[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48671-48676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17150]


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

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: 058

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: 058'' (Recognition List Number: 058), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Either electronic or written comments can be submitted on the 
notice at any time. These modifications to the list of recognized 
standards are applicable August 10, 2022.

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

[[Page 48672]]

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: 058.'' 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: 058.
     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: 058 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: 
058 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: 058'' to Jianchao Zeng, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. Send one self-
addressed adhesive label to assist that office in processing your 
request, or Fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Jianchao Zeng, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

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

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 058

    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: 058'' 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: 058.

[[Page 48673]]



       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
      Old          recognition   Title of standard \1\       Change
recognition No.        No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-174..........           2-296  ISO 10993-10 Fourth    Withdrawn and
                                  edition 2021-11        replaced with
                                  Biological             newer version.
                                  evaluation of
                                  medical devices--
                                  Part 10: Tests for
                                  skin sensitization.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-116..........           3-181  ISO 25539-2 Third      Withdraw and
                                  edition 2020-09        replaced with
                                  Cardiovascular         newer version.
                                  implants--Endovascul
                                  ar devices--Part 2:
                                  Vascular stents.
3-137..........           3-182  ASTM F3036-21          Withdrawn and
                                  Standard Guide for     replaced with
                                  Testing Absorbable     newer version.
                                  Stents.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-236..........           4-293  ANSI/ADA Standard No.  Withdrawn and
                                  119-2021 Manual        replaced with
                                  Toothbrushes.          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)
------------------------------------------------------------------------
19-4...........           19-46  ANSI/AAMI ES60601-     Withdrawn and
                                  1:2005/(R)2012 and     replaced with
                                  A1:2012, C1:2009/      newer version.
                                  (R)2012 and A2:2010/
                                  (R)2012
                                  (Consolidated Text)
                                  Medical electrical
                                  equipment--Part 1:
                                  General requirements
                                  for basic safety and
                                  essential
                                  performance (IEC
                                  60601-1:2005, MOD)
                                  [Including Amendment
                                  2 (2021)].
19-16..........           19-47  ANSI/AAMI HA60601-1-   Withdrawn and
                                  11:2015 Medical        replaced with
                                  Electrical             newer version.
                                  Equipment--Part 1-
                                  11: General
                                  requirements for
                                  basic safety and
                                  essential
                                  performance--Collate
                                  ral Standard:
                                  Requirements for
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  systems used in the
                                  home healthcare
                                  environment (IEC
                                  60601-1-11:2015 MOD)
                                  [Including AMD
                                  1:2021].
19-30..........           19-45  AIM Standard 7351731   Withdrawn and
                                  Rev. 3.00 2021-06-04   replaced with
                                  Medical Electrical     newer version.
                                  Equipment and System
                                  Electromagnetic
                                  Immunity Test for
                                  Exposure to Radio
                                  Frequency
                                  Identification
                                  Readers--An AIM
                                  Standard.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-174..........           6-475  ISO 11608-4:2022       Withdrawn and
                                  Needle-based           replaced with
                                  injection systems      newer version.
                                  for medical use--
                                  Requirements and
                                  test methods--Part
                                  4: Needle-based
                                  injection systems
                                  containing
                                  electronics.
6-275..........           6-476  ISO 11608-2:2022       Withdrawn and
                                  Needle-based           replaced with
                                  injection systems      newer version.
                                  for medical use--
                                  Requirements and
                                  test methods--Part
                                  2: Double-ended pen
                                  needles.
6-294..........           6-477  ISO 11608-3:2022       Withdrawn and
                                  Needle-based           replaced with
                                  injection systems      newer version.
                                  for medical use--
                                  Requirements and
                                  test methods--Part
                                  3: Containers and
                                  integrated fluid
                                  path.
6-341..........           6-478  ISO 11608-1:2022       Withdrawn and
                                  Needle-based           replaced with
                                  injection systems      newer version.
                                  for medical use--
                                  Requirements and
                                  test methods--Part
                                  1: Needle-based
                                  injection systems.
6-377..........           6-479  ISO 11608-5:2022       Withdrawn and
                                  Needle-based           replaced with
                                  injection systems      newer version.
                                  for medical use--
                                  Requirements and
                                  test methods--Part
                                  5: Automated
                                  functions.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-303..........  ..............  CLSI M60 2nd Edition   Extent of
                                  Performance            recognition.
                                  Standards for
                                  Antifungal
                                  Susceptibility
                                  Testing of Yeast.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-336..........           8-583  ASTM F562-22 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Wrought 35Cobalt-      newer version.
                                  35Nickel-20Chromium-
                                  10Molybdenum Alloy
                                  for Surgical Implant
                                  Applications (UNS
                                  R30035).
8-347..........           8-584  ASTM F2146-22          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Wrought Titanium-
                                  3Aluminum-
                                  2.5Vanadium Alloy
                                  Seamless Tubing for
                                  Surgical Implant
                                  Applications (UNS
                                  R56320).

[[Page 48674]]

 
8-354..........           8-585  ASTM F1377-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Cobalt-28Chromium-
                                  6Molybdenum Powder
                                  for Medical Devices
                                  (UNS R30075, UNS
                                  R31537, and UNS
                                  R31538).
8-362..........           8-586  ASTM F2989-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Metal Injection
                                  Molded Unalloyed
                                  Titanium Components
                                  for Surgical Implant
                                  Applications.
8-447..........           8-587  ISO 5832-3 Fifth       Withdrawn and
                                  Edition 2021-11        replaced with
                                  Implants for           newer version.
                                  surgery--Metallic
                                  materials--Part 3:
                                  Wrought titanium 6-
                                  aluminium 4-vanadium
                                  alloy.
8-469..........           8-588  ASTM F560-22 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Unalloyed Tantalum     newer version.
                                  for Surgical Implant
                                  Applications (UNS
                                  R05200, UNS R05400).
8-471..........           8-589  ASTM F1925-22          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Semi-Crystalline
                                  Poly(lactide)
                                  Polymer and
                                  Copolymer Resins for
                                  Surgical Implants.
8-525..........           8-590  ISO/TS 17137 Third     Withdrawn and
                                  Edition 2021-09        replaced with
                                  Cardiovascular         newer version.
                                  implants and
                                  extracorporeal
                                  systems--Cardiovascu
                                  lar absorbable
                                  implants.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-110.........          10-131  ISO 15798 Fourth       Withdrawn and
                                  edition 2022-01        replaced with
                                  Ophthalmic implants--  newer version.
                                  Ophthalmic
                                  viscosurgical
                                  devices.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-166.........  ..............  ISO 7176-21 Second     Extent of
                                  edition 2009-04-01     recognition
                                  Wheelchairs--Part
                                  21: Requirements and
                                  test methods for
                                  electromagnetic
                                  compatibility of
                                  electrically powered
                                  wheelchairs and
                                  scooters, and
                                  battery chargers.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-277.........          12-343  IEC 62127-1 Edition    Withdrawn and
                                  2.0 2022-03            replaced with
                                  Ultrasonics--Hydroph   newer version.
                                  ones--Part 1:
                                  Measurement and
                                  characterization of
                                  medical ultrasonic
                                  fields.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-478.........          14-572  ANSI/AAMI ST91:2021    Withdrawn and
                                  Flexible and semi-     replaced with
                                  rigid endoscope        newer version.
                                  processing in health
                                  care facilities.
14-482.........          14-573  ASTM F88/F88M-21       Withdrawn and
                                  Standard Test Method   replaced with
                                  for Seal Strength of   newer version.
                                  Flexible Barrier
                                  Materials.
14-496.........          14-574  ASTM F1608-21          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Microbial          newer version.
                                  Ranking of Porous
                                  Packaging Materials
                                  (Exposure Chamber
                                  Method).
14-497.........          14-575  ASTM F1980-21          Withdrawn and
                                  Standard Guide for     replaced with
                                  Accelerated Aging of   newer version.
                                  Sterile Barrier
                                  Systems and Medical
                                  Devices.
14-499.........          14-576  ASTM D4169-22          Withdrawn and
                                  Standard Practice      replaced with
                                  for Performance        newer version.
                                  Testing of Shipping
                                  Containers and
                                  Systems.
14-514.........          14-577  ISO 11737-1 Third      Withdrawn and
                                  edition 2018-01        replaced with
                                  [Including: AMD1       newer version.
                                  (2021)]
                                  Sterilization of
                                  health care
                                  products--Microbiolo
                                  gical methods--Part
                                  1: Determination of
                                  a population of
                                  microorganisms on
                                  product [Including:
                                  Amendment 1 (2021)].
14-515.........          14-578  ISO 17664-1 First      Extent of
                                  edition 2021-07        Recognition.
                                  Processing of health   Withdrawn and
                                  care products--        replaced with
                                  Information to be      newer version.
                                  provided by the
                                  medical device
                                  manufacturer for the
                                  processing of
                                  medical devices--
                                  Part 1: Critical and
                                  semi-critical
                                  medical devices.
------------------------------------------------------------------------

[[Page 48675]]

 
                          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: 058. 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
------------------------------------------------------------------------
1-152................  Medical electrical          ISO 80601-2-87 First
                        equipment--Part 2-87:       edition 2021-04.
                        Particular requirements
                        for basic safety and
                        essential performance of
                        high-frequency
                        ventilators.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
15-135...............  Medical devices--           ISO 20417 First
                        Information to be           edition 2021-04
                        supplied by the             Corrected version
                        manufacturer.               2021-12.
------------------------------------------------------------------------
                         F. General II (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
6-480................  Needle-based injection      ISO 11608-6:2022.
                        systems for medical use--
                        requirements and test
                        methods--Part 6: On-body
                        delivery systems.
6-481................  General requirements for    ANSI/AAMI CN27:2021.
                        Luer activated valves
                        (LAVs) incorporated into
                        medical devices for
                        intravascular
                        applications.
6-482................  Fluid delivery performance  AAMI TIR101:2021.
                        testing for infusion
                        pumps.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
7-312................  Analysis and Presentation   CLSI M39 5th Edition.
                        of Cumulative
                        Antimicrobial
                        Susceptibility Test Data.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-591................  Standard Specification for  ASTM F2229-21.
                        Wrought, Nitrogen
                        Strengthened 23Manganese-
                        21Chromium-1Molybdenum
                        Low-Nickel Stainless
                        Steel Alloy Bar and Wire
                        for Surgical Implants
                        (UNS S29108).
8-592................  Standard Specification for  ASTM F3384-21.
                        Polydioxanone Polymer
                        Resins for Surgical
                        Implants.
8-593................  Implants for surgery--      ISO 13779-6 First
                        Hydroxyapatite--Part 6:     edition 2015-01-15
                        Powders.                    Corrected Version
                                                    2016-09-15.
------------------------------------------------------------------------

[[Page 48676]]

 
                            J. Nanotechnology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-139................  Colorimetry--Part 5: CIE    ISO/CIE 11664-5:2016.
                        1976 L*u*v* colour space
                        and u',v' uniform
                        chromaticity scale
                        diagram.
------------------------------------------------------------------------
                              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
------------------------------------------------------------------------
12-344...............  Medical electrical          IEC 62563-2 Edition
                        equipment--Medical image    1.0 2021-11.
                        display systems--Part 2:
                        Acceptance and constancy
                        tests for medical image
                        displays.
12-345...............  Evaluation and routine      IEC 61223-3-7 Edition
                        testing in medical          1.0 2021-12.
                        imaging departments--Part
                        3-7: Acceptance and
                        constancy tests--Imaging
                        performance of X-ray
                        equipment for dental cone
                        beam computed tomography.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-579...............  Processing of health care   ISO 17664-2 First
                        products--Information to    edition 2021-02.
                        be provided by the
                        medical device
                        manufacturer for the
                        processing of medical
                        devices--Part 2: Non-
                        critical 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: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17150 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P


