[Federal Register Volume 90, Number 53 (Thursday, March 20, 2025)]
[Notices]
[Pages 13167-13174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-04711]
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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: 063
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 063'' (Recognition List Number: 063), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
[[Page 13168]]
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable March 20, 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: 063.'' 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: 063.
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: 063 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: 063 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: 063'' 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 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.
[[Page 13169]]
II. Modifications to the List of Recognized Standards, Recognition List
Number: 063
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: 063'' 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: 063.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-153........... 1-180 NFPA 99:2024 Health Withdrawn and
Care Facilities Code. replaced with
newer version.
1-154........... 1-181 ASME PVHO-1-2023 Withdrawn and
Safety Standard for replaced with
Pressure Vessels for newer version.
Human Occupancy.
1-75............ 1-182 ISO 5362 Fifth Withdrawn and
edition 2024-07 replaced with
Anaesthetic and newer version.
respiratory
equipment--Anaesthet
ic reservoir bags.
1-99............ 1-183 ASTM G175-24 Standard Withdrawn and
Test Method for replaced with
Evaluating the newer version.
Ignition Sensitivity
and Fault Tolerance
of Oxygen Pressure
Regulators Used for
Medical and
Emergency
Applications.
1-140........... 1-184 ISO 80601-2-55 Second Withdrawn and
edition 2018-02 replaced with
[Including newer version.
AMD1:2023] Medical
electrical
equipment--Part 2-
55: Particular
requirements for the
basic safety and
essential
performance of
respiratory gas
monitor [Including
Amendment 1 (2023)].
1-143........... 1-185 ISO 80601-2-79 Second Withdrawn and
edition 2024-08 replaced with
Medical electrical newer version.
equipment--Part 2-
79: Particular
requirements for
basic safety and
essential
performance of
ventilatory support
equipment for
ventilatory
impairment.
1-144........... 1-186 ISO 80601-2-80 Second Withdrawn and
edition 2024-08 replaced with
Medical electrical newer version.
equipment--Part 2-
80: Particular
requirements for
basic safety and
essential.
1-146........... 1-187 ISO 80601-2-12 Third Withdrawn and
edition 2023-11 replaced with
Medical electrical newer version.
equipment--Part 2-
12: Particular
requirements for
basic safety and
essential
performance of
critical care
ventilators.
1-160........... 1-188 ISO 80601-2-84 Second Withdrawn and
edition 2023-11 replaced with
Medical electrical newer version.
equipment--Part 2-
84: Particular
requirements for the
basic safety and
essential
performance of
ventilators for the
emergency medical
services environment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-266........... 2-304 ASTM F2382-24 Withdrawn and
Standard Test Method replaced with
for Assessment of newer version.
Circulating Blood-
Contacting Medical
Device Materials on
Partial
Thromboplastin Time
(PTT).
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-54............ .............. ANSI AAMI ISO Transferred.
7198:2016 See 3-144.
Cardiovascular
implants and
extracorporeal
systems--Vascular
prostheses--Tubular
vascular grafts and
vascular patches.
3-143........... 3-193 ISO 12417-1 Second Withdrawn and
edition 2024-02 replaced with
Cardiovascular newer version.
implants and Extent of
extracorporeal recognition.
systems--Vascular
device-drug
combination
products--Part 1:
General requirements.
3-150........... 3-194 ISO 7199 Fourth Withdrawn and
edition 2024-09 replaced with
Cardiovascular newer version.
implants and
artificial organs--
Blood-gas exchangers
(oxygenators).
3-157........... .............. ANSI AAMI ISO 25539- Transferred.
1:2017 See 3-149.
Cardiovascular
implants--Endovascul
ar devices--Part 1:
Endovascular
prostheses.
3-159........... 3-195 ISO 5910 Second Withdrawn and
edition 2024-07 replaced with
Cardiovascular newer version.
implants and
extracorporeal
systems--Cardiac
valve repair devices.
3-166........... 3-196 ISO 81060-2 Third Withdrawn and
edition 2018-11 replaced with
[Including AMD1:2020 newer version.
and AMD2:2024] Non- Extent of
invasive recognition.
sphygmomanometers--P
art 2: Clinical
investigation of
intermittent
automated
measurement type
[Including:
AMENDMENT 1 (2020)
and AMENDMENT 2
(2024)].
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-97............ 4-328 ANSI/ADA Standard No. Withdrawn and
57-2021 Endodontic replaced with
Sealing Materials. newer version.
[[Page 13170]]
4-149........... .............. ANSI/ADA Standard No. Withdrawn. See
39-2006 (R2011) Pit 4-222.
and Fissure Sealants.
4-251........... 4-329 ISO 6872 Fifth Withdrawn and
edition 2024-08 replaced with
Dentistry--Ceramic newer version.
materials.
4-272........... 4-330 ANSI/ADA Standard No. Withdrawn and
63-2020 Endodontic replaced with
Instruments--Auxilla newer version.
ry.
4-291........... 4-331 ISO 28399 Third Withdrawn and
Edition 2021-03 replaced with
Dentistry--External newer version.
tooth bleaching
products.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-10........... 19-51 UL 1642 Sixth Edition Withdrawn and
September 29, 2020 replaced with
Standard For Safety newer version.
Lithium Batteries.
19-11........... 19-52 UL 2054 Third Edition Withdrawn and
November 17, 2021 replaced with
Standard For Safety newer version.
Household and
Commercial Batteries.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-406........... 6-504 ASTM F1862/F1862M-24 Withdrawn and
Standard Test Method replaced with
for Resistance of newer version.
Medical Face Masks
to Penetration by
Synthetic Blood
(Horizontal
Projection of Fixed
Volume at a Known
Velocity).
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-189........... 7-322 CLSI M47 2nd Edition; Withdrawn and
Principles and replaced with
Procedures for Blood newer version.
Cultures.
7-266........... 7-323 CLSI EP19 3rd Edition Withdrawn and
A Framework for replaced with
Using CLSI Documents newer version.
to Evaluate Clinical
Laboratory
Measurement
Procedures.
7-279........... 7-324 CLSI M07 12th Edition Withdrawn and
Methods for Dilution replaced with
Antimicrobial newer version.
Susceptibility Tests
for Bacteria That
Grow Aerobically.
7-280........... 7-325 CLSI M02 14th Edition Withdrawn and
Performance replaced with
Standards for newer version.
Antimicrobial Disk
Susceptibility Tests.
7-292........... 7-326 CLSI M24S 2nd Edition Withdrawn and
Performance replaced with
Standards for newer version.
Susceptibility
Testing of
Mycobacteria,
Nocardia spp., and
Other Aerobic
Actinomycetes.
7-317........... 7-327 CLSI M100 34th Withdrawn and
Edition Performance replaced with
Standards for newer version.
Antimicrobial
Susceptibility
Testing.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-393........... 8-618 ASTM F1350-24 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought 18 Chromium-
14 Nickel-2.5
Molybdenum Stainless
Steel Surgical
Fixation Wire (UNS
S31673).
8-405........... 8-619 ISO 5832-4 Fourth Withdrawn and
edition 2024-04 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 4:
Cobalt-chromium-
molybdenum casting
alloy.
8-406........... 8-620 ISO 5832-11 Third Withdrawn and
edition 2024-03 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 11:
Wrought titanium 6-
aluminium 7-niobium
alloy.
8-435........... 8-621 ISO 5832-1 Sixth Withdrawn and
edition 2024-04 replaced with
Implants for newer version.
surgery--Metallic
materials--Part 1:
Wrought stainless
steel.
8-476........... 8-622 ASTM F2004-24 Withdrawn and
Standard Test Method replaced with
for Transformation newer version.
Temperature of
Nickel-Titanium
Alloys by Thermal
Analysis.
8-481........... 8-623 ASTM F1314-24 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Nitrogen
Strengthened
22Chromium-13Nickel-
5Manganese-
2.5Molybdenum
Stainless Steel
Alloy Bar and Wire
for Surgical
Implants (UNS
S20910).
8-522........... 8-624 ASTM F2129-24 Withdrawn and
Standard Test Method replaced with
for Conducting newer version.
Cyclic
Potentiodynamic
Polarization
Measurements to
Determine the
Corrosion
Susceptibility of
Small Implant
Devices.
------------------------------------------------------------------------
8-599........... 8-625 ASTM F1295-24 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Titanium-6
Aluminum-7Niobium
Alloy for Surgical
Implant Applications
(UNS R56700).
------------------------------------------------------------------------
[[Page 13171]]
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-254.......... .............. ISO 14630 Fourth Withdrawn with
edition 2012-12-01 transition.
Non-active surgical See 5-143.
implants--General
requirements.
------------------------------------------------------------------------
11-308.......... 11-410 ASTM F3161-24 Withdrawn and
Standard Test Method replaced with
for Finite Element newer version.
Analysis (FEA) of
Metallic Orthopaedic
Total Knee Femoral
Components under
Closing Conditions.
11-310.......... 11-411 ASTM F1611-20 Withdrawn and
(Reapproved 2024) replaced with
Standard newer version.
Specification for
Intramedullary
Reamers.
11-317.......... 11-412 ASTM F3129-24 Withdrawn and
Standard Guide for replaced with
Characterization of newer version.
Material Loss from
Conical Taper
Junctions in Total
Joint Prostheses.
11-327.......... 11-413 ASTM F543-23 Standard Withdrawn and
Specification and replaced with
Test Methods for newer version.
Metallic Medical
Bone Screws.
11-333.......... 11-414 ASTM F382-24 Standard Withdrawn and
Specification and replaced with
Test Method for newer version.
Metallic Bone Plates.
11-350.......... 11-415 ASTM F2554-22 Withdrawn and
Standard Practice replaced with
for Measurement of newer version.
Positional Accuracy
of Computer-Assisted
Surgical Systems.
11-372.......... 11-416 ASTM F2996-24 Withdrawn and
Standard Test Method replaced with
for Finite Element newer version.
Analysis (FEA) of
Non-Modular Metallic
Orthopaedic Hip
Femoral Stems.
11-382.......... 11-417 ASTM F3090-24 Withdrawn and
Standard Test Method replaced with
for Fatigue Testing newer version.
of Acetabular
Devices for Total
Hip Replacement and
Performance
Requirements.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-259.......... 12-362 IEC 61674 Edition 3.0 Withdrawn and
2024-07 Medical replaced with
electrical newer version.
equipment--Dosimeter
s with ionization
chambers and/or
semiconductor
detectors as used in
X-ray diagnostic
imaging.
12-352.......... 12-363 NEMA PS 3.1-3.20 Withdrawn and
2024e Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM) set.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-116.......... 13-140 FIRST CVSS v4.0 Withdrawn and
Common Vulnerability replaced with
Scoring System newer version.
version 4.0.
13-18........... .............. CLSI LIS03-A Standard Withdrawn.
Guide for Selection
of a Clinical
Laboratory
Information
Management System.
13-19........... .............. CLSI LIS04-A Standard Withdrawn.
Guide for
Documentation of
Clinical Laboratory
Computer Systems.
13-20........... .............. CLSI LIS05-A Standard Withdrawn.
Specification for
Transferring
Clinical
Observations Between
Independent Computer
Systems.
13-21........... .............. CLSI LIS06-A Standard Withdrawn.
Practice for
Reporting
Reliability of
Clinical Laboratory
Information Systems.
13-22........... .............. CLSI LIS07-A Standard Withdrawn.
Specification for
Use of Bar Codes on
Specimen Tubes in
the Clinical
Laboratory.
13-23........... .............. CLSI LIS08-A Standard Withdrawn.
Guide for Functional
Requirements of
Clinical Laboratory
Information
Management Systems.
13-24........... .............. CLSI LIS09-A Standard Withdrawn.
Guide for
Coordination of
Clinical Laboratory
Services within the
Electronic Health
Record Environment
and Networked
Architectures.
------------------------------------------------------------------------
[[Page 13172]]
R. Sterility
------------------------------------------------------------------------
14-290.......... 14-606 ANSI/AAMI ST24:2024 Withdrawn and
General-purpose replaced with
ethylene oxide newer version.
sterilizers with
automated process
control and ethylene
oxide sterilant
sources intended for
use in health care
facilities.
14-432.......... 14-607 ANSI/AAMI ST58:2024 Withdrawn and
Chemical replaced with
sterilization and newer version.
high-level
disinfection in
health care
facilities.
14-460.......... .............. ISO 11140-1 Third Extent of
edition 2014-11-01 Recognition.
Sterilization of
health care
products--Chemical
indicators--Part 1:
General requirements.
14-588.......... 14-609 AAMI TIR17:2024 Withdrawn and
Compatibility of replaced with
materials subjected newer version.
to sterilization.
------------------------------------------------------------------------
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: 063. 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
------------------------------------------------------------------------
1-189.................... Anaesthetic and ISO 4135 Fourth
respiratory equipment-- edition 2022-01.
Vocabulary.
1-190.................... Anaesthetic and ISO 9360-1 First
respiratory equipment-- edition 2000-03.
Heat and moisture
exchangers (HMEs) for
humidifying respired
gases in humans--Part
1: HMEs for use with
minimum tidal volumes
of 250 ml.
1-191.................... Anaesthetic and ISO 9360-2 First
respiratory equipment-- edition 2001-04.
Heat and moisture
exchangers (HMEs) for
humidifying respired
gases in humans--Part
2: HMEs for use with
tracheostomized
patients having minimum
tidal volumes of 250 ml.
1-192.................... Anaesthetic and ISO 23371 First
respiratory equipment-- edition 2022-05.
Cuff pressure
indication, control and
regulation devices.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-197.................... Cardiovascular implants-- ISO 25539-4 First
Endovascular devices-- edition 2021-11.
Part 4: Application of
ISO 17327-1 for coated
endovascular devices.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-332.................... Implantable Materials ANSI/ADA Standard
for Bone Filling and No. 206-2024.
Augmentation in Oral
and Maxillofacial
Surgery--Contents of a
Technical File.
4-333.................... Dentistry--Endodontic ISO 3630-4 Second
instruments--Part 4: edition 2023-08.
Auxiliary instruments.
4-334.................... Dentistry--Amalgam ISO 11143 Second
separators. edition 2008-07.
4-335.................... Dentistry--Single-use ISO 11499 Third
cartridges for local edition 2014-06.
anaesthetics.
4-336.................... Dentistry--Powered ISO 18397 First
scaler. edition 2016-01.
4-337.................... Dentistry--Powder jet ISO 20608 First
handpieces and powders. edition 2018-04.
4-338.................... Dentistry--Rotational ISO 22683 First
adaptability test edition 2022-05.
between implant body
and implant abutment in
dental implant systems.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
5-143.................... Non-active surgical ISO 14630 Fifth
implants--General edition 2024-09.
requirements.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
19-53.................... Medical electrical IEC TS 60601-4-6
equipment--Part 4-6: Edition 1.0 2024-
Guidance and 04.
interpretation--Volunta
ry guidance to help
achieve basic safety
and essential
performance with regard
to the possible effects
of electromagnetic
disturbances.
------------------------------------------------------------------------
[[Page 13173]]
G. GH/GPS
------------------------------------------------------------------------
6-503.................... Systems for evacuation ISO 16571 Second
of plume generated by edition 2024-03.
medical device.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-626.................... Standard Test Method for ASTM E2948-24.
Conducting Rotating
Bending Fatigue Tests
of Solid Round Fine
Wire.
8-627.................... Standard Practice for ASTM F3604-23.
Validating the Additive
Manufacturing (AM)
Production Process for
Medical Devices
Produced Using Laser
Powder Bed Fusion.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/Gastro/Urology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-418................... Standard Test Method for ASTM F3631-24.
Assessment of Intra-
operative Durability of
Intervertebral Body
Fusion Devices.
------------------------------------------------------------------------
11-419................... Standard Test Method for ASTM F3690-24.
Evaluating Suture
Anchor Insertion and
Pull Displacement
Resistance.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-364 Evaluation and routine IEC 61223-3-8
testing in medical Edition 1.0 2024-
imaging departments-- 03.
Part 3-8: Acceptance
and constancy tests--
Imaging performance of
X-ray equipment for
radiography and
radioscopy.
12-365................... Diagnostic X-ray imaging IEC 60627 Edition
equipment--Characterist 3.0 2013-07.
ics of general purpose
and mammographic anti-
scatter grids.
12-366................... Evaluation and routine IEC 61223-3-6
testing in medical Edition 1.0 2020-
imaging departments-- 02.
Part 3-6: Acceptance
and constancy tests--
Imaging performance of
mammographic X-ray
equipment used in a
mammographic
tomosynthesis mode of
operation.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-141................... Health informatics-- ISO/IEEE 11073-
Device interoperability 10701 First
Part 10701: Point-of- Edition 2024-09.
care medical device
communication--Metric
provisioning by
participants in a
Service-oriented Device
Connectivity (SDC)
system.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-604................... Sterilization of health ISO 11737-3 First
care products-- edition 2023-06.
Microbiological
methods--Part 3:
Bacterial endotoxin
testing.
14-605................... Sterilization of health ISO 13004 First
care products-- edition 2022-10.
Radiation--Substantiati
on of selected
sterilization dose:
Method VDmaxSD.
14-608................... Microbiological methods-- AAMI TIR106:2024.
Understanding and use
of product bioburden
data.
------------------------------------------------------------------------
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 13174]]
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: March 13, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04711 Filed 3-19-25; 8:45 am]
BILLING CODE 4164-01-P