[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Notices]
[Pages 15202-15208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04376]
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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: 061
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 061'' (Recognition List Number: 061), 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 March 1, 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
[[Page 15203]]
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: 061.'' 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: 061.
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: 061 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:
061 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: 061'' 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/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 061
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: 061'' 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
[[Page 15204]]
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: 061.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
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A. Anesthesiology
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1-73............. 1-162 ISO 10651-4 Second Withdrawn and
edition 2023-03 Lung replaced with
ventilators--Part 4: newer version.
Particular
requirements for
user-powered
resuscitators.
1-105............ 1-163 ISO 80601-2-72 Second Withdrawn and
edition 2023-06 replaced with
Medical electrical newer version.
equipment--Part 2-
72: Particular
requirements for
basic safety and
essential
performance of home
healthcare
environment
ventilators for
ventilator-dependent
patients.
1-118............ 1-164 ISO 5361 Fourth Withdrawn and
edition 2023-11 replaced with
Anaesthetic and newer version.
respiratory
equipment--Tracheal
tubes and connectors.
1-141............ 1-165 ISO 80601-2-13 Second Withdrawn and
edition 2022-04 replaced with
Medical electrical newer version.
equipment--Part 2-
13: Particular
requirements for
basic safety and
essential
performance of an
anaesthetic
workstation.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-94............. 2-302 ASTM F981-23 Standard Withdrawn and
Practice for replaced with
Assessment of Muscle newer version.
and Bone Tissue
Responses to Long-
Term Implantable
Materials Used in
Medical Devices.
2-237............ 2-303 ISO 10993-17 Second Withdrawn and
edition 2023-09 replaced with
Biological newer version.
evaluation of
medical devices--
Part 17:
Toxicological risk
assessment of
medical device
constituents.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-105............ ............ IEC 60601-2-25 Extent of
Edition 2.0 2011-10 recognition.
Medical electrical
equipment--Part 2-
25: Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs.
3-126............ ............ IEC 60601-2-27 Extent of
Edition 3.0 2011-03 recognition.
Medical electrical
equipment--Part 2-
27: Particular
requirements for the
basic safety and
essential
performance of
electrocardiographic
monitoring equipment
[Including:
Corrigendum 1
(2012)].
3-138............ 3-189 ASTM F2942-19 Withdrawn and
Standard Guide for replaced with
in vitro Axial, newer version.
Bending, and
Torsional Durability
Testing of Vascular
Stents.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-137............ 4-309 ISO 6877 Third Withdrawn and
edition 2021-09 replaced with
Dentistry--Endodonti newer version.
c obturating
materials.
4-151............ 4-310 ISO 22112 Second Withdrawn and
edition 2017-08 replaced with
Dentistry--Artificia newer version.
l teeth for dental
prostheses.
4-188............ 4-311 ISO 9917-2 Third Withdrawn and
edition 2017-09 replaced with
Dentistry--Water- newer version.
based cements--Part
2: Resin-modified
cements.
4-190............ 4-312 ANSI/ASA S3.35-2021 Withdrawn and
American National replaced with
Standard Method for newer version.
Method of
Measurement of
Performance
Characteristics of
Hearing Aids Under
Simulated Real-Ear
Working Conditions.
4-218............ 4-313 ISO 27020 Second Withdrawn and
edition 2019-06 replaced with
Dentistry--Brackets newer version.
and tubes for use in
orthodontics.
4-221............ 4-314 ISO 7494-2 Third Withdrawn and
edition 2022-07 replaced with
Dentistry--Stationar newer version.
y dental units and
dental patient
chairs--Part 2: Air,
water, suction and
wastewater systems.
4-224............ 4-315 ISO 24234 Third Withdrawn and
edition 2021-08 replaced with
Dentistry--Dental newer version.
Amalgam.
4-238............ 4-316 ISO 20127 Second Withdrawn and
edition 2020-08 replaced with
Dentistry--Physical newer version.
properties of
powered toothbrushes.
4-244............ 4-317 ISO 8325 Third Withdrawn and
edition 2023-03 replaced with
Dentistry--Test newer version.
methods for rotary
instruments.
4-246............ 4-318 ISO 20749 Second Withdrawn and
edition 2023-06 replaced with
Dentistry--Pre- newer version.
capsulated dental
amalgam.
4-257............ 4-319 ISO 17730 Second Withdrawn and
edition 2020-09 replaced with
Dentistry--Fluoride newer version.
varnishes.
4-280............ ............ ANSI/ADA Standard No. Withdrawn with
117-2018 Fluoride transition. See
varnishes. 4-319.
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[[Page 15205]]
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-338............ 6-497 ASTM D7866-23 Withdrawn and
Standard replaced with
Specification for newer version.
Radiation
Attenuating
Protective Gloves.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-235............ 7-318 CLSI EP25 2nd Edition Withdrawn and
Evaluation of replaced with
Stability of In newer version.
Vitro Medical
Laboratory Test
Reagents.
7-304............ 7-319 CLSI M23 6th Edition Withdrawn and
Development of In replaced with
Vitro Susceptibility newer version.
Test Methods,
Breakpoints, and
Quality Control
Parameters.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-171............ 8-605 ASTM F1609-23 Withdrawn and
Standard replaced with
Specification for newer version.
Calcium Phosphate
Coatings for
Implantable
Materials.
8-412............ 8-606 ASTM F2537-23 Withdrawn and
Standard Practice replaced with
for Calibration of newer version.
Linear Displacement
Sensor Systems Used
to Measure
Micromotion.
8-437............ 8-607 ASTM F2082/F2082M-23 Withdrawn and
Determination of replaced with
Transformation newer version.
Temperature of
Nickel-Titanium
Shape Memory Alloys
by Bend and Free
Recovery.
8-451............ 8-608 ASTM F2214-2023 Withdrawn and
Standard Test Method replaced with
for In Situ newer version.
Determination of
Network Parameters
of Crosslinked Ultra
High Molecular
Weight Polyethylene
(UHMWPE).
8-475............ 8-609 ASTM F2026-23 Withdrawn and
Standard replaced with
Specification for newer version.
Polyetheretherketone
(PEEK) Polymers for
Surgical Implant
Applications.
8-483............ 8-610 ASTM F601-23 Standard Withdrawn and
Practice for replaced with
Fluorescent newer version.
Penetrant Inspection
of Metallic Surgical
Implants.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
11-83............ ............ ISO 13402 First Transferred. See
edition 1995-08-01 4-320.
Surgical and dental
hand instruments--
Determination of
resistance against
autoclaving,
corrosion and
thermal exposure.
11-276........... 11-402 ASTM F1798-21 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.
11-281........... ............ ASTM F1672-14 Withdrawn with
(Reapproved 2019) transition. See
Standard 11-400.
Specification for
Resurfacing Patellar
Prosthesis.
11-299........... ............ ASTM F2068-15 Withdrawn with
Standard transition. See
Specification for 11-401.
Femoral Prostheses--
Metallic Implants.
11-301........... ............ ASTM F2091-15 Withdrawn with
Standard transition. See
Specification for 11-401.
Acetabular
Prostheses.
11-303........... 11-403 ASTM F3047M-23 Withdrawn and
Standard Guide for replaced with
High Demand Hip newer version.
Simulator Wear
Testing of Hard-on-
Hard Articulations.
11-321........... 11-404 ASTM F2887-23 Withdrawn and
Standard replaced with
Specification for newer version.
Total Elbow
Prostheses.
[[Page 15206]]
11-334........... 11-405 ASTM F1829-23 Withdrawn and
Standard Test Method replaced with
for Static newer version.
Evaluation of
Anatomic Glenoid
Locking Mechanism in
Shear.
11-335........... 11-406 ASTM F3141-23 Withdrawn and
Standard Guide for replaced with
Total Knee newer version.
Replacement Loading
Profiles.
11-341........... 11-407 ASTM F3140-23 Withdrawn and
Standard Test Method replaced with
for Cyclic Fatigue newer version.
Testing of Metal
Tibial Tray
Components of
Unicondylar Knee
Joint Replacements.
11-377........... ............ ASTM F2083-21 Withdrawn with
Standard transition. See
Specification for 11-400.
Knee Replacement
Prosthesis.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-348........... ............ IEC 60601-2-54 Extent of
Edition 2.0 2022-09 recognition.
Medical electrical
equipment--Part 2-
54: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
radiography and
radioscopy.
12-349........... 12-352 NEMA PS 3.1-3.20 Withdrawn and
2023e Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM) set.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-141........... 14-589 ISO 14644-4 Second Withdrawn and
edition 2022-11 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
4: Design,
construction and
start-up.
14-379........... 14-590 ISO 14644-8 Third Withdrawn and
edition 2022-06 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
8: Assessment of air
cleanliness by
chemical
concentration (ACC).
14-390........... 14-591 ISO 14644-10 Second Withdrawn and
edition 2022-05 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
10: Assessment of
surface cleanliness
for chemical
contamination.
14-427........... 14-592 ISO 13408-1 Third Withdrawn and
edition 2023-08 replaced with
Aseptic processing newer version.
of health care
products--Part 1:
General requirements.
14-516........... 14-593 ASTM F3039-23 Withdrawn and
Standard Test Method replaced with
for Detecting Leaks newer version.
in Nonporous
Packaging or
Flexible Barrier
Materials by Dye
Penetration.
14-530........... 14-594 ISO 11607-1 Second Withdrawn and
edition 2019-02 replaced with
[Including newer version.
ADM1:2023] Packaging
for terminally
sterilized medical
devices--Part 1:
Requirements for
materials, sterile
barrier systems and
packaging systems
[Including Amendment
1 (2023)].
14-531........... 14-595 ISO 11607-2 Second Withdrawn and
edition 2019-02 replaced with
[Including newer version.
AMD1:2023] Packaging
for terminally
sterilized medical
devices--Part 2:
Validation
requirements for
forming, sealing and
assembly processes
[Including Amendment
1 (2023)].
14-573........... 14-596 ASTM F88/F88M-23 Withdrawn and
Standard Test Method replaced with
for Seal Strength of newer version.
Flexible Barrier
Materials.
------------------------------------------------------------------------
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: 061. 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
------------------------------------------------------------------------
1-166.................... Gas mixers for medical ISO 11195 Second
use--Stand-alone gas edition 2018-01.
mixers..
------------------------------------------------------------------------
[[Page 15207]]
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-190.................... Sizing parameters of ISO/PAS 7020 First
surgical valve edition 2023-05.
prostheses:
Requirements regarding
the application of ISO
5840-2.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-320.................... Surgical and dental and ISO 13402 First
instruments--Determinat edition 1995-08.
ion of resistance
against autoclaving,
corrosion and thermal
exposure.
4-321.................... Dentistry--Intraoral ISO 23450 First
camera. edition 2021-03.
4-322.................... Dentistry--Machinable ISO 18675 First
ceramic blanks. edition 2022-05.
4-323.................... Dentistry--Polymer-based ISO 5139 First
composite machinable edition 2023-05.
blanks.
4-324.................... Dentistry--Polymer-based ISO/TS 16506 First
luting materials edition 2018-03.
containing adhesive
components.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
7-320.................... Validation of Assays CLSI H62 1st
Performed by Flow Edition.
Cytometry.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-24.................... Standard Test Method for ASTM E2524-22.
Analysis of Hemolytic
Properties of
Nanoparticles.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-150.................... Copper-bearing ISO 7439 Fourth
contraceptive edition 2023-04.
intrauterine devices--
Requirements and tests.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. OrthopedicX
------------------------------------------------------------------------
11-400................... Non-active surgical ISO 21536 Third
implants--Joint edition 2023-07.
replacement implants--
Specific requirements
for knee-joint
replacement implants.
11-401................... Non-active surgical ISO 21535 Third
implants--Joint edition 2023-07.
replacement implants--
Specific requirements
for hip-joint
replacement implants.
11-408................... Standard Test Method for ASTM F2777-23.
Evaluating Knee Bearing
(Tibial Insert)
Endurance and
Deformation Under High
Flexion.
11-409................... Standard Test Methods ASTM F3495-23.
for Determining the
Static Failure Load of
Ceramic Knee Femoral
Components.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-353................... American National ANSI Z136.1-2022.
Standard for Safe Use
of Lasers.
------------------------------------------------------------------------
[[Page 15208]]
Q. Software/Informatics
------------------------------------------------------------------------
13-129................... Software and systems ISO/IEC/IEEE 29119-
engineering--Software 1 Second edition
testing--Part 1: 2022-01.
General concepts.
13-130................... Medical devices and ANSI/AAMI 2700-2-
medical systems-- 1:2022.
Essential safety and
performance
requirements for
equipment comprising
the patient-centric
integrated clinical
environment (ICE): Part
2-1: Particular
requirements for
forensic data logging.
13-131................... Standard for medical ANSI/AAMI
device security-- SW96:2023.
Security risk
management for device
manufacturers.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-597................... Water Quality for ANSI/AAMI
Processing Medical ST108:2023.
Devices.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: February 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04376 Filed 2-29-24; 8:45 am]
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