
[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Notices]
[Pages 50870-50876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16418]


-----------------------------------------------------------------------

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: 059

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: 059'' (Recognition List Number: 059), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

[[Page 50871]]


DATES: Submit either electronic or written comments on the notice at 
any time. These modifications to the list of recognized standards are 
applicable August 2, 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 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: 059.'' 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: 059.
     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: 059 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: 
059 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: 059'' 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.

[[Page 50872]]

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 059

    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: 059'' 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: 059.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
Old recognition    recognition   Title of standard \1\       Change
      No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-67...........           1-153  NFPA 99:2021 Health    Withdrawn and
                                  Care Facilities Code.  replaced with
                                                         newer version.
1-78...........           1-154  ASME PVHO-1-2019       Withdrawn and
                                  Safety Standard for    replaced with
                                  Pressure Vessels for   newer version.
                                  Human Occupancy.
1-132..........           1-155  ISO 10079-2 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 2:
                                  Manually powered
                                  suction equipment.
1-133..........           1-156  ISO 10079-3 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 3:
                                  Suction equipment
                                  powered from a
                                  vacuum or positive
                                  pressure gas source.
1-142..........           1-157  ISO 10079-1 Fourth     Withdrawn and
                                  edition 2022-03        replaced with
                                  Medical suction        newer version.
                                  equipment--Part 1:
                                  Electrically powered
                                  suction equipment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-93...........           2-297  ASTM F763-22 Standard  Withdrawn and
                                  Practice for Short-    replaced with
                                  Term Intramuscular     newer version.
                                  Screening of
                                  Implantable Medical
                                  Device Materials.
2-276..........           2-298  ISO 10993-18 Second    Withdrawn and
                                  edition 2020-01        replaced with
                                  Amendment 1:2022-05    newer version,
                                  Biological             including
                                  evaluation of          amendment.
                                  medical devices--
                                  Part 18: Chemical
                                  characterization of
                                  medical device
                                  materials within a
                                  risk management
                                  process [Including
                                  Amendment 1 (2022)].
2-289..........  ..............  ISO 10993-12 Fifth     Transition
                                  edition 2021-01        period
                                  Biological             extended.
                                  evaluation of
                                  medical devices--
                                  Part 12: Sample
                                  preparation and
                                  reference materials.
2-296..........  ..............  ISO 10993-10 Fourth    Transition
                                  edition 2021-11        period
                                  Biological             extended.
                                  evaluation of
                                  medical devices--
                                  Part 10: Tests for
                                  skin sensitization.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                     D. Dental/Ear, Nose, and Throat
------------------------------------------------------------------------
4-234..........           4-294  ANSI/ADA Standard No.  Withdrawn and
                                  139-2020 Dental Base   replaced with
                                  Polymers.              newer version.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
15-135.........           5-135  ISO 20417 First        New recognition
                                  edition 2021-04        number.
                                  Corrected version
                                  2021-12 Medical
                                  devices--Information
                                  to be supplied by
                                  the manufacturer.
5-99...........           5-136  ASTM D4332-22          Withdrawn and
                                  Standard Practice      replaced with
                                  for Conditioning       newer version.
                                  Containers,
                                  Packages, or
                                  Packaging Components
                                  for Testing.
5-104..........           5-137  IEC TR 60878 Edition   Withdrawn and
                                  4.0 2022-11            replaced with
                                  Graphical symbols      newer version.
                                  for electrical
                                  equipment in medical
                                  practice.
5-118..........           5-138  AAMI TIR66:2017/       New recognition
                                  (R)2020 Guidance for   number.
                                  the creation of
                                  physiologic data and
                                  waveform databases
                                  to demonstrate
                                  reasonable assurance
                                  of the safety and
                                  effectiveness of
                                  alarm system
                                  algorithms.
5-119..........           5-139  ISO 18250-3 First      New recognition
                                  edition 2018-06        number.
                                  Medical devices--
                                  Connectors for
                                  reservoir delivery
                                  systems for
                                  healthcare
                                  applications--Part
                                  3: Enteral
                                  application.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-29..........           19-48  IEEE ANSI/USEMCSC      Withdrawn and
                                  C63.27 American        replaced with
                                  National Standard      newer version.
                                  for Evaluation of
                                  Wireless Coexistence.
------------------------------------------------------------------------

[[Page 50873]]

 
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-390..........  ..............  IEC 80601-2-35         Withdrawn. See 6-
                                  Edition 2.1 2016-04    483.
                                  CONSOLIDATED VERSION
                                  Medical electrical
                                  equipment-Part--2-
                                  35: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  heating devices
                                  using blankets, pads
                                  or mattresses and
                                  intended for heating
                                  in medical use
                                  [Including Amendment
                                  1 (2016)].
6-460..........           6-484  ASTM F3502-22a         Extent of
                                  Standard               recognition.
                                  Specification for      Withdrawn and
                                  Barrier Face           replaced with a
                                  Coverings.             newer version.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-291..........           7-313  CLSI EP27 2nd Edition  Extent of
                                  Constructing and       recognition.
                                  Interpreting an        Withdrawn and
                                  Error Grid for         replaced with
                                  Quantitative           newer version.
                                  Measurement
                                  Procedures.
7-303..........  ..............  CLSI M60 2nd Edition   Withdrawn. See 7-
                                  Performance            314.
                                  Standards for
                                  Antifungal
                                  Susceptibility
                                  Testing of Yeast.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-61...........           8-594  ISO 5832-6 Third       Withdrawn and
                                  Edition 2022-03        replaced with
                                  Implants for           newer version.
                                  surgery--Metallic
                                  materials--Part 6:
                                  Wrought cobalt-
                                  nickel-chromium-
                                  molybdenum alloy.
8-123..........           8-595  ISO 5832-5 Fourth      Withdrawn and
                                  Edition 2022-03        replaced with
                                  Implants for           newer version.
                                  surgery--Metallic
                                  materials--Part 5:
                                  Wrought cobalt-
                                  chromium-tungsten-
                                  nickel.
8-559..........           8-596  ASTM D412-16(2021)     Withdrawn and
                                  Standard Test          replaced with
                                  Methods for            newer version.
                                  Vulcanized Rubber
                                  and Thermoplastic
                                  Elastomers--Tension.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-4...........           18-21  ISO/TS 80004-6 Second  Withdrawn and
                                  edition 2021-03        replaced with
                                  Nanotechnologies--Vo   newer version.
                                  cabulary--Part 6:
                                  Nano-object
                                  characterization.
18-12..........           18-22  ISO 17200 First        Withdrawn and
                                  edition 2020-09        replaced with
                                  Nanotechnology--Nano   newer version.
                                  particles in powder
                                  form--Characteristic
                                  s and measurements.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-89...........  ..............  ISO 8638 Third         Withdrawn. See 9-
                                  edition 2010-07-01     140.
                                  Cardiovascular
                                  implants and
                                  extracorporeal
                                  systems--Extracorpor
                                  eal blood circuit
                                  for hemodialyzers,
                                  hemodialfilters, and
                                  hemofilters.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-37..........          10-132  ISO 10942 Third        Extent of
                                  edition 2022-01        recognition.
                                  Ophthalmic             Withdrawn and
                                  instruments--Direct    replaced with
                                  ophthalmoscopes.       newer version.
10-91..........          10-133  ISO 11979-10 Second    Withdrawn and
                                  edition 2018-03        replaced with
                                  Ophthalmic implants--  newer version.
                                  Intraocular lenses--
                                  Part 10: Clinical
                                  investigations of
                                  intraocular lenses
                                  for correction of
                                  ametropia in phakic
                                  eyes.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-264.........          11-394  ASTM F1820-22          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Determining the    newer version.
                                  Forces for
                                  Disassembly of
                                  Modular Acetabular
                                  Devices.
11-306.........          11-395  ASTM F1814-22          Withdrawn and
                                  Standard Guide for     replaced with
                                  Evaluating Modular     newer version.
                                  Hip and Knee Joint
                                  Components.
11-320.........          11-396  ISO 7206-13 First      Withdrawn and
                                  edition 2016-07-01     replaced with
                                  [Including             newer version
                                  AMD1:2022] Implants    including
                                  for surgery--Partial   amendment.
                                  and total hip joint
                                  prostheses--Part 13:
                                  Determination of
                                  resistance to torque
                                  of head fixation of
                                  stemmed femoral
                                  components
                                  [Including Amendment
                                  1 (2022)].
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-191.........  ..............  ISO 7176-16 Second     Withdrawn. See
                                  edition 2012-12-01     16-233.
                                  Wheelchairs--Part
                                  16: Resistance to
                                  ignition of postural
                                  support devices.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-113.........          12-346  ISO 12005 Third        Withdrawn and
                                  edition 2022-05        replaced with
                                  Lasers and laser-      newer version.
                                  related equipment--
                                  Test methods for
                                  laser beam
                                  parameters--Polariza
                                  tion.

[[Page 50874]]

 
12-295.........          12-347  IEC 60601-2-33         Extent of
                                  Edition 4.0 2022-08    recognition.
                                  Medical electrical     Withdrawn and
                                  equipment--Part 2-     replaced with
                                  33: Particular         newer version.
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  magnetic resonance
                                  equipment for
                                  medical diagnosis.
12-317.........          12-348  IEC 60601-2-54         Extent of
                                  Edition 2.0 2022-09    recognition.
                                  Medical electrical     Withdrawn and
                                  equipment--Part 2-     replaced with
                                  54: Particular         newer version.
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of X-ray
                                  equipment for
                                  radiography and
                                  radioscopy.
12-342.........          12-349  NEMA Digital Imaging   Withdrawn and
                                  and Communications     replaced with
                                  in Medicine (DICOM)    newer version.
                                  Set PS3.1-3.20 2022d.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-109.........          13-121  ANSI/AAMI/UL 2800-     Withdrawn and
                                  1:2022 Standard for    replaced with
                                  Medical Device         newer version.
                                  Interoperability.      See 13-125, 13-
                                                         126, 13-127.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-409.........          14-580  ISO 11137-2 Third      Withdrawn and
                                  edition 2013-06        replaced with
                                  [Including             newer version.
                                  AMD1:2022]
                                  Sterilization of
                                  health care
                                  products--Radiation-
                                  -Part 2:
                                  Establishing the
                                  sterilization dose
                                  [Including Amendment
                                  1 (2022)].
14-527.........          14-581  ASTM F2638-22          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Using Aerosol      newer version.
                                  Filtration for
                                  Measuring the
                                  Performance of
                                  Porous Packaging
                                  Materials as a
                                  Surrogate Microbial
                                  Barrier.
------------------------------------------------------------------------
                          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: 059. 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
------------------------------------------------------------------------
1-158................  Medical suction equipment-- ISO 10079-4 First
                        Part 4: General             edition 2021-08.
                        requirements.
1-159................  Respiratory equipment--     ISO 18778 Second
                        Particular requirements     edition 2022-06.
                        for basic safety and
                        essential performance of
                        infant cardiorespiratory
                        monitors.
1-160................  Medical electrical          ISO 80601-2-84 First
                        equipment--Part 2-84:       edition 2020-07.
                        Particular requirements
                        for the basic safety and
                        essential performance of
                        ventilators for the
                        emergency medical
                        services environment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-183................  Cardiovascular implants     ISO 11658 First
                        and extracorporeal          edition 2012-05-15.
                        systems--Blood/tissue
                        contact surface
                        modifications for
                        extracorporeal perfusion
                        systems.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-295................  Evaluation of               ANSI/ADA Standard No.
                        biocompatibility of         41-2020.
                        medical devices used in
                        dentistry.
4-296................  Dentistry--Intra-oral       ISO 9873 Fourth
                        mirrors.                    edition 2019-03.
4-297................  Dentistry--Manual           ISO 20126 Third
                        toothbrushes--General       edition 2022-03.
                        requirements and test
                        methods.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
5-140................  Standard for verification   ASME V&V 10-2019.
                        and validation in
                        computational solid
                        mechanics.
5-141................  Standard for verification   ASME V&V 20-2009
                        and validation in           (R2021).
                        computational fluid
                        dynamics and heat
                        transfer.
------------------------------------------------------------------------

[[Page 50875]]

 
                         F. General II (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-483................  Medical electrical          IEC 60601-2-35
                        equipment--Part 2-35:       Edition 2.0 2020-09.
                        Particular requirements
                        for the basic safety and
                        essential performance of
                        heating devices using
                        blankets, pads and
                        mattresses and intended
                        for heating in medical
                        use.
6-485................  Sterile hypodermic          ISO 7886-4 Second
                        syringes for single use--   Edition 2018-11.
                        Part 4: Syringes with re-
                        use prevention feature.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
7-314................  Performance Standards for   CLSI M27M44S, 3rd
                        Antifungal Susceptibility   Edition.
                        Testing of Yeasts.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-140................  Extracorporeal systems for  ISO 8637-2 First
                        blood purification--Part    Edition 2018-07.
                        2: Extracorporeal blood
                        circuit for
                        hemodialyzers,
                        hemodiafilters and
                        hemofilters.
9-141................  Extracorporeal systems for  ISO 8637-3 First
                        blood purification--Part    Edition 2018-07.
                        3: Plasmafilters.
9-142................  Standard test method for    ASTM D1894-14.
                        static and kinetic
                        coefficients of friction
                        of plastic film and
                        sheeting.
9-143................  Sterile urethral catheters  ISO 20696 First
                        for single use.             edition 2018-06
                                                    Corrected 2019-12.
9-144................  Sterile drainage catheters  ISO 20697 First
                        and accessory devices for   edition 2018-06
                        single use.                 Corrected 2019-09.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-397...............  Standard test method for    ASTM F3210-22e1.
                        fatigue testing of total
                        knee femoral components
                        under closing conditions.
11-398...............  Standard test methods for   ASTM F3574-22.
                        sacroiliac joint fusion
                        devices.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-233...............  Wheelchair seating--Part    ISO 16840-10 Second
                        10: Resistance to           edition 2021-06
                        ignition of postural        Corrected version
                        support devices--           2022-01.
                        Requirements and test
                        method.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-122...............  Health software and health  IEC 81001-5-1 Edition
                        IT systems safety,          1.0 2021-12.
                        effectiveness and
                        security--Part 5-1:
                        Security--Activities in
                        the product life cycle.
13-123...............  Manufacturer disclosure     ANSI/NEMA HN 1-2019.
                        statement for medical
                        device security.
13-124...............  Guidance on the             AAMI CR34971:2022.
                        application of ISO 14971
                        to artificial
                        intelligence and machine
                        learning.
13-125...............  Standard for risk concerns  ANSI/AAMI/UL 2800-1-
                        for interoperable medical   1:2022.
                        products.
13-126...............  Standard for interoperable  ANSI/AAMI/UL 2800-1-
                        item development life       2:2022.
                        cycle.
13-127...............  Standard for Interoperable  ANSI/AAMI/UL 2800-1-
                        item integration life       3:2022.
                        cycle.
13-128...............  IEEE/UL Standard for        IEEE Std 2621.2-2022/
                        wireless diabetes device    UL 2621-2:2022.
                        security: Information
                        security requirements for
                        connected diabetes
                        solutions.
------------------------------------------------------------------------

[[Page 50876]]

 
                              R. Sterility
------------------------------------------------------------------------
14-582...............  Sterilization of health     ISO/TS 11137-4 First
                        care products--Radiation--  edition 2020-06.
                        Part 4: Guidance on
                        process control.
14-583...............  Cleaning validation of      ANSI/AAMI ST98:2022.
                        health care products--
                        Requirements for
                        development and
                        validation of a cleaning
                        process for medical
                        devices..
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

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: July 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16418 Filed 8-1-23; 8:45 am]
BILLING CODE 4164-01-P


