[Federal Register Volume 91, Number 162 (Monday, August 24, 2026)]
[Notices]
[Pages 54715-54721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-17229]
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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: 066
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the 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: 066'' (Recognition List Number: 066), 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 August 24, 2026.
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
[[Page 54716]]
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: 066.'' 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: 066.
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: 066 is available on
the internet at https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/federal-register-documents. See section IV
for electronic access to the searchable database for the current list
of FDA-recognized consensus standards, including Recognition List
Number: 066 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: 066'' to Terry Woods, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5612, Silver Spring, MD 20993, 301-796-2503. 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: Terry Woods, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5612, Silver Spring, MD 20993, 301-796-2503,
[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 Division of Standards and
Conformity Assessment is available at https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 066
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: 066'' 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 of this notice, 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: 066.
[[Page 54717]]
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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1-157............ 1-203 ISO 10079-1 Fourth Withdrawn and
edition 2022-03 replaced with
[Including AMD1:2026] newer version.
Medical suction
equipment--Part 1:
Electrically powered
suction equipment
[Including Amendment
1 (2026)].
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B. Biocompatibility
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2-258............ 2-313 ISO 10993-1 Sixth Withdrawn and
edition 2025-11 replaced with
Biological evaluation newer version.
of medical devices--
Part 1: Requirements
and general
principles for the
evaluation of
biological safety
within a risk
management process.
2-289............ 2-314 ISO 10993-12 Fifth Withdrawn and
edition 2021-01 replaced with
[Including AMD1:2025] newer version.
Biological evaluation
of medical devices--
Part 12: Sample
preparation and
reference materials
[Including AMENDMENT
1 (2025)].
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C. Cardiovascular
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3-173............ 3-204 ISO 5840-3 Second Withdrawn and
edition 2021-01 replaced with
[Including AMD1:2025] newer version.
Cardiovascular
implants--Cardiac
valve prostheses--
Part 3: Heart valve
substitutes implanted
by transcatheter
techniques
[Including: AMENDMENT
1 (2025)].
3-174............ 3-205 ISO 5840-1 Second Withdrawn and
edition 2021-01 replaced with
[Including AMD1:2025] newer version.
Cardiovascular
implants--Cardiac
valve prostheses--
Part 1: General
requirements
[Including: AMENDMENT
1 (2025)].
3-175............ 3-206 ISO 5840-2 Second Withdrawn and
edition 2021-01 replaced with
[Including AMD1:2025] newer version.
Cardiovascular
implants--Cardiac
valve prostheses--
Part 2: Surgically
implanted heart valve
substitutes
[Including: AMENDMENT
1 (2025)].
3-189............ 3-207 ASTM F2942-25 Standard Withdrawn and
Guide for in vitro replaced with
Axial, Bending, newer version.
Torsional, and
Compression
Durability Testing of
Vascular Stents and
Vascular Stent-Grafts.
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D. Dental/Ear, Nose, and Throat (ENT)
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4-278............ 4-368 ISO 4823 Sixth edition Withdrawn and
2025-06 Dentistry-- replaced with
Elastomeric newer version.
impression and bite
registration
materials.
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E. General I (Quality Systems/Risk Management) (QS/RM)
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5-135............ 5-149 ISO 20417 Second Withdrawn and
edition 2026-03 replaced with
Medical devices-- newer version.
Information to be
supplied by the
manufacturer.
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F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
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G. General Hospital/General Plastic Surgery (GH/GPS)
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6-389............ 6-521 IEC 60601-2-2 Edition Extent of
6.1 2023-02 recognition.
CONSOLIDATED VERSION Withdrawn and
Corrected Version replaced with
2025-11 Medical newer version.
electrical equipment--
Part 2-2: Particular
requirements for the
basic safety and
essential performance
of high frequency
surgical equipment
and high frequency
surgical accessories.
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H. In Vitro Diagnostics (IVD)
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No new entries at this time.
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I. Materials
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8-485............ 8-647 ASTM F3260-25 Standard Withdrawn and
Test Method for replaced with
Determining the newer version.
Flexural Stiffness of
Medical Textiles.
8-520............ 8-648 ASTM F799-25 Standard Withdrawn and
Specification for replaced with
Cobalt-28 Chromium-6 newer version.
Molybdenum Alloy
Forgings for Surgical
Implants (UNS R31537,
R31538, R31539).
8-602............ 8-649 ASTM F2503-26 Standard Withdrawn and
Practice for Marking replaced with
Medical Devices and newer version.
Other Items for
Safety in the
Magnetic Resonance
Environment.
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[[Page 54718]]
J. Nanotechnology
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18-16............ 18-25 ISO 21362 First Withdrawn and
edition 2026-02 replaced with
Nanotechnologies--Ana newer version.
lysis of nano-objects
using asymmetrical
flow and centrifugal
field-flow
fractionation.
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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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9-133............ 9-152 ISO 23500-1 Second Extent of
edition 2024-08 recognition.
Preparation and Withdrawn and
quality management of replaced with
fluids for newer version.
haemodialysis and
related therapies--
Part 1: General
requirements.
9-134............ 9-153 ISO 23500-2 Second Withdrawn and
edition 2024-07 replaced with
Preparation and newer version.
quality management of
fluids for
haemodialysis and
related therapies--
Part 2: Water
treatment equipment
for haemodialysis
applications and
related therapies.
9-135............ 9-154 ISO 23500-3 Second Withdrawn and
edition 2024-04 replaced with
Preparation and newer version.
quality management of
fluids for
haemodialysis and
related therapies--
Part 3: Water for
haemodialysis and
related therapies.
9-136............ 9-155 ISO 23500-4 Second Extent of
edition 2024-04 recognition.
Preparation and Withdrawn and
quality management of replaced with
fluids for newer version.
haemodialysis and
related therapies--
Part 4: Concentrates
for haemodialysis and
related therapies.
9-137............ 9-156 ISO 23500-5 Second Withdrawn and
edition 2024-04 replaced with
Preparation and newer version.
quality management of
fluids for
haemodialysis and
related therapies--
Part 5: Quality of
dialysis fluid for
haemodialysis and
related therapies.
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M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
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N. Orthopedic
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11-175........... ............ ASTM F1582-98 Withdrawn.
(Reapproved 2016)
Standard Terminology
Relating to Spinal
Implants.
11-247........... 11-441 ASTM F2789-25 Standard Withdrawn and
Guide for Mechanical replaced with
and Functional newer version.
Characterization of
Nucleus Devices.
11-290........... ............ ISO 8828 Second Withdrawn.
edition 2014-11-15
Implants for surgery--
Guidance on care and
handling of
orthopaedic implants.
11-319........... 11-442 ISO 7206-12 Second Withdrawn and
edition 2025-11 replaced with
Implants for surgery-- newer version.
Partial and total hip
joint prostheses--
Part 12: Deformation
test method for press-
fit acetabular
components.
11-346........... 11-443 ASTM F2706-25 Standard Withdrawn and
Test Methods for replaced with
Occipital-Cervical newer version.
and Occipital-
Cervical-Thoracic
Spinal Implant
Constructs in a
Vertebrectomy Model.
11-353........... 11-444 ISO 18192-3 Second Withdrawn and
edition 2025-11 replaced with
Implants for surgery-- newer version.
Wear of total
intervertebral spinal
disc prostheses--Part
3: Impingement-wear
testing and
corresponding
environmental
conditions for test
of lumbar and
cervical prostheses.
11-371........... 11-445 ASTM F2009-25 Standard Withdrawn and
Test Method for replaced with
Determining the Axial newer version.
Disassembly Force of
Taper Connections of
Modular Prostheses.
11-398........... 11-446 ASTM F3574-25 Standard Withdrawn and
Test Methods for replaced with
Sacroiliac Joint newer version.
Fusion Devices.
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O. Physical Medicine
------------------------------------------------------------------------
16-166........... 16-240 ISO 7176-21 Third Withdrawn and
edition 2025-04 replaced with
Wheelchairs--Requirem newer version.
ents and test methods
for electromagnetic
compatibility of
electrically powered
wheelchairs and
scooters, and battery
chargers.
------------------------------------------------------------------------
P. Radiology
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12-51, 12-303.... 12-386 IEC 63465 Edition 1.0 Withdrawn and
2026-01 Calibration replaced with
and quality control newer version.
in the use of
radionuclide
calibrators.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-106........... 13-157 IEEE Std. 11073-10207- Withdrawn and
2017 [Including Cor 1- replaced with
2025] Standard Health newer version.
informatics--Point of
care medical device
communication Part
10207: Domain
Information and
Service Model for
Service-Oriented
Point-of-Care Medical
Device Communication
[Including
Corrigendum 1 (2025)].
[[Page 54719]]
13-142........... ............ FIRST CVSS 3.1 Common Transition
Vulnerability Scoring period
System version 3.1. extended.
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R. Sterility
------------------------------------------------------------------------
No new entries at this time.
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S. Tissue Engineering
------------------------------------------------------------------------
15-52............ 15-70 ASTM F2064-25 Standard Withdrawn and
Guide for replaced with
Characterization and newer version.
Testing of Alginates
as Starting Materials
Intended for Use in
Biomedical and Tissue
Engineered Medical
Product Applications.
------------------------------------------------------------------------
\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: 066. 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
------------------------------------------------------------------------
No new entries at this time.
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C. Cardiovascular
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No new entries at this time.
------------------------------------------------------------------------
D. Dental/ENT
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4-369.............. Periodontal Curettes, ANSI/ADA Standard No.
Dental Scalers and 113-2015.
Excavators.
4-370.............. Casting Investments and ANSI/ADA Standard No.
Refractory Die Materials. 126-2015 (R2023).
4-371.............. Denture Adhesives.......... ANSI/ADA Standard No.
135-2015 (R2020).
4-372.............. Dentistry--Dental ANSI/ADA Standard No.
Duplicating Material. 141-2013 (R2023).
4-373.............. Periodontal Probes--Dental ANSI/ADA Standard No.
Excavators--Discoid Type: 170-2019.
General Requirements.
4-374.............. Dental Tweezers............ ANSI/ADA Standard No.
195-2021.
4-375.............. Spoons and Bone Curettes in ANSI/ADA Standard No.
Dentistry. 197-2021.
4-376.............. Dentistry--Dental explorer. ISO 7492 Fourth
edition 2019-03.
4-377.............. Dentistry--Extraction ISO 9173-1 Third
forceps--Part 1: General edition 2016-10.
requirements.
4-378.............. Dentistry--Extraction ISO 9173-2 First
forceps--Part 2: edition 2010-05.
Designation.
4-379.............. Dentistry--Extraction ISO 9173-3 First
forceps--Part 3: Design. edition 2014-05.
4-380.............. Dentistry--Magnetic ISO 13017 Second
attachments. edition 2020-07.
4-381.............. Dentistry--Dental furnace-- ISO 13078 First
Test method for edition 2013-02.
temperature measurement
with separate thermocouple.
4-382.............. Dentistry--Dental furnace-- ISO 13078-2 First
Part 2: Test method for edition 2016-07.
evaluation of furnace
programme via firing glaze.
4-383.............. Dentistry--Dental furnace-- ISO 13078-3 First
Part 3: Test method for edition 2023-05.
the evaluation of high
temperature sintering
furnace measurement with a
separate thermocouple.
4-384.............. Periodontal curettes, ISO 13397-1 First
dental scalers and edition 1995-12.
excavators--Part 1:
General requirements.
4-385.............. Dentistry--Periodontal ISO 13397-2 Second
curettes, dental scalers edition 2005-06
and excavators--Part 2: [Including
Periodontal curettes of Gr- AMD1:2012].
type [Including AMENDMENT
1 (2012)].
4-386.............. Periodontal curettes, ISO 13397-3 First
dental scalers and edition 1996-09.
excavators--Part 3: Dental
scalers--H-type.
4-387.............. Dentistry--Periodontal ISO 13397-5 First
curettes, dental scalers edition 2015-09.
and excavators--Part 5:
Jacquette scalers.
4-388.............. Dentistry--Duplicating ISO 14356 Second
material. edition 2024-10.
4-389.............. Dentistry--Dental tweezers. ISO 15098 Second
edition 2024-07.
4-390.............. Dentistry--Refractory ISO 15912 Second
investment and die edition 2016-01.
material.
[[Page 54720]]
4-391.............. Dentistry--Minimal dental ISO 16498 First
implant data set for edition 2013-07.
clinical use.
4-392.............. Dentistry--Coiled springs ISO 17254 First
for use in orthodontics edition 2016-07
[Including AMENDMENT 1 [Including
(2020)]. AMD1:2020].
4-393.............. Dentistry--Reprocessable ISO 21533 Second
cartridge syringes for edition 2018-01.
intraligamentary
injections.
4-394.............. Dentistry--Periodontal ISO 21672-1 First
probes--Part 1: General edition 2012-04.
requirements.
4-395.............. Dentistry--Materials for ISO 21850-1 First
dental instruments--Part edition 2020-04.
1: Stainless steel.
4-396.............. Dentistry--Spoons and bone ISO 22570 First
curettes. edition 2020-02.
4-397.............. Dentistry--Test methods for ISO 23298 First
machining accuracy of edition 2023-05.
computer-aided milling
machines.
4-398.............. Dentistry--Excavators...... ISO 23940 First
edition 2021-04.
4-399.............. Dentistry--Bonding test ISO TS 19736 First
between polymer teeth and edition 2017-09.
denture base materials.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-650.............. Standard Guide for Content ASTM F3766-25.
and Format of Test Report
Summaries for Medical and
Surgical Materials and
Device Standards.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-23.............. Medical electrical IEC 80601-2-26 First
equipment--Part 2-26: Edition 2024-03
Particular requirements CONSOLIDATED VERSION.
for the basic safety and
essential performance of
electroencephalographs.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-241............. Wheelchairs--Part 31: ISO 7176-31 First
Lithium-ion battery edition 2023-05.
systems and chargers for
powered wheelchairs--
Requirements and test
methods.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-158............. Open Mobile Health Data-- IEEE Std 1752.1-2021.
Representation of
Metadata, Sleep, and
Physical Activity Measures.
------------------------------------------------------------------------
[[Page 54721]]
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
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.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17229 Filed 8-21-26; 8:45 am]
BILLING CODE 4164-01-P