization of
materials.
2-205.......... 2-282 ISO 14155 Third Withdrawn and
edition 2020-07 replaced with
Clinical newer version.
investigation of
medical devices for
human subjects--Good
clinical practice.
2-214.......... 2-283 ASTM F619-20 Standard Withdrawn and
Practice for replaced with
Extraction of newer version.
Materials Used in
Medical Devices.
2-269.......... 2-284 USP 43-NF38:2020 <87> Withdrawn and
Biological replaced with
Reactivity Test, In newer version.
Vitro--Direct
Contact Test.
2-270.......... 2-285 USP 43-NF38:2020 <87> Withdrawn and
Biological replaced with
Reactivity Test, In newer version.
Vitro--Elution Test.
2-271.......... 2-286 USP 43-NF38:2020 <88> Withdrawn and
Biological replaced with
Reactivity Tests, In newer version.
Vivo.
2-272.......... 2-287 USP 43-NF38:2020 Withdrawn and
<151> Pyrogen Test replaced with
(USP Rabbit Test). newer version.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-92........... 4-264 ANSI/ADA Standard No. Withdrawn and
88--2019 Dental replaced with
Brazing Alloys. newer version.
4-243.......... .............. ISO 10271 First Withdrawn.
edition 2001-06
Dental metallic
materials--Corrosion
test methods.
4-245.......... 4-265 ISO 10271 Third Withdrawn and
edition 2020-08 replaced with
Dentistry--Corrosion newer version.
test methods for
metallic materials.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-76........... 5-131 IEC 60601-1-8 Edition Withdrawn and
2.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-8:
General requirements
for basic safety and
essential
performance--Collate
ral standard:
General
requirements, tests
and guidance for
alarm systems in
medical electrical
equipment and
medical electrical
systems.
5-89........... 5-132 IEC 60601-1-6 Edition Withdrawn and
3.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-6:
General requirements
for basic safety and
essential
performance--Collate
ral standard:
Usability.
5-115.......... 5-133 ISO 80369-7 Second Withdrawn and
edition 2021 Small- replaced with
bore connectors for newer version.
liquids and gases in
healthcare
applications--Part
7: Connectors for
intravascular or
hypodermic
applications.
------------------------------------------------------------------------
[[Page 22681]]
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-8........... 19-36 IEC 60601-1-2 Edition Withdrawn and
4.1 2020-09 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-2:
General requirements
for basic safety and
essential
performance--Collate
ral Standard:
Electromagnetic
disturbances--Requir
ements and tests.
19-9........... 19-37 IEC 60601-1-10 Withdrawn and
Edition 1.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
10: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for the
development of
physiologic closed-
loop controllers.
19-14.......... 19-38 IEC 60601-1-11 Withdrawn and
Edition 2.1 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
11: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for
medical electrical
equipment and
medical electrical
systems used in the
home healthcare
environment.
19-15.......... 19-39 IEC 60601-1-12 Withdrawn and
Edition 1.1 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
12: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for
medical electrical
equipment and
medical electrical
systems intended for
use in the emergency
medical services
environment.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-11........... .............. ISO 594-1 First Withdrawn. See 5-
edition 1986-06-15 133.
Conical fittings
with a 6% (Luer)
taper for syringes,
needles and certain
other medical
equipment--Part 1:
General requirements.
6-129.......... .............. ISO 594-2 Second Withdrawn. See 5-
edition 1998-09-01 133.
Conical fittings
with a 6% (Luer)
taper for syringes,
needles and certain
other medical
equipment--Part 2:
Lock fittings.
6-180.......... 6-448 ASTM F2407-20 Withdrawn and
Standard replaced with
Specification for newer version.
Surgical Gowns
Intended for Use in
Healthcare
Facilities.
6-339.......... 6-449 ASTM F1169-19 Withdrawn and
Standard Consumer replaced with
Safety Specification newer version.
for Full-Size Baby
Cribs.
6-340.......... .............. ASTM F2710-13 Withdrawn.
Standard Consumer
Safety Performance
Specification for
Commercial Cribs.
6-387.......... 6-450 IEC 60601-2-50 Ed. Withdrawn and
3.0 2020-09 Medical replaced with
electrical newer version.
equipment--Part 2-
50: Particular
requirements for the
basic safety and
essential
performance of
infant phototherapy
equipment.
6-428.......... 6-451 USP 43-NF38:2020 Withdrawn and
Sodium Chloride replaced with
Irrigation. newer version.
6-429.......... 6-452 USP 43-NF38:2020 Withdrawn and
Sodium Chloride replaced with
Injection. newer version.
6-430.......... 6-453 USP 43-NF38:2020 Withdrawn and
Nonabsorbable replaced with
Surgical Suture. newer version.
6-431.......... 6-454 USP 43-NF38:2020 Withdrawn and
<881> Tensile replaced with
Strength. newer version.
6-432.......... 6-455 USP 43-NF38:2020 Withdrawn and
<861> Sutures-- replaced with
Diameter. newer version.
6-433.......... 6-456 USP 43-NF38:2020 Withdrawn and
<871> Sutures-- replaced with
Needle Attachment. newer version.
6-434.......... 6-457 USP 43-NF38:2020 Withdrawn and
Sterile Water for replaced with
Irrigation. newer version.
6-435.......... 6-458 USP 43-NF38:2020 Withdrawn and
Heparin Lock Flush replaced with
Solution. newer version.
6-436.......... 6-459 USP 43-NF38:2020 Withdrawn and
Absorbable Surgical replaced with
Suture. newer version.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-101.......... .............. CLSI H51-A Assays of Withdrawn.
von Willebrand
Factor Antigen and
Ristocetin Cofactor
Activity; Approved
Guideline.
7-112.......... 7-299 CLSI POCT14 2nd Withdrawn and
Edition Point-of- replaced with
Care Coagulation newer version.
Testing and
Anticoagulation
Monitoring.
7-131.......... .............. CLSI I/LA18-A2 Withdrawn.
(Replaces I/LA18-A)
Specifications for
Immunological
Testing for
Infectious Diseases;
Approved Guideline--
Second Edition.
7-135.......... .............. CLSI H44-A2 (Replaces Withdrawn.
H44-A) Methods for
Reticulocyte
Counting (Automated
Blood Cell Counters,
Flow Cytometry, and
Supravital Dyes);
Approved Guideline--
Second Edition.
7-142.......... .............. CLSI GP43-A4 Withdrawn.
(Formerly H11-A4)
Procedures for the
Collection of
Arterial Blood
Specimens; Approved
Standard--Fourth
Edition.
[[Page 22682]]
7-146.......... .............. CLSI M06-A2 Protocols Withdrawn.
for Evaluating
Dehydrated Mueller-
Hinton Agar;
Approved Standard--
Second Edition.
7-164.......... .............. CLSI GP28-A (Replaces Withdrawn.
GP28-P) Microwave
Device Use in the
Histology
Laboratory; Approved
Guideline.
7-173.......... .............. CLSI C44-A (Replaces Withdrawn.
C44-P) Harmonization
of Glycohemoglobin
Measurements;
Approved Guideline.
7-191.......... 7-300 CLSI MM13 2nd Edition Withdrawn and
Collection, replaced with
Transport, newer version.
Preparation, and
Storage of Specimens
for Molecular
Methods.
7-203.......... 7-301 CLSI GP42 7th Edition Withdrawn and
Collection of replaced with
Capillary Blood newer version.
Specimens.
7-211.......... 7-302 CLSI C34 4th Edition Withdrawn and
Sweat Testing: replaced with
Specimen Collection newer version.
and Quantitative
Chloride Analysis.
7-217.......... 7-303 CLSI M60 2nd Edition Withdrawn and
Performance replaced with
Standards for newer version.
Antifungal
Susceptibility
Testing of Yeast.
7-261.......... 7-304 CLSI M23 5th Edition Withdrawn and
Development of In replaced with
Vitro Susceptibility newer version.
Testing Criteria and
Quality Control
Parameters.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-217.......... 8-537 ASTM F620-20 Standard Withdrawn and
Specification for replaced with
Titanium Alloy newer version.
Forgings for
Surgical Implants in
the Alpha Plus Beta
Condition.
8-223.......... 8-538 ASTM F2759-19 Withdrawn and
Standard Guide for replaced with
Assessment of the newer version.
Ultra-High Molecular
Weight Polyethylene
(UHMWPE) Used in
Orthopedic and
Spinal Devices.
8-338.......... 8-539 ASTM F139-19 Standard Withdrawn and
Specification for replaced with
Wrought 18Chromium- newer version.
14Nickel-
2.5Molybdenum
Stainless Steel
Sheet and Strip for
Surgical Implants
(UNS S31673).
8-339.......... 8-540 ASTM F1091-20 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
20Chromium-
15Tungsten-10Nickel
Alloy Surgical
Fixation Wire (UNS
R30605).
8-342.......... 8-541 ASTM F1537-20 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
28Chromium-
6Molybdenum Alloys
for Surgical
Implants (UNS
R31537, UNS R31538,
and UNS R31539).
8-348.......... 8-542 ASTM F138-19 Standard Withdrawn and
Specification for replaced with
Wrought 18Chromium- newer version.
14Nickel-
2.5Molybdenum
Stainless Steel Bar
and Wire for
Surgical Implants
(UNS S31673).
8-361.......... 8-543 ASTM F755-19 Standard Withdrawn and
Specification for replaced with
Selection of Porous newer version.
Polyethylene for Use
in Surgical Implants.
8-395.......... 8-544 ASTM F961-20 Standard Withdrawn and
Specification for replaced with
35Cobalt-35Nickel- newer version.
20Chromium-
10Molybdenum Alloy
Forgings for
Surgical Implants
(UNS R30035).
8-416.......... 8-545 ASTM F2977-20 Withdrawn and
Standard Test Method replaced with
for Small Punch newer version.
Testing of Polymeric
Biomaterials Used in
Surgical Implants.
8-417.......... 8-546 ASTM F3044-20 Withdrawn and
Standard Test Method replaced with
for Evaluating the newer version.
Potential for
Galvanic Corrosion
for Medical Implants.
8-421.......... 8-547 ASTM F629-20 Standard Withdrawn and
Practice for replaced with
Radiography of Cast newer version.
Metallic Surgical
Implants.
8-438.......... 8-548 ISO/ASTM 52915 Third Withdrawn and
edition 2020-03 replaced with
Specification for newer version.
additive
manufacturing file
format (AMF) Version
1.2.
8-530.......... 8-549 ASTM F3208-20 Withdrawn and
Standard Guide for replaced with
Selecting Test Soils newer version.
for Validation of
Cleaning Methods for
Reusable Medical
Devices.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-40........... 9-130 ISO 8600-6: Second Withdrawn and
Edition 2020-09 replaced with
Endoscopes--Medical newer version.
endoscopes and
endotherapy devices--
Part 6: Vocabulary.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-48.......... 10-119 ISO 11979-5 Third Withdrawn and
edition 2020-09 replaced with
Ophthalmic implants-- newer version.
Intraocular Lenses--
Part 5:
Biocompatibility.
[[Page 22683]]
10-63.......... 10-120 ISO/TR 22979 Second Withdrawn and
Edition 2017-05 replaced with
Ophthalmic implants-- newer version.
Intraocular Lenses--
Guidance on
assessment of the
need for clinical
investigation of
intraocular lens
design modifications.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-191......... 11-370 ISO 14879-1 Second Withdrawn and
edition 2020-07 replaced with
Implants for newer version.
surgery--Total knee-
joint prostheses--
Part 1:
Determination of
endurance properties
of knee tibial trays.
11-267......... 11-371 ASTM F2009-20 Withdrawn and
Standard Test Method replaced with
for Determining the newer version.
Axial Disassembly
Force of Taper
Connections of
Modular Prostheses.
11-279......... 11-372 ASTM F2996-20 Withdrawn and
Standard Practice replaced with
for Finite Element newer version.
Analysis (FEA) of
Non-Modular Metallic
Orthopaedic Hip
Femoral Stems.
11-282......... 11-373 ASTM F1223-20 Withdrawn and
Standard Test Method replaced with
for Determination of newer version.
Total Knee
Replacement
Constraint.
11-313......... 11-374 ISO 7207-2 Second Withdrawn and
edition 2011-07-01 replaced with
Implants for newer version.
surgery--Components
for partial and
total knee joint
prostheses--Part 2:
Articulating
surfaces made of
metal, ceramic and
plastics materials
[Including AMENDMENT
1 (2016) and
AMENDMENT 2 (2020)].
11-330......... .............. ASTM F2028-17 Extent of
Standard Test recognition.
Methods for Dynamic
Evaluation of
Glenoid Loosening or
Disassociation.
11-332......... 11-375 ASTM F2193-20 Withdrawn and
Standard replaced with
Specifications and newer version.
Test Methods for
Components Used in
the Surgical
Fixation of the
Spinal Skeletal
System.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-314......... 14-550 ANSI/AAMI ST67:2019 Withdrawn and
Sterilization of replaced with
health care newer version.
products--Requiremen
ts and guidance for
selecting a
sterility assurance
level (SAL) for
products labeled
``sterile''.
14-361......... 14-551 ISO 14160 Third Withdrawn and
edition 2020-09 replaced with
Sterilization of newer version.
health care
products--Liquid
chemical sterilizing
agents for single-
use medical devices
utilizing animal
tissues and their
derivatives--Require
ments for
characterization,
development,
validation and
routine control of a
sterilization
process for medical
devices.
14-411......... 14-552 ISO/ASTM 51818 Fourth Withdrawn and
edition 2020-06 replaced with
Practice for newer version.
dosimetry in an
electron beam
facility for
radiation processing
at energies between
80 and 300 keV.
14-498......... 14-553 ASTM F2097-20 Withdrawn and
Standard Guide for replaced with
Design and newer version.
Evaluation of
Primary Flexible
Packaging for
Medical Products.
14-519......... 14-554 ASTM F17-20 Standard Withdrawn and
Terminology Relating replaced with
to Primary Barrier newer version.
Packaging.
14-534......... 14-555 USP 43-NF38:2020 Withdrawn and
<161> Medical replaced with
Devices-Bacterial newer version.
Endotoxin and
Pyrogen Tests.
14-535......... 14-556 USP 43-NF38:2020 <62> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Tests for Specified
Microorganisms.
14-536......... 14-557 USP 43-NF38:2020 <55> Withdrawn and
Biological replaced with
Indicators--Resistan newer version.
ce Performance Tests.
14-537......... 14-558 USP 43-NF38:2020 Withdrawn and
<1229.5> Biological replaced with
Indicators for newer version.
Sterilization.
14-546......... 14-559 USP 43-NF38:2020 <61> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Microbial
Enumeration Tests.
14-547......... 14-560 USP 43-NF38:2020 <71> Withdrawn and
Sterility Tests. replaced with
newer version.
14-548......... 14-561 USP 43-NF38:2020 <85> Withdrawn and
Bacterial Endotoxins replaced with
Test. newer version.
------------------------------------------------------------------------
[[Page 22684]]
S. Tissue Engineering
------------------------------------------------------------------------
15-35.......... .............. ASTM F2900-11 Withdrawn.
Standard Guide for
Characterization of
Hydrogels used in
Regenerative
Medicine.
15-36.......... .............. ASTM F2383-11 Withdrawn.
Standard Guide for
Assessment of
Adventitious Agents
in Tissue Engineered
Medical Products
(TEMPs).
15-38.......... .............. ASTM F2883-11 Withdrawn.
Standard Guide for
Characterization of
Ceramic and Mineral
Based Scaffolds used
for Tissue-
Engineered Medical
Products (TEMPs) and
as Device for
Surgical Implant
Applications.
15-45.......... 15-64 ISO 22442-1 Third Withdrawn and
edition 2020-09 replaced with
Medical devices newer version.
utilizing animal
tissues and their
derivatives--Part 1:
Application of risk
management.
15-46.......... 15-65 ISO 22442-2 Third Withdrawn and
edition 2020-09 replaced with
Medical devices newer version.
utilizing animal
tissues and their
derivatives--Part 2:
Controls on
sourcing, collection
and handling.
------------------------------------------------------------------------
\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: 055. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-288..................... Biological evaluation of medical devices--Part 15: ISO 10993-15 Second edition
Identification and quantification of degradation 2019-11.
products from metals and alloys.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-169..................... Medical electrical equipment--Part 2-4: Particular IEC Edition 3.1 2018-02
requirements for the basic safety and essential CONSOLIDATED VERSION.
performance of cardiac defibrillators.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-266..................... Dentistry--Orthodontic anchor screws............... ISO 19023 First edition 2018-
02.
4-267..................... Dentistry--Elastomeric auxiliaries for use in ISO 21606 First edition 2007-
orthodontics. 06.
4-268..................... Dentistry--Wires for use in orthodontics [Including ISO 15841 Second edition 2014-
AMENDMENT 1 (2020)]. 08.
4-269..................... Dentistry--Coupling dimensions for handpiece ISO 3964 Third edition 11-2016.
connectors [Including AMENDMENT 1 (2018)].
4-270..................... CAD/CAM Abutments in Dentistry..................... ADA Technical Report No. 146-
2018.
4-271..................... Dental Cartridge Syringes.......................... ANSI/ADA Standard No. 34-2013.
4-272..................... Root Canal Barbed Broaches and Rasps............... ANSI/ADA Standard No. 63-2013.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-305..................... In vitro diagnostic medical devices--Requirements ISO 17511 Second edition 2020-
for establishing metrological traceability of 04.
values assigned to calibrators, trueness control
materials and human samples..
----------------------------------------------------------------------------------------------------------------
[[Page 22685]]
I. Materials
----------------------------------------------------------------------------------------------------------------
8-550..................... Standard Specification for Wrought Seamless ASTM F2181-20.
Stainless Steel Tubing for Surgical Implants.
8-551..................... Standard Practice for Digital Radiography of Cast ASTM F2895-20.
Metallic Implants.
8-552..................... Guide for Additive manufacturing--Installation/ ASTM F3434-20.
Operation and Performance Qualification (IQ/OQ/PQ)
of Laser-Beam Powder Bed Fusion Equipment for
Production Manufacturing New publication.
8-553..................... Additive manufacturing--Material extrusion-based ISO/ASTM 52903-1 First edition
additive manufacturing of plastic materials--Part 2020-04.
1: Feedstock materials.
8-554..................... Additive manufacturing--Design--Functionally graded ISO/ASTM TR 52912 First edition
additive manufacturing. 2020-09.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-17..................... Nanotechnologies--Measurements of particle size and ISO 21363 First edition 2020-
shape distributions by transmission electron 06.
microscopy.
18-18..................... Standard Test Method for Measuring the Size of ASTM E3247-20.
Nanoparticles in Aqueous Media Using Dynamic Light
Scattering.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-17..................... Standard Specification for Neurosurgical Head ASTM F3395/F3395M-19.
Holder Devices.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-121.................... Ophthalmic implants--Ocular endotamponades......... ISO 16672 Third edition 2020-
06.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-230.................... American National Standard for Wheelchairs--Volume ANSI/RESNA WC-2:2019 Section
2: Additional Requirements for Wheelchairs 25.
(including Scooters) with Electrical Systems
Section 25: Batteries and Chargers for Powered
Wheelchairs.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-116.................... Common Vulnerability Scoring System version 3.0.... FIRST CVSS v3.0.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
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
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
[[Page 22686]]
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: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08992 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P