[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52473-52479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13777]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 062

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 062'' (Recognition List Number: 062), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at 
any time. These modifications to the list of recognized standards are 
applicable June 24, 2024.

ADDRESSES: You may submit comments on the current list of FDA 
Recognized Consensus Standards at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 062.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. 
FDA will consider any comments received in determining whether to amend 
the current listing of modifications to the list of recognized 
standards, Recognition List Number: 062.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not

[[Page 52474]]

in the body of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    An electronic copy of Recognition List Number: 062 is available on 
the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for 
electronic access to the searchable database for the current list of 
FDA-recognized consensus standards, including Recognition List Number: 
062 modifications and other standards-related information. Submit 
written requests for a single hard copy of the document entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 062'' to Terry Woods, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Silver Spring, MD 20993, 301-796-2503. Send one self-addressed 
adhesive label to assist that office in processing your request or fax 
your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Terry Woods, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-2503, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 
of the FD&C Act allows FDA to recognize consensus standards developed 
by international and national organizations for use in satisfying 
portions of device premarket review submissions or other requirements.
    In the Federal Register of September 14, 2018 (83 FR 46738), FDA 
announced the availability of a guidance entitled ``Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.'' The guidance describes how FDA has implemented its standards 
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. 
Modifications to the initial list of recognized standards, as published 
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains on its 
website HTML and PDF versions of the list of FDA Recognized Consensus 
Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. 
Additional information on the Agency's Division of Standards and 
Conformity Assessment is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 062

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency is recognizing for 
use in premarket submissions and other requirements for devices. FDA is 
incorporating these modifications to the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA is using 
the term ``Recognition List Number: 062'' to identify the current 
modifications.
    In table 1, FDA describes the following modifications: (1) the 
withdrawal of standards and their replacement by others, if applicable; 
(2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that 
involve new entries and consensus standards added as modifications to 
the list of recognized standards under Recognition List Number: 062.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                    Replacement
 Old recognition    recognition  Title of standard \1\       Change
       No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-81.............         1-167  CGA V-5:2019 Standard  Withdrawn and
                                  for Diameter Index     replaced with
                                  Safety System          newer version.
                                  (Noninterchangeable
                                  Low Pressure
                                  Connections for
                                  Medical Gas
                                  Applications).
1-97.............         1-168  CGA V-7.1:2021         Withdrawn and
                                  Standard Method of     replaced with
                                  Determining Cylinder   newer version.
                                  Valve Outlet
                                  Connections for
                                  Medical Gases.
1-100............         1-169  CGA V-1:2021 Standard  Withdrawn and
                                  for Compressed Gas     replaced with
                                  Cylinder Valve         newer version.
                                  Outlet and Inlet
                                  Connections.
1-101............         1-170  CGA C-9:2019 Standard  Withdrawn and
                                  Color Marking of       replaced with
                                  Compressed Gas         newer version.
                                  Containers for
                                  Medical Use.
1-103............         1-171  ISO 5367 Sixth         Extent of
                                  edition 2023-07        recognition.
                                  Anaesthetic and        Withdrawn and
                                  respiratory            replaced with
                                  equipment--Breathing   newer version.
                                  sets and connectors.
1-126............         1-172  ISO 11712 Second       Withdrawn and
                                  edition 2023-11        replaced with
                                  Anaesthetic and        newer version.
                                  respiratory
                                  equipment--Supralary
                                  ngeal airways and
                                  connectors.
1-134............         1-173  ISO 18562-1 Second     Withdrawn and
                                  edition 2024-03        replaced with
                                  Biocompatibility       newer version.
                                  evaluation of
                                  breathing gas
                                  pathways in
                                  healthcare
                                  applications--Part
                                  1: Evaluation and
                                  testing within a
                                  risk management
                                  process.

[[Page 52475]]

 
1-135............         1-174  ISO 18562-2 Second     Withdrawn and
                                  edition 2024-03        replaced with
                                  Biocompatibility       newer version.
                                  evaluation of
                                  breathing gas
                                  pathways in
                                  healthcare
                                  applications--Part
                                  2: Tests for
                                  emissions of
                                  particulate matter.
1-136............         1-175  ISO 18562-3 Second     Withdrawn and
                                  edition 2024-03        replaced with
                                  Biocompatibility       newer version.
                                  evaluation of
                                  breathing gas
                                  pathways in
                                  healthcare
                                  applications--Part
                                  3: Tests for
                                  emissions of
                                  volatile organic
                                  substances.
1-137............         1-176  ISO 18562-4 Second     Withdrawn and
                                  edition 2024-03        replaced with
                                  Biocompatibility       newer version.
                                  evaluation of
                                  breathing gas
                                  pathways in
                                  healthcare
                                  applications--Part
                                  4: Tests for
                                  leachables in
                                  condensate.
1-138............         1-177  ISO 80601-2-74 Second  Withdrawn and
                                  edition 2021-07        replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  74: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of
                                  respiratory
                                  humidifying
                                  equipment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-163............         3-191  ISO 18242 First        Withdrawn and
                                  edition 2016-09-01     replaced with
                                  [Including             newer version.
                                  AMD1:2023]
                                  Cardiovascular
                                  implants and
                                  extracorporeal
                                  systems--Centrifugal
                                  blood pumps
                                  [Including AMENDMENT
                                  1 (2023)].
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-215............         4-325  ANSI/ADA Standard No.  Withdrawn and
                                  96-2020 Dental Water-  replaced with
                                  based Cements.         newer version.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-19............         19-50  IEC TS 60601-4-2       Withdrawn and
                                  Edition 1.0 2024-03    replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 4-2:
                                  Guidance and
                                  interpretation--Elec
                                  tromagnetic
                                  immunity:
                                  performance of
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  systems.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-295............  ............  ANSI AAMI BF7:2012     Withdrawn.
                                  Blood transfusion
                                  microfilters.
6-322............         6-498  ISO 10555-4 Third      Withdrawn and
                                  edition 2023-11        replaced with
                                  Intravascular          newer version.
                                  catheters--Sterile
                                  and single-use
                                  catheters--Part 4:
                                  Balloon dilatation
                                  catheters.
6-408............         6-499  ISO 10555-1 Third      Withdrawn and
                                  edition 2023-11        replaced with
                                  Intravascular          newer version.
                                  catheters--Sterile
                                  and single-use
                                  catheters--Part 1:
                                  General requirements.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-159............         8-611  ISO 9584 Second        Withdrawn and
                                  edition 2023-10        replaced with
                                  Implants for           newer version.
                                  surgery--Nondestruct
                                  ive testing--
                                  Radiographic
                                  examination of cast
                                  metallic surgical
                                  implants.
8-527............         8-612  ASTM F899-23 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Wrought Stainless      newer version.
                                  Steels for Surgical
                                  Instruments.
8-580............  ............  IEC 63145-20-10        Transferred. See
                                  Edition 1.0 2019-08    12-357.
                                  Eyewear display--
                                  Part 20-10:
                                  Fundamental
                                  measurement methods--
                                  Optical properties.
8-581............  ............  IEC 63145-20-20        Transferred. See
                                  Edition 1.0 2019-09    12-358.
                                  Eyewear display--
                                  Part 20-20:
                                  Fundamental
                                  measurement methods--
                                  Image quality.
8-582............  ............  IEC 63145-22-10        Transferred. See
                                  Edition 1.0 2020-01    12-359.
                                  Eyewear display--
                                  Part 22-10: Specific
                                  measurement methods
                                  for AR type--Optical
                                  properties.
------------------------------------------------------------------------

[[Page 52476]]

 
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
17-13............         17-18  IEEE Std 2010-2023     Withdrawn and
                                  Recommended Practice   replaced with
                                  for                    newer version.
                                  Electroencephalograp
                                  hy (EEG)
                                  Neurofeedback
                                  Systems.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-56............  ............  ANSI Z80.12-2007       Withdrawn with
                                  (R2022) American       transition. See
                                  National Standard      10-135.
                                  for Ophthalmics--
                                  Multifocal
                                  Intraocular Lenses.
10-70............        10-134  ISO 10943 Fourth       Withdrawn and
                                  edition 2023-01--      replaced with
                                  ophthalmic             newer version.
                                  instruments--Indirec
                                  t ophthalmoscopes.
10-125...........        10-135  ISO 11979-7 Fifth      Withdrawn and
                                  edition 2024-01        replaced with
                                  Ophthalmic implants--  newer version.
                                  Intraocular lenses--
                                  Part 7: Clinical
                                  investigations of
                                  intraocular lenses
                                  that are implanted
                                  in the eye in order
                                  to correct aphakia.
10-126...........        10-136  IEC 80601-2-58         Withdrawn and
                                  Edition 3.0 2024-03    replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  58: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of lens
                                  removal devices and
                                  vitrectomy devices
                                  for ophthalmic
                                  surgery.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-232...........        12-354  NEMA MS 4-2023         Withdrawn and
                                  Acoustic Noise         replaced with
                                  Measurement            newer version.
                                  Procedure for
                                  Magnetic Resonance
                                  Equipment.
12-242...........        12-355  IEC 60601-2-57         Withdrawn and
                                  Edition 2.0 2023-07    replaced with
                                  Medical Electrical     newer version.
                                  Equipment--Part 2-
                                  57: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of non-
                                  laser light source
                                  equipment intended
                                  for therapeutic,
                                  diagnostic,
                                  monitoring, cosmetic
                                  and aesthetic use.
12-268...........        12-356  IEC 60601-2-22         Withdrawn and
                                  Edition 4.0 2019-11    replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  22: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of
                                  surgical, cosmetic,
                                  therapeutic and
                                  diagnostic laser
                                  equipment.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-52............        13-132  ISO/IEEE 11073-10408   Withdrawn and
                                  Second edition 2022-   replaced with
                                  12 Health              newer version.
                                  informatics--Point-
                                  of-care medical
                                  device
                                  communication--Part
                                  10408: Device
                                  specialization--Ther
                                  mometer.
13-53............        13-133  ISO/IEEE 11073-10415   Withdrawn and
                                  Second edition 2022-   replaced with
                                  12 Health              newer version.
                                  informatics--Point-
                                  of-care medical
                                  device
                                  communication--Part
                                  10415: Device
                                  specialization-
                                  Weighing scale.
13-54............        13-134  ISO/IEEE 11073-10404   Withdrawn and
                                  Second edition 2022-   replaced with
                                  12 Health              newer version.
                                  informatics--Persona
                                  l health device
                                  communication--Part
                                  10404: Device
                                  specialization--Puls
                                  e oximeter.
13-57............        13-135  ISO/IEEE 11073-10407   Withdrawn and
                                  Second edition 2022-   replaced with
                                  12 Health              newer version.
                                  informatics--Persona
                                  l health device
                                  communication--Part
                                  10407: Device
                                  Specialization--Bloo
                                  d pressure monitor.
13-113...........        13-136  ISO/IEEE 11073-20601   Withdrawn and
                                  Third Edition 2022-    replaced with
                                  12 Health              newer version.
                                  informatics--Persona
                                  l health device
                                  communication--Part
                                  20601: Application
                                  profile--Optimized
                                  exchange protocol.
13-114...........        13-137  IEEE Std 11073-10101b- Withdrawn and
                                  2023 Health            replaced with
                                  informatics--Point-    newer version.
                                  of-care medical
                                  device
                                  communication--Part
                                  10101: Nomenclature.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-242...........        14-598  ISO 14644-3 Second     Withdrawn and
                                  edition 2020-06        replaced with
                                  Cleanrooms and         newer version.
                                  associated
                                  controlled
                                  environments--Part
                                  3: Test methods.

[[Page 52477]]

 
14-243...........  ............  ISO 14644-6 First      Withdrawn.
                                  edition 2007-07
                                  Cleanrooms and
                                  associated
                                  controlled
                                  environments--Part
                                  6: Vocabulary.
14-277...........  ............  ISO TS 17665-2 First   Withdrawn with
                                  edition 2009-01        transition. See
                                  Sterilization of       14-601.
                                  health care
                                  products--Moist
                                  heat--Part 2:
                                  Guidance on the
                                  application of ISO
                                  17665-1.
14-333...........  ............  ISO 17665-1 First      Withdrawn with
                                  edition 2006-08        transition. See
                                  Sterilization of       14-601.
                                  health care
                                  products--Moist
                                  heat--Part 1:
                                  Requirements for the
                                  development,
                                  validation and
                                  routine control of a
                                  sterilization
                                  process for medical
                                  devices.
14-389...........        14-599  ISO 14644-9 Second     Withdrawn and
                                  edition Cleanrooms     replaced with
                                  and associated         newer version.
                                  controlled
                                  environments--Part
                                  9: Assessment of
                                  surface cleanliness
                                  for particle
                                  concentration.
14-484...........        14-600  ASTM F1929-23          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Detecting Seal     newer version.
                                  Leaks in Porous
                                  Medical Packaging by
                                  Dye Penetration.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 062. These entries are of standards not 
previously recognized by FDA.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
     Recognition No.         Title of standard \1\           date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-178....................  Anaesthetic and           ISO 23747 Second
                            respiratory equipment--   edition 2015-08.
                            Peak expiratory flow
                            meters for the
                            assessment of pulmonary
                            function in
                            spontaneously breathing
                            humans.
1-179....................  Anaesthetic and           ISO 26782 First
                            respiratory equipment--   edition 2009-07.
                            Spirometers intended
                            for the measurement of
                            time forced expired
                            volumes in humans
                            [Including: Technical
                            Corrigendum 1 (2009)].
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-192....................  Cardiovascular implants-- ISO 22679 First
                            Transcatheter cardiac     edition 2021-11.
                            occluders.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-326....................  Dentistry--Graphical      ISO 9687 Second
                            symbols for dental        edition 2015-02.
                            equipment [Including
                            AMENDMENT 1 (2018)].
4-327....................  Dentistry--Graphical      ISO 21531 First
                            symbols for dental        edition 2009-02.
                            instruments.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
5-142....................  Packaging--Distribution   ISO 780 Fifth
                            packaging--Graphical      edition 2015-12-
                            symbols for handling      01.
                            and storage of packages.
------------------------------------------------------------------------
                         F. General II (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-500....................  Ultrasonics--Non-         IEC 63045 Edition
                            focusing short pressure   1.0 2020-05.
                            pulse sources including
                            ballistic pressure
                            pulse sources--
                            Characteristics of
                            fields.
6-501....................  Plastic containers for    ISO 15747 Third
                            intravenous injections.   edition 2018-09.
6-502....................  Injection systems for     ISO 23217 First
                            self-administration by    edition 2024-02.
                            paediatric patients--
                            Requirements and
                            guidelines for design.
------------------------------------------------------------------------

[[Page 52478]]

 
                                 H. IVD
------------------------------------------------------------------------
7-321....................  Molecular Methods for     CLSI MM24 1st
                            Genotyping and Strain     Edition.
                            Typing of Infectious
                            Organisms.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-613....................  Standard Specification    ASTM F2527-24.
                            for Wrought Seamless
                            and Welded and Drawn
                            Cobalt Alloy Small
                            Diameter Tubing for
                            Surgical Implants.
8-614....................  Standard Guide for        ASTM F3456-22.
                            Powder Reuse Schema in
                            Powder Bed Fusion
                            Processes for Medical
                            Applications for
                            Additive Manufacturing
                            Feedstock Materials.
8-615....................  Additive manufacturing    ISO/ASTM 52926-1
                            of metals--               First edition 2023-
                            Qualification             11.
                            principles--Part 1:
                            General qualification
                            of operators.
8-616....................  Additive manufacturing    ISO/ASTM 52926-2
                            of metals--               First edition 2023-
                            Qualification             11.
                            principles--Part 2:
                            Qualification of
                            operators for PBF-LB.
8-617....................  Additive manufacturing    ISO/ASTM 52926-3
                            of metals--               First edition 2023-
                            Qualification             11.
                            principles--Part 3:
                            Qualification of
                            operators for PBF-EB.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
17-19....................  Medical electrical        ISO 80601-2-85
                            equipment--Part 2-85:     Edition 1.0 2021-
                            Particular requirements   03.
                            for the basic safety
                            and essential
                            performance of cerebral
                            tissue oximeter
                            equipment.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-357...................  Eyewear display--Part 20- IEC 63145-20-10
                            10: Fundamental           Edition 1.0 2019-
                            measurement methods--     08.
                            Optical properties.
12-358...................  Eyewear display--Part 20- IEC 63145-20-20
                            20: Fundamental           Edition 1.0 2019-
                            measurement methods--     09.
                            Image quality.
12-359...................  Eyewear display--Part 22- IEC 63145-22-10
                            10: Specific              Edition 1.0 2020-
                            measurement methods for   01.
                            AR type--Optical
                            properties.
12-360...................  Eyewear display--Part     IEC 63145-10
                            10: Specifications.       Edition 1.0 2023-
                                                      09.
12-361...................  Information Display       ICDM IDMS Version
                            Measurements Standard.    1.2 May 2023.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-138...................  Health Informatics--      IEEE Std 11073-
                            Device Interoperability   10700-2022.
                            Part 10700: Point-of-
                            Care Medical Device
                            Communication--Standard
                            for Base Requirements
                            for Participants in a
                            Service-Oriented Device
                            Connectivity (SDC)
                            System.
13-139...................  Health informatics--      IEEE Std 11073-
                            Device                    10206-2022.
                            interoperability--Part
                            10206: Personal health
                            device communication--
                            Abstract Content
                            Information Model.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-601...................  Sterilization of health   ISO 17665 First
                            care products--Moist      edition 2024-03.
                            heat--Requirements for
                            the development,
                            validation and routine
                            control of a
                            sterilization process
                            for medical devices.
14-602...................  Designing, testing, and   AAMI TIR12:2020/
                            labeling medical          (R)2023.
                            devices intended for
                            processing by health
                            care facilities: A
                            guide for device
                            manufacturers.
14-603...................  Product adoption and      AAMI TIR28:2016/
                            process equivalence for   (R)2020.
                            ethylene oxide
                            sterilization.
------------------------------------------------------------------------

[[Page 52479]]

 
                          S. Tissue Engineering
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such 
standards are those that FDA has recognized by notice published in the 
Federal Register or that FDA has decided to recognize but for which 
recognition is pending (because a periodic notice has not yet appeared 
in the Federal Register). FDA will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
[email protected]. To be considered, such recommendations 
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13777 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P