[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52473-52479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13777]
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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: 062
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: 062'' (Recognition List Number: 062), 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 24, 2024.
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: 062.'' 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: 062.
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
[[Page 52474]]
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: 062 is available on
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA-recognized consensus standards, including Recognition List Number:
062 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: 062'' 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 Division of Standards and
Conformity Assessment is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 062
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: 062'' 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: 062.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-81............. 1-167 CGA V-5:2019 Standard Withdrawn and
for Diameter Index replaced with
Safety System newer version.
(Noninterchangeable
Low Pressure
Connections for
Medical Gas
Applications).
1-97............. 1-168 CGA V-7.1:2021 Withdrawn and
Standard Method of replaced with
Determining Cylinder newer version.
Valve Outlet
Connections for
Medical Gases.
1-100............ 1-169 CGA V-1:2021 Standard Withdrawn and
for Compressed Gas replaced with
Cylinder Valve newer version.
Outlet and Inlet
Connections.
1-101............ 1-170 CGA C-9:2019 Standard Withdrawn and
Color Marking of replaced with
Compressed Gas newer version.
Containers for
Medical Use.
1-103............ 1-171 ISO 5367 Sixth Extent of
edition 2023-07 recognition.
Anaesthetic and Withdrawn and
respiratory replaced with
equipment--Breathing newer version.
sets and connectors.
1-126............ 1-172 ISO 11712 Second Withdrawn and
edition 2023-11 replaced with
Anaesthetic and newer version.
respiratory
equipment--Supralary
ngeal airways and
connectors.
1-134............ 1-173 ISO 18562-1 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
1: Evaluation and
testing within a
risk management
process.
[[Page 52475]]
1-135............ 1-174 ISO 18562-2 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
2: Tests for
emissions of
particulate matter.
1-136............ 1-175 ISO 18562-3 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
3: Tests for
emissions of
volatile organic
substances.
1-137............ 1-176 ISO 18562-4 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
4: Tests for
leachables in
condensate.
1-138............ 1-177 ISO 80601-2-74 Second Withdrawn and
edition 2021-07 replaced with
Medical electrical newer version.
equipment--Part 2-
74: Particular
requirements for
basic safety and
essential
performance of
respiratory
humidifying
equipment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-163............ 3-191 ISO 18242 First Withdrawn and
edition 2016-09-01 replaced with
[Including newer version.
AMD1:2023]
Cardiovascular
implants and
extracorporeal
systems--Centrifugal
blood pumps
[Including AMENDMENT
1 (2023)].
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-215............ 4-325 ANSI/ADA Standard No. Withdrawn and
96-2020 Dental Water- replaced with
based Cements. newer version.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-19............ 19-50 IEC TS 60601-4-2 Withdrawn and
Edition 1.0 2024-03 replaced with
Medical electrical newer version.
equipment--Part 4-2:
Guidance and
interpretation--Elec
tromagnetic
immunity:
performance of
medical electrical
equipment and
medical electrical
systems.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-295............ ............ ANSI AAMI BF7:2012 Withdrawn.
Blood transfusion
microfilters.
6-322............ 6-498 ISO 10555-4 Third Withdrawn and
edition 2023-11 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 4:
Balloon dilatation
catheters.
6-408............ 6-499 ISO 10555-1 Third Withdrawn and
edition 2023-11 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 1:
General requirements.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-159............ 8-611 ISO 9584 Second Withdrawn and
edition 2023-10 replaced with
Implants for newer version.
surgery--Nondestruct
ive testing--
Radiographic
examination of cast
metallic surgical
implants.
8-527............ 8-612 ASTM F899-23 Standard Withdrawn and
Specification for replaced with
Wrought Stainless newer version.
Steels for Surgical
Instruments.
8-580............ ............ IEC 63145-20-10 Transferred. See
Edition 1.0 2019-08 12-357.
Eyewear display--
Part 20-10:
Fundamental
measurement methods--
Optical properties.
8-581............ ............ IEC 63145-20-20 Transferred. See
Edition 1.0 2019-09 12-358.
Eyewear display--
Part 20-20:
Fundamental
measurement methods--
Image quality.
8-582............ ............ IEC 63145-22-10 Transferred. See
Edition 1.0 2020-01 12-359.
Eyewear display--
Part 22-10: Specific
measurement methods
for AR type--Optical
properties.
------------------------------------------------------------------------
[[Page 52476]]
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-13............ 17-18 IEEE Std 2010-2023 Withdrawn and
Recommended Practice replaced with
for newer version.
Electroencephalograp
hy (EEG)
Neurofeedback
Systems.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-56............ ............ ANSI Z80.12-2007 Withdrawn with
(R2022) American transition. See
National Standard 10-135.
for Ophthalmics--
Multifocal
Intraocular Lenses.
10-70............ 10-134 ISO 10943 Fourth Withdrawn and
edition 2023-01-- replaced with
ophthalmic newer version.
instruments--Indirec
t ophthalmoscopes.
10-125........... 10-135 ISO 11979-7 Fifth Withdrawn and
edition 2024-01 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 7: Clinical
investigations of
intraocular lenses
that are implanted
in the eye in order
to correct aphakia.
10-126........... 10-136 IEC 80601-2-58 Withdrawn and
Edition 3.0 2024-03 replaced with
Medical electrical newer version.
equipment--Part 2-
58: Particular
requirements for
basic safety and
essential
performance of lens
removal devices and
vitrectomy devices
for ophthalmic
surgery.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-232........... 12-354 NEMA MS 4-2023 Withdrawn and
Acoustic Noise replaced with
Measurement newer version.
Procedure for
Magnetic Resonance
Equipment.
12-242........... 12-355 IEC 60601-2-57 Withdrawn and
Edition 2.0 2023-07 replaced with
Medical Electrical newer version.
Equipment--Part 2-
57: Particular
requirements for the
basic safety and
essential
performance of non-
laser light source
equipment intended
for therapeutic,
diagnostic,
monitoring, cosmetic
and aesthetic use.
12-268........... 12-356 IEC 60601-2-22 Withdrawn and
Edition 4.0 2019-11 replaced with
Medical electrical newer version.
equipment--Part 2-
22: Particular
requirements for
basic safety and
essential
performance of
surgical, cosmetic,
therapeutic and
diagnostic laser
equipment.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-52............ 13-132 ISO/IEEE 11073-10408 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Point-
of-care medical
device
communication--Part
10408: Device
specialization--Ther
mometer.
13-53............ 13-133 ISO/IEEE 11073-10415 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Point-
of-care medical
device
communication--Part
10415: Device
specialization-
Weighing scale.
13-54............ 13-134 ISO/IEEE 11073-10404 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
10404: Device
specialization--Puls
e oximeter.
13-57............ 13-135 ISO/IEEE 11073-10407 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
10407: Device
Specialization--Bloo
d pressure monitor.
13-113........... 13-136 ISO/IEEE 11073-20601 Withdrawn and
Third Edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
20601: Application
profile--Optimized
exchange protocol.
13-114........... 13-137 IEEE Std 11073-10101b- Withdrawn and
2023 Health replaced with
informatics--Point- newer version.
of-care medical
device
communication--Part
10101: Nomenclature.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-242........... 14-598 ISO 14644-3 Second Withdrawn and
edition 2020-06 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
3: Test methods.
[[Page 52477]]
14-243........... ............ ISO 14644-6 First Withdrawn.
edition 2007-07
Cleanrooms and
associated
controlled
environments--Part
6: Vocabulary.
14-277........... ............ ISO TS 17665-2 First Withdrawn with
edition 2009-01 transition. See
Sterilization of 14-601.
health care
products--Moist
heat--Part 2:
Guidance on the
application of ISO
17665-1.
14-333........... ............ ISO 17665-1 First Withdrawn with
edition 2006-08 transition. See
Sterilization of 14-601.
health care
products--Moist
heat--Part 1:
Requirements for the
development,
validation and
routine control of a
sterilization
process for medical
devices.
14-389........... 14-599 ISO 14644-9 Second Withdrawn and
edition Cleanrooms replaced with
and associated newer version.
controlled
environments--Part
9: Assessment of
surface cleanliness
for particle
concentration.
14-484........... 14-600 ASTM F1929-23 Withdrawn and
Standard Test Method replaced with
for Detecting Seal newer version.
Leaks in Porous
Medical Packaging by
Dye Penetration.
------------------------------------------------------------------------
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: 062. 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
------------------------------------------------------------------------
1-178.................... Anaesthetic and ISO 23747 Second
respiratory equipment-- edition 2015-08.
Peak expiratory flow
meters for the
assessment of pulmonary
function in
spontaneously breathing
humans.
1-179.................... Anaesthetic and ISO 26782 First
respiratory equipment-- edition 2009-07.
Spirometers intended
for the measurement of
time forced expired
volumes in humans
[Including: Technical
Corrigendum 1 (2009)].
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-192.................... Cardiovascular implants-- ISO 22679 First
Transcatheter cardiac edition 2021-11.
occluders.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-326.................... Dentistry--Graphical ISO 9687 Second
symbols for dental edition 2015-02.
equipment [Including
AMENDMENT 1 (2018)].
4-327.................... Dentistry--Graphical ISO 21531 First
symbols for dental edition 2009-02.
instruments.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
5-142.................... Packaging--Distribution ISO 780 Fifth
packaging--Graphical edition 2015-12-
symbols for handling 01.
and storage of packages.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
6-500.................... Ultrasonics--Non- IEC 63045 Edition
focusing short pressure 1.0 2020-05.
pulse sources including
ballistic pressure
pulse sources--
Characteristics of
fields.
6-501.................... Plastic containers for ISO 15747 Third
intravenous injections. edition 2018-09.
6-502.................... Injection systems for ISO 23217 First
self-administration by edition 2024-02.
paediatric patients--
Requirements and
guidelines for design.
------------------------------------------------------------------------
[[Page 52478]]
H. IVD
------------------------------------------------------------------------
7-321.................... Molecular Methods for CLSI MM24 1st
Genotyping and Strain Edition.
Typing of Infectious
Organisms.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-613.................... Standard Specification ASTM F2527-24.
for Wrought Seamless
and Welded and Drawn
Cobalt Alloy Small
Diameter Tubing for
Surgical Implants.
8-614.................... Standard Guide for ASTM F3456-22.
Powder Reuse Schema in
Powder Bed Fusion
Processes for Medical
Applications for
Additive Manufacturing
Feedstock Materials.
8-615.................... Additive manufacturing ISO/ASTM 52926-1
of metals-- First edition 2023-
Qualification 11.
principles--Part 1:
General qualification
of operators.
8-616.................... Additive manufacturing ISO/ASTM 52926-2
of metals-- First edition 2023-
Qualification 11.
principles--Part 2:
Qualification of
operators for PBF-LB.
8-617.................... Additive manufacturing ISO/ASTM 52926-3
of metals-- First edition 2023-
Qualification 11.
principles--Part 3:
Qualification of
operators for PBF-EB.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-19.................... Medical electrical ISO 80601-2-85
equipment--Part 2-85: Edition 1.0 2021-
Particular requirements 03.
for the basic safety
and essential
performance of cerebral
tissue oximeter
equipment.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-357................... Eyewear display--Part 20- IEC 63145-20-10
10: Fundamental Edition 1.0 2019-
measurement methods-- 08.
Optical properties.
12-358................... Eyewear display--Part 20- IEC 63145-20-20
20: Fundamental Edition 1.0 2019-
measurement methods-- 09.
Image quality.
12-359................... Eyewear display--Part 22- IEC 63145-22-10
10: Specific Edition 1.0 2020-
measurement methods for 01.
AR type--Optical
properties.
12-360................... Eyewear display--Part IEC 63145-10
10: Specifications. Edition 1.0 2023-
09.
12-361................... Information Display ICDM IDMS Version
Measurements Standard. 1.2 May 2023.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-138................... Health Informatics-- IEEE Std 11073-
Device Interoperability 10700-2022.
Part 10700: Point-of-
Care Medical Device
Communication--Standard
for Base Requirements
for Participants in a
Service-Oriented Device
Connectivity (SDC)
System.
13-139................... Health informatics-- IEEE Std 11073-
Device 10206-2022.
interoperability--Part
10206: Personal health
device communication--
Abstract Content
Information Model.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-601................... Sterilization of health ISO 17665 First
care products--Moist edition 2024-03.
heat--Requirements for
the development,
validation and routine
control of a
sterilization process
for medical devices.
14-602................... Designing, testing, and AAMI TIR12:2020/
labeling medical (R)2023.
devices intended for
processing by health
care facilities: A
guide for device
manufacturers.
14-603................... Product adoption and AAMI TIR28:2016/
process equivalence for (R)2020.
ethylene oxide
sterilization.
------------------------------------------------------------------------
[[Page 52479]]
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13777 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P