[Federal Register Volume 90, Number 121 (Thursday, June 26, 2025)]
[Notices]
[Pages 27312-27319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-11792]
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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: 064
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: 064'' (Recognition List Number: 064), 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 June 26, 2025.
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: 064.'' 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: 064.
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: 064 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: 064 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: 064'' to Terry Woods, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, 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, 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
[[Page 27313]]
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/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 064
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: 064'' 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: 064.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-120............ 1-193 ISO 18190 Second Withdrawn and
edition 2025-02 replaced with
Anaesthetic and newer version.
respiratory
equipment--General
requirements for
airway devices and
related equipment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-136............ 2-305 ASTM E1262-24 Withdrawn and
Standard Guide for replaced with
Performance of newer version.
Chinese Hamster
Ovary Cell/
Hypoxanthine Guanine
Phosphoribosyl
Transferase Gene
Mutation Assay.
2-145............ 2-306 ASTM F1439-24 Withdrawn and
Standard Guide for replaced with
Performance of newer version.
Lifetime Bioassay
for the Tumorigenic
Potential of Implant
Materials.
2-246............ 2-307 ASTM F1877-24 Withdrawn and
Standard Practice replaced with
for Characterization newer version.
of Particles.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-103............ 3-198 ISO 25539-3 Second Withdrawn and
edition 2024-10 replaced with
Cardiovascular newer version.
implants--Endovascul
ar devices--Part 3:
Vena cava filters.
3-165............ 3-199 ASTM F1841-25 Withdrawn and
Standard Practice replaced with
for Assessment of newer version.
Hemolysis in Blood
Pumps.
3-184............ 3-200 ASTM F2477-24 Withdrawn and
Standard Test replaced with
Methods for in vitro newer version.
Pulsatile Durability
Testing of Vascular
Stents and
Endovascular
Prostheses.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-293............ 4-339 ANSI/ADA Standard No. Withdrawn and
119-2023 Dentistry-- replaced with
Manual Toothbrushes. newer version.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-97............. 5-144 ISO 80369-20 Second Withdrawn and
edition 2024-11 replaced with
Small-bore newer version.
connectors for
liquids and gases in
healthcare
applications--Part
20: Common test
methods.
5-102............ 5-145 IEC 60417:2025 DB Withdrawn and
Graphical symbols replaced with
for use on equipment. newer version.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-24............ 19-54 IEC 60086-5 Edition Withdrawn and
5.0 2021-09 Primary replaced with
batteries--Part 5: newer version.
Safety of batteries
with aqueous
electrolyte
[Including
Corrigendum 1
(2022)].
[[Page 27314]]
19-33............ 19-55 IEC 62133-2 Edition Withdrawn and
1.1 2021-07 replaced with
CONSOLIDATED VERSION newer version.
Secondary cells and
batteries containing
alkaline or other
non-acid
electrolytes--Safety
requirements for
portable sealed
secondary cells, and
for batteries made
from them, for use
in portable
applications--Part
2: Lithium systems.
19-40............ 19-56 IEC 60086-4 Edition Withdrawn and
6.0 2025-01 Primary replaced with
batteries--Part 4: newer version.
Safety of lithium
batteries.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-179............ 6-505 ISO 21649 Second Withdrawn and
edition 2023-01 replaced with
Needle-free newer version.
injection systems
for medical use--
Requirements and
test methods.
6-242............ 6-506 ISO 8536-2 Fourth Withdrawn and
edition 2023-01 replaced with
Infusion equipment newer version.
for medical use--
Part 2: Closures for
infusion bottles.
6-273............ 6-507 ISO 23908 Second Withdrawn and
edition 2024-12 replaced with
Sharps injury newer version.
protection--Sharps
protection
mechanisms for
single-use needles,
introducers for
catheters and
needles used for
blood testing,
monitoring, sampling
and medical
substance
administration--Requ
irements and test
methods.
6-405............ 6-508 IEC 80601-2-59 Withdrawn and
Edition 2.1 2023-01 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-
59: Particular
requirements for the
basic safety and
essential
performance of
screening
thermographs for
human febrile
temperature
screening.
6-407............ 6-509 ASTM F3186-24 Withdrawn and
Standard replaced with
Specification for newer version.
Adult Portable Bed
Rails and Related
Products.
6-438............ 6-510 IEC 80601-2-77 Withdrawn and
Edition 1.1 2023-11 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-
77: Particular
requirements for the
basic safety and
essential
performance of
robotically assisted
surgical equipment.
6-464............ 6-511 ISO 11040-4 Fourth Withdrawn and
edition 2024-06 replaced with
Prefilled syringes-- newer version.
Part 4: Glass
barrels for
injectables and
sterilized
subassembled
syringes ready for
filling.
6-483............ 6-512 IEC 60601-2-35 Withdrawn and
Edition 2.1 2023-12 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-
35: Particular
requirements for the
basic safety and
essential
performance of
heating devices
using blankets pads
and mattresses and
intended for heating
in medical use.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-327............ 7-328 CLSI M100 35th Withdrawn and
Edition Performance replaced with
Standards for newer version.
Antimicrobial
Susceptibility
Testing.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-4............. 17-21 ASTM F647-22 Standard Withdrawn and
Practice for replaced with
Evaluating and newer version.
Specifying
Implantable Shunt
Assemblies for
Neurosurgical
Application.
------------------------------------------------------------------------
17-16............ 17-22 IEC 60601-2-10 Withdrawn and
Edition 2.2 2023-01 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-
10: Particular
requirements for the
basic safety and
essential
performance of nerve
and muscle
stimulators.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-98............ 10-137 ISO 11979-2 Third Withdrawn and
edition 2024-10 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 2: Optical
properties and test
methods.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-344........... 11-420 ASTM F2580-24 Withdrawn and
Standard Test Method replaced with
for Evaluation of newer version.
Modular Connection
of Proximally Fixed
Femoral Hip
Prostheses.
[[Page 27315]]
11-347........... 11-421 ASTM F2077-24 Withdrawn and
Standard Test replaced with
Methods for newer version.
Intervertebral Body
Fusion Devices.
11-402........... 11-422 ASTM F1798-24 Withdrawn and
Standard Test Method replaced with
for Evaluating the newer version.
Static and Fatigue
Properties of
Interconnection
Mechanisms and
Subassemblies Used
in Spinal
Arthrodesis Implants.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-115........... 12-367 ISO 13695 Second Withdrawn and
edition 2024-11 replaced with
Optics and newer version.
photonics--Lasers
and laser-related
equipment--Test
methods for the
spectral
characteristics of
lasers.
12-116........... 12-368 ISO 13696 Second Withdrawn and
edition 2022-06 replaced with
Optics and newer version.
photonics--Test
methods for
radiation scattered
by optical
components.
12-134........... 12-369 ISO 11146-1 Second Withdrawn and
edition 2021-07 replaced with
Lasers and laser- newer version.
related equipment--
Test methods for
laser beamwidths,
divergence angles
and beam propagation
ratios--Part 1:
Stigmatic and simple
astigmatic beams.
12-142........... 12-370 ISO 11146-2 Second Withdrawn and
edition 2021-07 replaced with
Lasers and laser- newer version.
related equipment--
Test methods for
laser beamwidths,
divergence angles
and beam propagation
ratios--Part 2:
General astigmatic
beams.
12-171........... 12-371 ISO 14880-2 Second Withdrawn and
edition 2024-11 replaced with
Optics and newer version.
photonics--Microlens
arrays--Part 2: Test
methods for
wavefront
aberrations.
12-172........... 12-372 ISO 14880-3 Second Withdrawn and
edition 2024-11 replaced with
Optics and newer version.
photonics--Microlens
arrays--Part 3: Test
methods for optical
properties other
than wavefront
aberrations.
12-173........... 12-373 ISO 14880-4 Second Withdrawn and
edition 2024-11 replaced with
Optics and newer version.
photonics--Microlens
arrays--Part 4: Test
methods for
geometrical
properties.
12-175........... 12-374 ISO 24013 Second Withdrawn and
edition 2023-06 replaced with
Optics and newer version.
photonics--Lasers
and laser-related
equipment--Measureme
nt of phase
retardation of
optical components
for polarized laser
radiation.
12-177........... 12-375 ANSI/UL 122-2019 Withdrawn and
Standard for Safety replaced with
Photographic newer version.
Equipment--Ed. 5.0
[Including revisions
through October 15,
2019].
12-266........... 12-376 IEC 61689 Edition 4.0 Withdrawn and
2022-03 Ultrasonics-- replaced with
Physiotherapy newer version.
systems--Field
specifications and
methods of
measurement in the
frequency range 0.5
MHz to 5 MHz.
12-279........... 12-377 IEC 62127-03 Edition Withdrawn and
2.0 2022-12 replaced with
Ultrasonics--Hydroph newer version.
ones--Part 3:
Properties of
hydrophones for
ultrasonic fields.
12-282........... 12-378 ISO 12609-1 Second Withdrawn and
edition 2021-10 Eye replaced with
and face protection newer version.
against intense
light sources used
on humans and
animals for cosmetic
and medical
applications--Part
1: Specification for
products.
12-291........... 12-379 IEC 62127-2 Edition Withdrawn and
2.0 2025-01 replaced with
Ultrasonics--Hydroph newer version.
ones--Part 2:
Calibration for
ultrasonic fields.
12-293........... 12-380 IEC 60601-2-37 Withdrawn and
Edition 3.0 2024-07 replaced with
Medical electrical newer version.
equipment--Part 2-
37: Particular
requirements for the
basic safety and
essential
performance of
ultrasonic medical
diagnostic and
monitoring equipment.
12-319........... 12-381 IEC 60601-2-68 Second Withdrawn and
edition 2025-02 replaced with
Medical electrical newer version.
equipment--Part 2-
68: Particular
requirements for the
basic safety and
essential
performance of X-ray-
based image-guided
radiotherapy
equipment for use
with electron
accelerators, light
ion beam therapy
equipment and
radionuclide beam
therapy equipment.
12-326........... 12-382 NEMA NU 2-2024 Withdrawn and
Performance replaced with
Measurements of newer version.
Positron Emission
Tomographs.
12-337........... 12-383 NEMA NU 1-2023 Withdrawn and
Performance replaced with
Measurements of newer version.
Gamma Cameras.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-9............. ............ CLSI AUTO02-A2 Transferred. See
Laboratory 7-331.
Automation: Bar
Codes for Specimen
Container
Identification;
Approved Standard--
Second Edition.
13-10............ ............ CLSI AUTO01-A Transferred. See
Laboratory 7-332.
Automation: Specimen
Container/Specimen
Carrier; Approved
Standard.
13-12............ ............ CLSI AUTO04-A Transferred. See
Laboratory 7-333.
Automation: Systems
Operational
Requirements,
Characteristics, and
Information
Elements; Approved
Standard.
13-13............ ............ CLSI AUTO05-A Transferred. See
Laboratory 7-334.
Automation:
Electromechanical
Interfaces; Approved
Standard.
[[Page 27316]]
13-14............ ............ CLSI POCT01-A2 Point- Transferred. See
of-Care 7-335.
Connectivity;
Approved Standard--
Second Edition.
13-15............ ............ CLSI AUTO13-A2 Transferred. See
(Formerly GP19-A2) 7-345.
Laboratory
Instruments and Data
Management Systems:
Design of Software
User Interfaces and
End-User Software
Systems Validation,
Operation, and
Monitoring; Approved
Guideline--Second
Edition.
13-17............ ............ CLSI LIS02-A2 Transferred. See
Specification for 7-336.
Transferring
Information Between
Clinical Instruments
and Computer
Systems; Approved
Standard--Second
Edition.
13-25............ ............ CLSI AUTO08-A Transferred. See
Managing and 7-337.
Validating
Laboratory
Information Systems;
Approved Guideline.
13-26............ ............ CLSI AUTO10-A Transferred. See
Autoverification of 7-338.
Clinical Laboratory
Test Results;
Approved Guideline.
13-28............ ............ CLSI AUTO09-A Remote Transferred. See
Access to Clinical 7-339.
Laboratory
Diagnostic Devices
via the Internet;
Approved Standard.
13-29............ ............ CLSI LIS01-A2 Transferred. See
Specification for 7-340.
Low-Level Protocol
to Transfer Messages
Between Clinical
Laboratory
Instruments and
Computer Systems;
Approved Standard--
Second Edition.
13-30............ ............ CLSI AUTO03-A2 Transferred. See
Laboratory 7-341.
Automation:
Communications with
Automated Clinical
Laboratory Systems,
Instruments,
Devices, and
Information Systems;
Approved Standard--
Second Edition.
13-31............ ............ CLSI AUTO12-A Transferred. See
Specimen Labels: 7-342.
Content and
Location, Fonts, and
Label Orientation;
Approved Standard.
13-36............ 13-143 AAMI TIR45:2023 Withdrawn and
Guidance on the use replaced by
of AGILE practices newer version.
in the development
of medical device
software.
13-37............ ............ CLSI AUTO07-A Transferred. See
Laboratory 7-343.
Automation: Data
Content for Specimen
Identification;
Approved Standard.
13-56............ 13-147 IEEE Std 11073-10406- Withdrawn and
2023 Health replaced by
Informatics--Device newer version.
Interoperability
Part 10406: Personal
Health Device
Communication--Devic
e Specialization--
Basic
Electrocardiograph
(ECG) (1- to 3-lead
ECG).
13-72............ 13-144 IEEE Std 11073-10425- Withdrawn and
2023 Health replaced by
Informatics--Device newer version.
Interoperability
Part 10425: Personal
Health Device
Communication--Devic
e Specialization--
Continuous Glucose
Monitor (CGM).
13-81............ 13-145 IEEE Std 11073-10419- Withdrawn and
2023 Health replaced by
Informatics--Device newer version.
Interoperability
Part 10419: Personal
Health Device
Communication--Devic
e Specialization--
Insulin Pump.
13-84............ 13-146 IEEE Std 11073-10103- Withdrawn and
2023 Health replaced by
Informatics--Device newer version.
Interoperability
Part 10103:
Point[hyphen]of[hyph
en]Care Medical
Device
Communication--Nomen
clature--Implantable
Device, Cardiac.
13-85............ ............ CLSI AUTO11-A2 Transferred. See
Information 7-344.
Technology Security
of In Vitro
Diagnostic
Instruments and
Software Systems;
Approved Standard--
Second Edition.
13-88............ ............ ISO IEEE 11073-10417 Transferred. See
Third edition 2017- 13-90.
04 Health
informatics--Persona
l health device
communication--Part
10417: Device
specialization--Gluc
ose meter.
13-89............ ............ ISO IEEE 11073-10406 Transferred. See
First edition 2012- 13-56.
12-01 Health
informatics--Persona
l health device
communication--Part
10406: Device
specialization--Basi
c electrocardiograph
(ECG) (1- to 3-lead
ECG).
13-90............ 13-148 IEEE Std 11073-10417- Withdrawn and
2023 Health replaced by
Informatics--Device newer version.
Interoperability
Part 10417: Personal
Health Device
Communication--Devic
e Specialization--
Glucose Meter.
13-91............ ............ ISO IEEE 11073-10419 Transferred. See
First edition 2016- 13-81.
06-15 Health
informatics--Persona
l health device
communication--Part
10419: Device
specialization--Insu
lin pump.
13-95............ ............ ISO IEEE 11073-10425 Transferred. See
First edition 2016- 13-72.
06-15 Health
informatics--Persona
l health device
communication--Part
10425: Device
specialization--Cont
inuous glucose
monitor (CGM).
13-116........... 13-142 FIRST CVSS v3.1 Withdrawn and
Common Vulnerability replaced by
Scoring System. newer version.
13-142........... 13-140 FIRST CVSS v4.0 Withdrawn and
Common Vulnerability replaced by
Scoring System.. newer version.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-336........... ............ ISO 14161 Second Withdrawn with
edition 2009-09-15 transition. See
Sterilization of 14-610. Extent
health care of recognition.
products--Biological
indicators--Guidance
for the selection,
use and
interpretation of
results.
[[Page 27317]]
14-528........... 14-611 ISO 11137-1 Second Withdrawn and
edition 2025-04 replaced with
Sterilization of newer version.
health care
products--Radiation-
-Part 1:
Requirements for the
development,
validation and
routine control of a
sterilization
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.
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: 064. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-194.................... Anaesthetic and ISO 27427 Fourth
respiratory equipment-- edition 2023-07.
Nebulizing systems and
components.
1-195.................... Small-bore connectors ISO 80369-2 First
for liquids and gases edition 2024-09.
in healthcare
applications--Part 2:
Connectors for
respiratory
applications.
1-196.................... Medical electrical ISO 80601-2-90
equipment--Part 2-90: First edition 2021-
Particular requirements 08.
for basic safety and
essential performance
of respiratory high-
flow therapy equipment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-340.................... Dental Patient Chair.... ANSI/ADA Standard
No. 46-2016.
4-341.................... Stationary Dental Units ANSI/ADA Standard
and Patient Chairs-- No. 47-1-2021.
Part 1: General
Requirements.
4-342.................... Stationary Dental Units ANSI/ADA Standard
and Patient Chairs-- No. 47-2-2021.
Part 2: Air, Water,
Suction and Wastewater
Systems.
4-343.................... Elastomeric Auxiliaries ANSI/ADA Standard
for Use in Orthodontics. No. 105-2024.
4-344.................... Dentistry--Polymer-based ANSI/ADA Standard
Machinable Blanks. No. 186-2024.
4-345.................... Dentistry--Dental CAD/ ANSI/ADA Standard
CAM Machinable Ceramic No. 187-2024.
Blanks.
4-346.................... Dentistry--Operating ISO 9680 Fourth
lights. edition 2021-11.
4-347.................... Dentistry--Manual ISO 22254 First
toothbrushes--Resistanc edition 2005-08.
e of tufted portion to
deflection.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
6-513.................... Non-active surgical ISO 14607 Fourth
implants--Mammary Edition 2024-12.
implants--Specific
requirements.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
7-329.................... Developer Validation of CLSI EP06-EG 2nd
Linearity. Edition.
7-330.................... Performance Standards CLSI M38M51S 3rd
for Antifungal Edition
Susceptibility Testing
of Filamentous Fungi..
7-331.................... Laboratory Automation: CLSI AUTO02-A2.
Bar Codes for Specimen
Container
Identification;
Approved Standard--
Second Edition.
7-332.................... Laboratory Automation: CLSI AUTO01-A.
Specimen Container/
Specimen Carrier;
Approved Standard.
7-333.................... Laboratory Automation: CLSI AUTO04-A.
Systems Operational
Requirements,
Characteristics, and
Information Elements;
Approved Standard.
7-334.................... Laboratory Automation: CLSI AUTO05-A.
Electromechanical
Interfaces; Approved
Standard.
7-335.................... Point-of-Care CLSI POCT01-A2.
Connectivity; Approved
Standard--Second
Edition.
[[Page 27318]]
7-336.................... Specification for CLSI LIS02-A2.
Transferring
Information Between
Clinical Instruments
and Computer Systems;
Approved Standard--
Second Edition.
7-337.................... Managing and Validating CLSI AUTO08-A.
Laboratory Information
Systems; Approved
Guideline.
7-338.................... Autoverification of CLSI AUTO10-A.
Clinical Laboratory
Test Results; Approved
Guideline.
7-339.................... Remote Access to CLSI AUTO09-A.
Clinical Laboratory
Diagnostic Devices via
the Internet; Approved
Standard.
7-340.................... Specification for Low- CLSI LIS01-A2.
Level Protocol to
Transfer Messages
Between Clinical
Laboratory Instruments
and Computer Systems;
Approved Standard--
Second Edition.
7-341.................... Laboratory Automation: CLSI AUTO03-A2.
Communications with
Automated Clinical
Laboratory Systems,
Instruments, Devices,
and Information
Systems; Approved
Standard--Second
Edition.
7-342.................... Specimen Labels: Content CLSI AUTO12-A.
and Location, Fonts,
and Label Orientation;
Approved Standard.
7-343.................... Laboratory Automation: CLSI AUTO07-A.
Data Content for
Specimen
Identification;
Approved Standard.
7-344.................... Information Technology CLSI AUTO11-A2.
Security of In Vitro
Diagnostic Instruments
and Software Systems;
Approved Standard--
Second Edition.
7-345.................... Laboratory Instruments CLSI AUTO13-A2
and Data Management (Formerly GP19-
Systems: Design of A2).
Software User
Interfaces and End-User
Software Systems
Validation, Operation,
and Monitoring;
Approved Guideline--
Second Edition.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-20.................... Particular requirements IEC 60601-2-40
for the basic safety Third edition 2024-
and essential 12.
performance of
electromyographs and
evoked response
equipment.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-151.................... Standard Specification ASTM F1828-22.
for Ureteral Stents.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-138................... Ophthalmic instruments-- ISO 16971-1 First
Optical coherence edition 2024-11.
tomographs--Part 1:
Optical coherence
tomographs for the
posterior segment of
the human eye.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
14-610................... Sterilization of health ISO 11138-7 First
care products-- edition 2019-03.
Biological indicators--
Part 7: Guidance for
the selection, use and
interpretation of
results.
------------------------------------------------------------------------
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.
[[Page 27319]]
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: June 23, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11792 Filed 6-25-25; 8:45 am]
BILLING CODE 4164-01-P