[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50870-50876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16418]
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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: 059
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: 059'' (Recognition List Number: 059), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
[[Page 50871]]
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable August 2, 2023.
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 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: 059.'' 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: 059.
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: 059 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:
059 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: 059'' 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.
[[Page 50872]]
II. Modifications to the List of Recognized Standards, Recognition List
Number: 059
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: 059'' 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: 059.
Table 1--Modifications to the List of Recognized Standards
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Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
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A. Anesthesiology
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1-67........... 1-153 NFPA 99:2021 Health Withdrawn and
Care Facilities Code. replaced with
newer version.
1-78........... 1-154 ASME PVHO-1-2019 Withdrawn and
Safety Standard for replaced with
Pressure Vessels for newer version.
Human Occupancy.
1-132.......... 1-155 ISO 10079-2 Fourth Withdrawn and
edition 2022-03 replaced with
Medical suction newer version.
equipment--Part 2:
Manually powered
suction equipment.
1-133.......... 1-156 ISO 10079-3 Fourth Withdrawn and
edition 2022-03 replaced with
Medical suction newer version.
equipment--Part 3:
Suction equipment
powered from a
vacuum or positive
pressure gas source.
1-142.......... 1-157 ISO 10079-1 Fourth Withdrawn and
edition 2022-03 replaced with
Medical suction newer version.
equipment--Part 1:
Electrically powered
suction equipment.
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B. Biocompatibility
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2-93........... 2-297 ASTM F763-22 Standard Withdrawn and
Practice for Short- replaced with
Term Intramuscular newer version.
Screening of
Implantable Medical
Device Materials.
2-276.......... 2-298 ISO 10993-18 Second Withdrawn and
edition 2020-01 replaced with
Amendment 1:2022-05 newer version,
Biological including
evaluation of amendment.
medical devices--
Part 18: Chemical
characterization of
medical device
materials within a
risk management
process [Including
Amendment 1 (2022)].
2-289.......... .............. ISO 10993-12 Fifth Transition
edition 2021-01 period
Biological extended.
evaluation of
medical devices--
Part 12: Sample
preparation and
reference materials.
2-296.......... .............. ISO 10993-10 Fourth Transition
edition 2021-11 period
Biological extended.
evaluation of
medical devices--
Part 10: Tests for
skin sensitization.
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C. Cardiovascular
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No new entries at this time.
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D. Dental/Ear, Nose, and Throat
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4-234.......... 4-294 ANSI/ADA Standard No. Withdrawn and
139-2020 Dental Base replaced with
Polymers. newer version.
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E. General I (Quality Systems/Risk Management) (QS/RM)
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15-135......... 5-135 ISO 20417 First New recognition
edition 2021-04 number.
Corrected version
2021-12 Medical
devices--Information
to be supplied by
the manufacturer.
5-99........... 5-136 ASTM D4332-22 Withdrawn and
Standard Practice replaced with
for Conditioning newer version.
Containers,
Packages, or
Packaging Components
for Testing.
5-104.......... 5-137 IEC TR 60878 Edition Withdrawn and
4.0 2022-11 replaced with
Graphical symbols newer version.
for electrical
equipment in medical
practice.
5-118.......... 5-138 AAMI TIR66:2017/ New recognition
(R)2020 Guidance for number.
the creation of
physiologic data and
waveform databases
to demonstrate
reasonable assurance
of the safety and
effectiveness of
alarm system
algorithms.
5-119.......... 5-139 ISO 18250-3 First New recognition
edition 2018-06 number.
Medical devices--
Connectors for
reservoir delivery
systems for
healthcare
applications--Part
3: Enteral
application.
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F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-29.......... 19-48 IEEE ANSI/USEMCSC Withdrawn and
C63.27 American replaced with
National Standard newer version.
for Evaluation of
Wireless Coexistence.
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[[Page 50873]]
G. General Hospital/General Plastic Surgery (GH/GPS)
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6-390.......... .............. IEC 80601-2-35 Withdrawn. See 6-
Edition 2.1 2016-04 483.
CONSOLIDATED VERSION
Medical electrical
equipment-Part--2-
35: Particular
requirements for the
basic safety and
essential
performance of
heating devices
using blankets, pads
or mattresses and
intended for heating
in medical use
[Including Amendment
1 (2016)].
6-460.......... 6-484 ASTM F3502-22a Extent of
Standard recognition.
Specification for Withdrawn and
Barrier Face replaced with a
Coverings. newer version.
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H. In Vitro Diagnostics (IVD)
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7-291.......... 7-313 CLSI EP27 2nd Edition Extent of
Constructing and recognition.
Interpreting an Withdrawn and
Error Grid for replaced with
Quantitative newer version.
Measurement
Procedures.
7-303.......... .............. CLSI M60 2nd Edition Withdrawn. See 7-
Performance 314.
Standards for
Antifungal
Susceptibility
Testing of Yeast.
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I. Materials
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8-61........... 8-594 ISO 5832-6 Third Withdrawn and
Edition 2022-03 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 6:
Wrought cobalt-
nickel-chromium-
molybdenum alloy.
8-123.......... 8-595 ISO 5832-5 Fourth Withdrawn and
Edition 2022-03 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 5:
Wrought cobalt-
chromium-tungsten-
nickel.
8-559.......... 8-596 ASTM D412-16(2021) Withdrawn and
Standard Test replaced with
Methods for newer version.
Vulcanized Rubber
and Thermoplastic
Elastomers--Tension.
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J. Nanotechnology
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18-4........... 18-21 ISO/TS 80004-6 Second Withdrawn and
edition 2021-03 replaced with
Nanotechnologies--Vo newer version.
cabulary--Part 6:
Nano-object
characterization.
18-12.......... 18-22 ISO 17200 First Withdrawn and
edition 2020-09 replaced with
Nanotechnology--Nano newer version.
particles in powder
form--Characteristic
s and measurements.
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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)
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9-89........... .............. ISO 8638 Third Withdrawn. See 9-
edition 2010-07-01 140.
Cardiovascular
implants and
extracorporeal
systems--Extracorpor
eal blood circuit
for hemodialyzers,
hemodialfilters, and
hemofilters.
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M. Ophthalmic
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10-37.......... 10-132 ISO 10942 Third Extent of
edition 2022-01 recognition.
Ophthalmic Withdrawn and
instruments--Direct replaced with
ophthalmoscopes. newer version.
10-91.......... 10-133 ISO 11979-10 Second Withdrawn and
edition 2018-03 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 10: Clinical
investigations of
intraocular lenses
for correction of
ametropia in phakic
eyes.
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N. Orthopedic
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11-264......... 11-394 ASTM F1820-22 Withdrawn and
Standard Test Method replaced with
for Determining the newer version.
Forces for
Disassembly of
Modular Acetabular
Devices.
11-306......... 11-395 ASTM F1814-22 Withdrawn and
Standard Guide for replaced with
Evaluating Modular newer version.
Hip and Knee Joint
Components.
11-320......... 11-396 ISO 7206-13 First Withdrawn and
edition 2016-07-01 replaced with
[Including newer version
AMD1:2022] Implants including
for surgery--Partial amendment.
and total hip joint
prostheses--Part 13:
Determination of
resistance to torque
of head fixation of
stemmed femoral
components
[Including Amendment
1 (2022)].
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O. Physical Medicine
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16-191......... .............. ISO 7176-16 Second Withdrawn. See
edition 2012-12-01 16-233.
Wheelchairs--Part
16: Resistance to
ignition of postural
support devices.
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P. Radiology
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12-113......... 12-346 ISO 12005 Third Withdrawn and
edition 2022-05 replaced with
Lasers and laser- newer version.
related equipment--
Test methods for
laser beam
parameters--Polariza
tion.
[[Page 50874]]
12-295......... 12-347 IEC 60601-2-33 Extent of
Edition 4.0 2022-08 recognition.
Medical electrical Withdrawn and
equipment--Part 2- replaced with
33: Particular newer version.
requirements for the
basic safety and
essential
performance of
magnetic resonance
equipment for
medical diagnosis.
12-317......... 12-348 IEC 60601-2-54 Extent of
Edition 2.0 2022-09 recognition.
Medical electrical Withdrawn and
equipment--Part 2- replaced with
54: Particular newer version.
requirements for the
basic safety and
essential
performance of X-ray
equipment for
radiography and
radioscopy.
12-342......... 12-349 NEMA Digital Imaging Withdrawn and
and Communications replaced with
in Medicine (DICOM) newer version.
Set PS3.1-3.20 2022d.
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Q. Software/Informatics
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13-109......... 13-121 ANSI/AAMI/UL 2800- Withdrawn and
1:2022 Standard for replaced with
Medical Device newer version.
Interoperability. See 13-125, 13-
126, 13-127.
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R. Sterility
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14-409......... 14-580 ISO 11137-2 Third Withdrawn and
edition 2013-06 replaced with
[Including newer version.
AMD1:2022]
Sterilization of
health care
products--Radiation-
-Part 2:
Establishing the
sterilization dose
[Including Amendment
1 (2022)].
14-527......... 14-581 ASTM F2638-22 Withdrawn and
Standard Test Method replaced with
for Using Aerosol newer version.
Filtration for
Measuring the
Performance of
Porous Packaging
Materials as a
Surrogate Microbial
Barrier.
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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: 059. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
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Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
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1-158................ Medical suction equipment-- ISO 10079-4 First
Part 4: General edition 2021-08.
requirements.
1-159................ Respiratory equipment-- ISO 18778 Second
Particular requirements edition 2022-06.
for basic safety and
essential performance of
infant cardiorespiratory
monitors.
1-160................ Medical electrical ISO 80601-2-84 First
equipment--Part 2-84: edition 2020-07.
Particular requirements
for the basic safety and
essential performance of
ventilators for the
emergency medical
services environment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
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C. Cardiovascular
------------------------------------------------------------------------
3-183................ Cardiovascular implants ISO 11658 First
and extracorporeal edition 2012-05-15.
systems--Blood/tissue
contact surface
modifications for
extracorporeal perfusion
systems.
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D. Dental/ENT
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4-295................ Evaluation of ANSI/ADA Standard No.
biocompatibility of 41-2020.
medical devices used in
dentistry.
4-296................ Dentistry--Intra-oral ISO 9873 Fourth
mirrors. edition 2019-03.
4-297................ Dentistry--Manual ISO 20126 Third
toothbrushes--General edition 2022-03.
requirements and test
methods.
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E. General I (QS/RM)
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5-140................ Standard for verification ASME V&V 10-2019.
and validation in
computational solid
mechanics.
5-141................ Standard for verification ASME V&V 20-2009
and validation in (R2021).
computational fluid
dynamics and heat
transfer.
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[[Page 50875]]
F. General II (ES/EMC)
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No new entries at this time.
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G. GH/GPS
------------------------------------------------------------------------
6-483................ Medical electrical IEC 60601-2-35
equipment--Part 2-35: Edition 2.0 2020-09.
Particular requirements
for the basic safety and
essential performance of
heating devices using
blankets, pads and
mattresses and intended
for heating in medical
use.
6-485................ Sterile hypodermic ISO 7886-4 Second
syringes for single use-- Edition 2018-11.
Part 4: Syringes with re-
use prevention feature.
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H. IVD
------------------------------------------------------------------------
7-314................ Performance Standards for CLSI M27M44S, 3rd
Antifungal Susceptibility Edition.
Testing of Yeasts.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-140................ Extracorporeal systems for ISO 8637-2 First
blood purification--Part Edition 2018-07.
2: Extracorporeal blood
circuit for
hemodialyzers,
hemodiafilters and
hemofilters.
9-141................ Extracorporeal systems for ISO 8637-3 First
blood purification--Part Edition 2018-07.
3: Plasmafilters.
9-142................ Standard test method for ASTM D1894-14.
static and kinetic
coefficients of friction
of plastic film and
sheeting.
9-143................ Sterile urethral catheters ISO 20696 First
for single use. edition 2018-06
Corrected 2019-12.
9-144................ Sterile drainage catheters ISO 20697 First
and accessory devices for edition 2018-06
single use. Corrected 2019-09.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-397............... Standard test method for ASTM F3210-22e1.
fatigue testing of total
knee femoral components
under closing conditions.
11-398............... Standard test methods for ASTM F3574-22.
sacroiliac joint fusion
devices.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-233............... Wheelchair seating--Part ISO 16840-10 Second
10: Resistance to edition 2021-06
ignition of postural Corrected version
support devices-- 2022-01.
Requirements and test
method.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-122............... Health software and health IEC 81001-5-1 Edition
IT systems safety, 1.0 2021-12.
effectiveness and
security--Part 5-1:
Security--Activities in
the product life cycle.
13-123............... Manufacturer disclosure ANSI/NEMA HN 1-2019.
statement for medical
device security.
13-124............... Guidance on the AAMI CR34971:2022.
application of ISO 14971
to artificial
intelligence and machine
learning.
13-125............... Standard for risk concerns ANSI/AAMI/UL 2800-1-
for interoperable medical 1:2022.
products.
13-126............... Standard for interoperable ANSI/AAMI/UL 2800-1-
item development life 2:2022.
cycle.
13-127............... Standard for Interoperable ANSI/AAMI/UL 2800-1-
item integration life 3:2022.
cycle.
13-128............... IEEE/UL Standard for IEEE Std 2621.2-2022/
wireless diabetes device UL 2621-2:2022.
security: Information
security requirements for
connected diabetes
solutions.
------------------------------------------------------------------------
[[Page 50876]]
R. Sterility
------------------------------------------------------------------------
14-582............... Sterilization of health ISO/TS 11137-4 First
care products--Radiation-- edition 2020-06.
Part 4: Guidance on
process control.
14-583............... Cleaning validation of ANSI/AAMI ST98:2022.
health care products--
Requirements for
development and
validation of a cleaning
process for 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: July 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16418 Filed 8-1-23; 8:45 am]
BILLING CODE 4164-01-P