[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52173-52179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16770]
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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: 060
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: 060'' (Recognition List Number: 060), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable August 7, 2023.
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
[[Page 52174]]
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: 060.'' 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: 060.
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: 060 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:
060 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: 060'' to Jianchao Zeng, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. 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: Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580,
[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: 060
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: 060'' 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: 060.
[[Page 52175]]
Table 1--Modifications to the List of Recognized Standards
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Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
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A. Anesthesiology
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1-127........... 1-161 ISO 16628 Second Withdrawn and
edition 2022-06 replaced with
Anaesthetic and newer version.
respiratory
equipment--Tracheobro
nchial tubes.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-213........... 2-299 ASTM F1904-23 Standard Withdrawn and
Guide for Testing the replaced with
Biological Responses newer version.
to Medical Device
Particulate Debris
and Degradation
Products in vivo.
2-222........... 2-300 ISO 10993-2 Third Withdrawn and
edition 2022-11 replaced with
Biological evaluation newer version.
of medical devices--
Part 2: Animal
welfare requirements.
2-227........... 2-301 ASTM F1983-23 Standard Withdrawn and
Practice for replaced with
Assessment of newer version.
Selected Tissue
Effects of Absorbable
Biomaterials for
Implant Applications.
------------------------------------------------------------------------
C. Cardiovascular
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3-87............ 3-184 ASTM F2477-23 Standard Withdrawn and
Test Methods for in replaced with
vitro Pulsatile newer version.
Durability Testing of
Vascular Stents and
Endovascular
Prostheses.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-86............ ............ ANSI/ADA Standard No. Withdrawn.
38-2000 (R2015) Metal-
Ceramic Dental
Restorative Systems.
4-139........... ............ ANSI/ADA Standard No. Withdrawn.
48-2004 (R2015)
Visible Light Curing
Units.
4-181........... 4-298 ISO 4049 Fifth edition Withdrawn and
2019-05 Dentistry-- replaced with
Polymer-based newer version.
restorative materials.
4-198........... 4-299 ISO 3107 Fifth edition Withdrawn and
2022-09 Dentistry-- replaced with
Zinc oxide-eugenol newer version.
cements and non-
eugenol zinc oxide
cements.
4-227........... 4-300 ISO 22674 Third Withdrawn and
edition 2022-08 replaced with
Dentistry--Metallic newer version.
materials for fixed
and removable
restorations and
appliances.
4-231........... ............ ISO/TS 11405 Third Withdrawn.
edition 2015-02-01
Dentistry--Testing of
adhesion to tooth
structure.
4-240........... 4-301 ISO 21563 Second Withdrawn and
edition 2021-08 replaced with
Dentistry--Hydrocollo newer version.
id impression
materials.
4-248........... 4-302 ISO 10477 Fourth Withdrawn and
edition 2020-10 replaced with
Dentistry--Polymer- newer version.
based crown and
veneering materials.
4-249........... ............ ANSI/ADA Standard No. Withdrawn.
19-2018 Elastometric
Impression Materials.
4-253........... ............ ANSI/ADA Standard No. Withdrawn. See 4-
27-2016 Polymer-based 298.
Restorative Materials.
4-264........... 4-303 ISO 9333 Third edition Withdrawn and
2022-08 Dentistry-- replaced with
Brazing materials. newer version.
4-267........... 4-304 ISO 21606 Second Withdrawn and
edition 2022-08 replaced with
Dentistry--Elastomeri newer version.
c auxiliaries for use
in orthodontics.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34........... ............ IEC 61010-1 Edition Recognition
3.1 2017-01 restored.
CONSOLIDATED VERSION
Safety requirements
for electrical
equipment for
measurement, control,
and laboratory use--
Part 1: General
requirements
[Including:
Corrigendum 1 (2019)].
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-253........... 6-486 ISO 10535 Third Withdrawn and
Edition 2021-10 replaced with
Assistive products-- newer version.
Hoists for the
transfer of persons--
Requirements and test
methods.
6-296........... 6-487 AAMI PB70:2022 Liquid Withdrawn and
barrier performance replaced with
and classification of newer version.
protective apparel
and drapes intended
for use in health
care facilities.
6-306........... 6-488 ASTM F1671/F1671M-22 Withdrawn and
Standard Test Method replaced with
for Resistance of newer version.
Materials Used in
Protective Clothing
to Penetration by
Blood-Borne Pathogens
Using Phi-X174
Bacteriophage
Penetration as a Test
System.
6-321........... 6-489 IEC 60601-2-52 Edition Withdrawn and
1.1 2015-03 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-52:
Particular
requirements for the
basic safety and
essential performance
of medical beds.
6-357........... 6-490 ISO 10555-6 First Withdrawn and
edition 2015-04-15 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 6:
Subcutaneous
implanted ports
[Including Amendment
1 (2019)].
6-402........... 6-491 ASTM F1670/F1670M-17a Withdrawn and
Standard Test Method replaced with
for Resistance of newer version.
Materials Used in
Protective Clothing
to Penetration by
Synthetic Blood.
[[Page 52176]]
6-425........... 6-492 ASTM F2100-23 Standard Withdrawn and
Specification for replaced with
Performance of newer version.
Materials Used in
Medical Face Masks.
6-427........... 6-493 ASTM F2101-23 Standard Withdrawn and
Test Method for replaced with
Evaluating the newer version.
Bacterial Filtration
Efficiency (BFE) of
Medical Face Mask
Materials, Using a
Biological Aerosol of
Staphylococcus aureus.
6-474........... 6-494 ASTM F3352/F3352M-23a Withdrawn and
Standard replaced with
Specification for newer version.
Isolation Gowns
Intended for Use in
Healthcare Facilities.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-152........... 7-315 CLSI EP12 3rd Edition Withdrawn and
Evaluation of replaced with
Qualitative, Binary newer version.
Output Examination
Performance.
7-244........... 7-316 CLSI NBS01 7th Edition Withdrawn and
Dried Blood Spot replaced with
Specimen Collection newer version.
for Newborn Screening.
7-308........... 7-317 CLSI M100, 33rd Withdrawn and
Edition Performance replaced with
Standards for newer version.
Antimicrobial
Susceptibility
Testing.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-200........... 8-597 ASTM F2003-02(2022) Withdrawn and
Standard Practice for replaced with
Accelerated Aging of newer version.
Ultra-High Molecular
Weight Polyethylene
After Gamma
Irradiation in Air.
8-441........... 8-598 ASTM F3109-22 Standard Withdrawn and
Practice for replaced with
Verification of Multi- newer version.
Axis Force Measuring
Platforms.
8-453........... 8-599 ASTM F1295-22 Standard Withdrawn and
Specification for replaced with
Wrought Titanium- newer version.
6Aluminum-7Niobium
Alloy for Surgical
Implant Applications
(UNS R56700).
8-467........... 8-600 ASTM F1978-22 Standard Withdrawn and
Test Method for replaced with
Measuring Abrasion newer version.
Resistance of
Metallic Thermal
Spray Coatings by
Using the Taber
Abraser.
8-506........... 8-601 ASTM F2516-22 Standard Withdrawn and
Test Method for replaced with
Tension Testing of newer version.
Nickel-Titanium
Superelastic
Materials.
8-528........... 8-602 ASTM F2503-23 Standard Withdrawn and
Practice for Marking replaced with
Medical Devices and newer version.
Other Items for
Safety in the
Magnetic Resonance
Environment.
8-555........... 8-603 ASTM F1472-23 Standard Withdrawn and
Specification for replaced with
Wrought Titanium- newer version.
6Aluminum-4Vanadium
Alloy for Surgical
Implant Applications
(UNS R56400).
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-15........... 18-23 ASTM E3025-22 Standard Withdrawn and
Guide for Tiered replaced with
Approach to Detection newer version.
and Characterization
of Silver
Nanomaterials in
Textiles.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-67............ 9-145 ASTM D7661-18 Standard Withdrawn and
Test Method for replaced with
Determining newer version.
Compatibility of
Personal Lubricants
with Natural Rubber
Latex Condoms.
9-94............ 9-146 ISO 8600-4 Third Withdrawn and
Edition 2023-01 replaced with
Endoscopes--Medical newer version.
endoscopes and
endotherapy devices--
Part 4: Determination
of maximum width of
insertion portion.
9-125........... 9-147 ISO/CIE 11664-2 First Withdrawn and
edition 2022-08 replaced with
Colorimetry--Part 2: newer version.
CIE standard
illuminants.
9-128........... 9-148 ISO/CIE 11664-6 Second Withdrawn and
edition 2022-08 replaced with
Colorimetry--Part 6: newer version.
CIEDE2000 Colour-
difference formula.
9-143........... ............ ISO 20696 First Extent of
edition 2018-06 recognition.
Corrected version
2019-12 Sterile
urethral catheters
for single use.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-294.......... 11-399 ASTM F1357-23 Standard Withdrawn and
Specification for replaced with
Articulating Total newer version.
Wrist Implants.
------------------------------------------------------------------------
[[Page 52177]]
O. Physical Medicine
------------------------------------------------------------------------
16-165.......... 16-234 ISO 7176-14 Third Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 14 newer version.
Power and control
systems for
electrically powered
wheelchairs and
scooters--Requirement
s and test methods.
16-194.......... 16-235 ISO 7176-25 Second Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 25: newer version.
Lead-acid batteries
and chargers for
powered wheelchairs--
Requirements and test
methods.
16-201.......... 16-236 ISO 7176-19 Third Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 19: newer version.
Wheeled mobility
devices for use as
seats in motor
vehicles.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-6............ 12-350 IEC 60806 Edition 2.0 Withdrawn and
2022-11 Determination replaced with
of the maximum newer version.
symmetrical radiation
field of X-ray tube
assemblies and X-ray
source assemblies for
medical diagnosis.
12-347.......... ............ IEC 60601-2-33 Edition Transition
4.0 2022-08 Medical period
electrical equipment-- extended.
Part 2-33: Particular
requirements for the
basic safety and
essential performance
of magnetic resonance
equipment for medical
diagnosis.
12-329.......... 12-351 IEC 60601-2-43 Edition Withdrawn and
3.0 2022-12 Medical replaced with
electrical equipment-- newer version.
Part 2-43: Particular
requirements for the
basic safety and
essential performance
of X-ray equipment
for interventional
procedures.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-169.......... 14-584 ASTM F2391-22 Standard Withdrawn and
Test Method for replaced with
Measuring Package and newer version.
Seal Integrity Using
Helium as the Tracer
Gas.
14-456.......... 14-585 ISO/TS 16775 Second Withdrawn and
edition 2021-11 replaced with
Packaging for newer version.
terminally sterilized
medical devices--
Guidance on the
application of ISO
11607-1 and ISO 11607-
2.
14-575.......... ............ ASTM F1980-21 Standard Transition
Guide for Accelerated period
Aging of Sterile extended.
Barrier Systems for
Medical Devices.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
III. Listing of New Entries
In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 060. 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
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-185................ Active implantable medical ANSI/AAMI PC76:2021.
devices--Requirements and
test protocols for safety
of patients with
pacemakers and ICDs
exposed to magnetic
resonance imaging.
3-186................ Implants for surgery-- ISO 14708-2 Third
Active implantable edition 2019-09.
medical devices--Part 2:
Cardiac pacemakers.
3-187................ Implants for surgery-- ISO 14708-6 Second
Active implantable edition 2019-09.
medical devices--Part 6:
Particular requirements
for active implantable
medical devices intended
to treat tachyarrhythmia
(including implantable
defibrillators).
[[Page 52178]]
3-188................ Non-invasive ISO 81060-3 First
sphygmomanometers--Part edition 2022-12.
3: Clinical investigation
of continuous automated
measurement type.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-305................ Dentistry--Central suction ISO 10637 Second
source equipment. edition 2018-05.
4-306................ Dentistry--Compressed air ISO 22052 First
source equipment. edition 2020-06.
4-307................ Dentistry--General ISO 13504 First
requirements for edition 2012-07.
instruments and related
accessories used in
dental implant placement
and treatment.
4-308................ Implants for surgery-- ISO 14708-7 Second
Active implantable edition 2019-12
medical devices--Part 7: (Corrected version
Particular requirements 2020-05).
for cochlear and auditory
brainstem implant systems.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
19-49................ Medical electrical IEC 60601-1 Edition
equipment--Part 1: 3.2 2020-08
General requirements for CONSOLIDATED
basic safety and VERSION.
essential performance.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
6-495................ Catheter systems for ISO 20698 First
neuraxial application-- Edition 2018-07.
Sterile and single-use
catheters and accessories.
6-496................ Standard Test Method for ASTM F739-20.
Permeation of Liquids and
Gases Through Protective
Clothing Materials Under
Conditions of Continuous
Contact.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-604................ Standard Specification for ASTM F2257-22.
Wrought Seamless or
Welded and Drawn
18Chromium-14Nickel-
2.5Molybdenum Stainless
Steel Small Diameter
Tubing for Surgical
Implants (UNS S31673).
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-149................ Medical electrical IEC 60601-2-39
equipment--Part 2-39: Edition 3.0 2018-04.
Particular requirements
for basic safety and
essential performance of
peritoneal dialysis
equipment.
------------------------------------------------------------------------
[[Page 52179]]
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
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-586............... Sterilization of health ISO 22441 First
care products--Low edition 2022-08.
temperature vaporized
hydrogen peroxide--
Requirements for the
development, validation
and routine control of a
sterilization process for
medical devices.
14-587............... Guidance on transferring AAMI TIR104:2022.
health care products
between radiation
sterilization sources.
14-588............... Compatibility of materials AAMI TIR17:2017/
subjected to (R)2020.
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.
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: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16770 Filed 8-4-23; 8:45 am]
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