[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24175-24181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08571]



[[Page 24175]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 057

AGENCY: Food and Drug Administration, Health and Human Services (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: 057'' (Recognition List Number: 057), 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 April 22, 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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: 057.'' 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: 057.
    <bullet> 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: 057 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: 
057 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: 057'' to Scott Colburn, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. 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: Scott Colburn, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287, 
<a href="/cdn-cgi/l/email-protection#a1e2e5f3e9f2d5c0cfc5c0d3c5d2f2d5c0c7c7e1c7c5c08fc9c9d28fc6ced7"><span class="__cf_email__" data-cfemail="0d4e495f455e796c63696c7f697e5e796c6b6b4d6b696c2365657e236a627b">[email protected]</span></a>.

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 
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

[[Page 24176]]

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 hypertext markup language (HTML) and portable document format 
(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: 057

    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: 057'' 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: 057.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                   Replacement
Old recognition    recognition   Title of standard \1\       Change
      No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-275..........  ..............  ISO 10993-7 Second     Title change.
                                  edition 2008-10-15
                                  Biological
                                  evaluation of
                                  medical devices--
                                  Part 7: Ethylene
                                  oxide sterilization
                                  residuals
                                  [Including:
                                  Technical
                                  Corrigendum 1
                                  (2009), AMENDMENT 1:
                                  Applicability of
                                  allowable limits for
                                  neonates and infants
                                  (2019)].
2-284..........           2-292  USP-NF M98833_01_01    Withdrawn and
                                  <87> Biological        replaced with
                                  Reactivity Test, In    newer version.
                                  Vitro--Direct
                                  Contact Test.
2-285..........           2-293  USP-NF M98833_01_01    Withdrawn and
                                  <87> Biological        replaced with
                                  Reactivity Test, In    newer version.
                                  Vitro--Elution Test.
2-286..........           2-294  USP-NF M98834_01_01    Withdrawn and
                                  <88> Biological        replaced with
                                  Reactivity Tests, In   newer version.
                                  Vivo.
2-287..........           2-295  USP-NF M98900_01_01    Withdrawn and
                                  <151> Pyrogen Test     replaced with
                                  (USP Rabbit Test)..    newer version.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-88...........           3-171  ASTM F2514-21          Withdrawn and
                                  Standard Guide for     replaced with
                                  Finite Element         newer version.
                                  Analysis (FEA) of
                                  Metallic Vascular
                                  Stents Subjected to
                                  Uniform Radial
                                  Loading.
3-99...........           3-172  AAMI TIR42:2021        Withdrawn and
                                  Evaluation of          replaced with
                                  particulate            newer version.
                                  associated with
                                  vascular medical
                                  devices.
3-133..........           3-173  ISO 5840-3 Second      Withdrawn and
                                  edition 2021-01        replaced with
                                  Cardiovascular         newer version.
                                  implants--Cardiac
                                  valve prostheses--
                                  Part 3: Heart valve
                                  substitutes
                                  implanted by
                                  transcatheter
                                  techniques.
3-145..........           3-174  ISO 5840-1 Second      Withdrawn and
                                  edition 2021-01        replaced with
                                  Cardiovascular         newer version.
                                  implants--Cardiac
                                  valve prostheses--
                                  Part 1: General
                                  requirements.
3-147..........           3-175  ISO 5840-2 Second      Withdrawn and
                                  edition 2021-01        replaced with
                                  Cardiovascular         newer version.
                                  implants--Cardiac
                                  valve prostheses--
                                  Part 2: Surgically
                                  implanted heart
                                  valve substitutes.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-89...........  ..............  ANSI/ADA Standard No.  Withdrawn.
                                  53--2008 (R2013)
                                  Polymer-Based Crown
                                  and Bridge Materials.
------------------------------------------------------------------------
4-282..........           4-284  ISO 10873 Second       Withdrawn and
                                  edition 2021-07        replaced with
                                  Dentistry--Denture     newer version.
                                  adhesives.
------------------------------------------------------------------------

[[Page 24177]]

 
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-117..........           5-134  ISO 15223-1 Fourth     Withdrawn and
                                  edition 2021-07        replaced with
                                  Medical devices--      newer version.
                                  Symbols to be used
                                  with medical device
                                  labels, labelling,
                                  and information to
                                  be supplied--Part 1:
                                  General requirements.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34..........           19-41  ANSI/UL 61010-1 3rd    Withdrawn and
                                  Ed, dated May 12,      replaced with
                                  2012 with revision     newer version.
                                  through July 19,
                                  2019 Standard for
                                  Safety for
                                  Electrical Equipment
                                  For Measurement,
                                  Control and
                                  Laboratory Use; Part
                                  1: General
                                  Requirements.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-365..........           6-464  ISO 11040-4 Third      Withdrawn and
                                  edition 2015-04-01     replaced with
                                  Prefilled syringes--   newer version.
                                  Part 4: Glass
                                  barrels for
                                  injectables and
                                  sterilized
                                  subassembled
                                  syringes ready for
                                  filling [Including
                                  AMENDMENT 1 (2020)].
6-451..........           6-465  USP-NF M76090_03_01    Withdrawn and
                                  Sodium Chloride        replaced with
                                  Irrigation.            newer version.
6-452..........           6-466  USP-NF M76070_03_01    Withdrawn and
                                  Sodium Chloride        replaced with
                                  Injection.             newer version.
6-453..........           6-467  USP-NF M80200_04_01    Withdrawn and
                                  Nonabsorbable          replaced with
                                  Surgical Suture.       newer version.
6-454..........           6-468  USP-NF M99670_02_01    Withdrawn and
                                  <881> Tensile          replaced with
                                  Strength.              newer version.
6-455..........           6-469  USP-NF M99650_02_01    Withdrawn and
                                  <861> Sutures--        replaced with
                                  Diameter.              newer version.
6-456..........           6-470  USP-NF M99660_03_01    Withdrawn and
                                  <871> Sutures--        replaced with
                                  Needle Attachment.     newer version.
6-457..........           6-471  USP-NF M88880_05_01    Withdrawn and
                                  Sterile Water for      replaced with
                                  Irrigation.            newer version.
6-458..........           6-472  USP-NF M36660_04_01    Withdrawn and
                                  Heparin Lock Flush     replaced with
                                  Solution..             newer version.
6-459..........           6-473  USP-NF M80190_04_01    Withdrawn and
                                  Absorbable Surgical    replaced with
                                  Suture.                newer version.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-103..........           8-563  ASTM F1801-20          Withdrawn and
                                  Standard Practice      replaced with
                                  for Corrosion          newer version.
                                  Fatigue Testing of
                                  Metallic Implant
                                  Materials.
8-121..........           8-564  ASTM F2005-21          Withdrawn and
                                  Standard Terminology   replaced with
                                  for Nickel-Titanium    newer version.
                                  Shape Memory Alloys.
8-193..........           8-565  ASTM F2754/F2754M-21   Withdrawn and
                                  Standard Test Method   replaced with
                                  for Measurement of     newer version.
                                  Camber Cast Helix
                                  and Direction of
                                  Helix of Coiled Wire.
8-346..........           8-566  ASTM F1813-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Wrought Titanium--12
                                  Molybdenum--6
                                  Zirconium--2 Iron
                                  Alloy for Surgical
                                  Implant (UNS R58120).
8-353..........           8-567  ASTM F86-21 Standard   Withdrawn and
                                  Practice for Surface   replaced with
                                  Preparation and        newer version.
                                  Marking of Metallic
                                  Surgical Implants.
8-355..........           8-568  ASTM F1586-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Wrought Nitrogen
                                  Strengthened 21
                                  Chromium-10 Nickel-3
                                  Manganese-2.5
                                  Molybdenum Stainless
                                  Steel Bar for
                                  Surgical Implants
                                  (UNS S31675).
8-385..........           8-569  ASTM F648-21 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Ultra-High-Molecular-  newer version.
                                  Weight Polyethylene
                                  Powder and
                                  Fabricated Form for
                                  Surgical Implants.
8-398..........           8-570  ASTM F1108-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Titanium-6Aluminum-
                                  4Vanadium Alloy
                                  Castings for
                                  Surgical Implants.
8-422..........           8-571  ASTM F2052-21          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Measurement of     newer version.
                                  Magnetically Induced
                                  Displacement Force
                                  on Medical Devices
                                  in the Magnetic
                                  Resonance
                                  Environment.
8-423..........           8-572  ASTM F2565-21          Withdrawn and
                                  Standard Guide for     replaced with
                                  Extensively            newer version.
                                  Irradiation-
                                  Crosslinked Ultra-
                                  High Molecular
                                  Weight Polyethylene
                                  Fabricated Forms for
                                  Surgical Implant
                                  Applications.
8-424..........           8-573  ASTM F2695-12(2020)    Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Ultra-High Molecular
                                  Weight Polyethylene
                                  Powder Blended With
                                  Alpha-Tocopherol
                                  (Vitamin E) and
                                  Fabricated Forms for
                                  Surgical Implant
                                  Applications.

[[Page 24178]]

 
8-425..........           8-574  ASTM F2820-12(2021)e1  Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Polyetherketoneketon
                                  e (PEKK) Polymers
                                  for Surgical Implant
                                  Applications.
8-443..........           8-575  ASTM F3160-21          Withdrawn and
                                  Standard Guide for     replaced with
                                  Metallurgical          newer version.
                                  Characterization of
                                  Absorbable Metallic
                                  Materials for
                                  Medical Implants.
8-450..........           8-576  ASTM F451-21 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Acrylic Bone Cement.   newer version.
8-456..........           8-577  ISO 13179-1 Second     Withdrawn and
                                  Edition 2021-09        replaced with
                                  Implants for           newer version.
                                  surgery--Coatings on   Title change.
                                  metallic surgical
                                  implants--Part 1:
                                  Plasma-sprayed
                                  coatings derived
                                  from titanium or
                                  titanium-6 aluminum-
                                  4 vanadium alloy
                                  powders.
8-460..........           8-578  ASTM F2848-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Medical-Grade Ultra-
                                  High-Molecular-
                                  Weight Polyethylene
                                  Yarns.
8-515..........           8-579  ISO 13779-3 Second     Withdrawn and
                                  Edition 2018-12        replaced with
                                  Implants for           newer version.
                                  surgery--Hydroxyapat
                                  ite--Part 3:
                                  Chemical analysis
                                  and characterization
                                  of crystallinity
                                  ratio and phase
                                  purity [Including
                                  AMENDMENT 1 (2021)].
------------------------------------------------------------------------
                            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
------------------------------------------------------------------------
10-73..........          10-127  ANSI Z80.21-2020       Withdrawn and
                                  American National      replaced with
                                  Standard for           newer version.
                                  Ophthalmics--Instrum
                                  ents--General-
                                  Purpose Clinical
                                  Visual Acuity Charts.
10-87..........          10-128  ASTM D882-18 Standard  Withdrawn and
                                  Test Method for        replaced with
                                  Tensile Properties     newer version.
                                  of Thin Plastic
                                  Sheeting.
10-88..........          10-129  ASTM D790-17 Standard  Withdrawn and
                                  Test Methods for       replaced with
                                  Flexural Properties    newer version.
                                  of Unreinforced and
                                  Reinforced Plastics
                                  and Electrical
                                  Insulating Materials.
10-102.........          10-130  ANSI Z80.36-2021       Withdrawn and
                                  American National      replaced with
                                  Standard for           newer version.
                                  Ophthalmics--Light
                                  Hazard Protection
                                  for Ophthalmic
                                  Instruments.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-239.........          11-385  ASTM F2345-21          Withdrawn and
                                  Standard Test          replaced with
                                  Methods for            newer version.
                                  Determination of
                                  Cyclic Fatigue
                                  Strength of Ceramic
                                  Modular Femoral
                                  Heads.
11-266.........          11-386  ASTM F2665-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Total Ankle
                                  Replacement
                                  Prosthesis.
11-305.........          11-387  ASTM F1781-21          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Elastomeric Flexible
                                  Hinge Finger Total
                                  Joint Implants.
11-345.........          11-388  ASTM F1717-21          Withdrawn and
                                  Standard Test          replaced with
                                  Methods for Spinal     newer version.
                                  Implant Constructs
                                  in a Vertebrectomy
                                  Model.
11-359.........          11-389  ISO 7206-10 Second     Withdrawn and
                                  edition 2018-08        replaced with
                                  Implants for           newer version.
                                  surgery--Partial and
                                  total hip-joint
                                  prostheses--Part 10:
                                  Determination of
                                  resistance to static
                                  load of modular
                                  femoral heads
                                  [Including AMENDMENT
                                  1 (2021)].
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-299.........          12-341  IEC 62563-1 Edition    Withdrawn and
                                  1.2 2021-07            replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Medical
                                  image display
                                  systems--Part 1:
                                  Evaluation methods.
12-300.........          12-342  NEMA DICOM PS 3.1--    Withdrawn and
                                  3.20 2021e Digital     replaced with
                                  Imaging and            newer version.
                                  Communications in
                                  Medicine (DICOM) Set.
------------------------------------------------------------------------

[[Page 24179]]

 
                         Q. Software/Informatics
------------------------------------------------------------------------
13-46..........  ..............  ASTM F2761-09 (2013)   Withdrawn. See
                                  Medical Devices and    13-120.
                                  Medical Systems--
                                  Essential safety
                                  requirements for
                                  equipment comprising
                                  the patient-centric
                                  integrated clinical
                                  environment (ICE)--
                                  Part 1: General
                                  requirements and
                                  conceptual model.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-424.........          14-563  ISO 13408-6 Second     Withdrawn and
                                  edition 2021-04        replaced with
                                  Aseptic processing     newer version.
                                  of health care
                                  products--Part 6:
                                  Isolator systems.
14-555.........          14-564  USP-NF M98910_01_01    Withdrawn and
                                  <161> Medical          replaced with
                                  Devices-Bacterial      newer version.
                                  Endotoxin and
                                  Pyrogen Tests.
14-556.........          14-565  USP-NF M98802_01_01    Withdrawn and
                                  <62> Microbiological   replaced with
                                  Examination of         newer version.
                                  Nonsterile Products:
                                  Tests for Specified
                                  Microorganisms.
14-557.........          14-566  USP-NF M98795_02_01    Withdrawn and
                                  <55> Biological        replaced with
                                  Indicators--Resistan   newer version.
                                  ce Performance Tests.
14-558.........          14-567  USP-NF M7414_01_01     Withdrawn and
                                  <1229.5> Biological    replaced with
                                  Indicators for         newer version.
                                  Sterilization.
14-559.........          14-568  USP-NF M98800_01_01    Withdrawn and
                                  <61> Microbiological   replaced with
                                  Examination of         newer version.
                                  Nonsterile Products:
                                  Microbial
                                  Enumeration Tests.
14-560.........          14-569  USP-NF M98810_01_01    Withdrawn and
                                  <71> Sterility Tests.  replaced with
                                                         newer version.
14-561.........          14-570  USP-NF M98830_02_01    Withdrawn and
                                  <85> Bacterial         replaced with
                                  Endotoxins Test.       newer version.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
15-29..........  ..............  ASTM F2259-10          Withdrawn.
                                  (Reapproved 2012)e1
                                  Standard Test Method
                                  for Determining the
                                  Chemical Composition
                                  and Sequence in
                                  Alginate by Proton
                                  Nuclear Magnetic
                                  Resonance (1H NMR)
                                  Spectroscopy.
------------------------------------------------------------------------
\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: 057. These entries are of standards not 
previously recognized by FDA.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                     Reference No. and
   Recognition No.        Title of standard \1\             date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-176................  Cardiovascular implants     ISO 18193 First
                        and artificial organs--     edition 2021-08.
                        Cannulae for
                        extracorporeal
                        circulation.
3-177................  Standard Guide for Three-   ASTM F2606-08
                        Point Bending of Balloon-   (Reapproved 2021).
                        Expandable Vascular
                        Stents and Stent Systems.
3-178................  Standard Guide for Radial   ASTM F3067-14
                        Loading of Balloon-         (Reapproved 2021).
                        Expandable and Self-
                        Expanding Vascular Stents.
3-179................  Standard Guide for Design   ASTM F3172-15
                        Verification Device Size    (Reapproved 2021).
                        and Sample Size Selection
                        for Endovascular Devices.
3-180................  Standard Test Method for    ASTM F3505-21.
                        Stent and Endovascular
                        Prosthesis Kink
                        Resistance.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-285................  Dental Abrasive Powders...  ANSI/ADA Standard No.
                                                    37--1986 (R2020).
4-286................  Dental Impression Trays...  ANSI/ADA Standard No.
                                                    87--1995 (R2014).

[[Page 24180]]

 
4-287................  Oral Rinses (Modified       ANSI/ADA Standard No.
                        adoption of ISO             116--2020.
                        16408:2015, Dentistry
                        Oral Care Products--Oral
                        Rinses).
4-288................  Dentistry--Mixing machines  ISO 7488 Second
                        for dental amalgam.         edition 2018-04.
4-289................  Dentistry--Intraoral        ISO 18556 First
                        spatulas.                   edition 2016-04.
4-290................  Dentistry--Integrated       ISO 28158 Second
                        dental floss and handles.   edition 2018-09.
4-291................  Dentistry--Products for     ISO 28399 First
                        external tooth bleaching.   edition 2011-01.
4-292................  Dentistry--Screening        ISO 28888 First
                        method for erosion          edition 2013-10.
                        potential of oral rinses
                        on dental hard tissues.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-42................  Electrical equipment for    IEC 61326-1 Edition
                        measurement, control and    3.0 2020-10.
                        laboratory use--EMC
                        requirements--Part 1:
                        General requirements.
19-43................  Electrical equipment for    IEC 61326-2-6 Edition
                        measurement, control and    3.0 2020-10.
                        laboratory use--EMC
                        requirements--Part 2-6:
                        Particular requirements--
                        In vitro diagnostic (IVD)
                        medical equipment.
19-44................  American National           ANSI/IEEE C63.24-
                        Standard--Recommended       2021.
                        Practice for In Situ RF
                        Immunity Evaluation of
                        Electronic Devices and
                        Systems.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-474................  Standard Specification for  ASTM F3352-19.
                        Isolation Gowns Intended
                        for Use in Healthcare
                        Facilities.
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-309................  Radiological protection--   ISO 17099 First
                        Performance criteria for    edition 2014-11-15.
                        laboratories using the
                        cytokinesis block
                        micronucleus (CBMN) assay
                        in peripheral blood
                        lymphocytes for
                        biological dosimetry.
7-310................  Radiological protection--   ISO 19238 Second
                        Performance criteria for    edition 2014-02-01.
                        service laboratories
                        performing biological
                        dosimetry by cytogenetics.
7-311................  A Hierarchical Approach to  CLSI EP39, 1st
                        Selecting Surrogate         Edition
                        Samples for the
                        Evaluation of In Vitro
                        Medical Laboratory Tests.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-580................  Eyewear display--Part 20-   IEC 63145-20-10
                        10: Fundamental             Edition 1.0 2019-08.
                        measurement methods--
                        Optical properties.
8-581................  Eyewear display--Part 20-   IEC 63145-20-20
                        20: Fundamental             Edition 1.0 2019-09.
                        measurement methods--
                        Image quality.
8-582................  Eyewear display--Part 22-   IEC 63145-22-10
                        10: Specific measurement    Edition 1.0 2020-01.
                        methods for AR type--
                        Optical properties.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-19................  Nanotechnologies--Measurem  ISO 19749 First
                        ents of particle size and   edition 2021-07.
                        shape distributions by
                        scanning electron
                        microscopy.
18-20................  Standard Guide for          ASTM E3275-21.
                        Visualization and
                        Identification of
                        Nanomaterials in
                        Biological and
                        Nonbiological Matrices
                        Using Darkfield
                        Microscopy/Hyperspectral
                        Imaging (DFM/HSI)
                        Analysis.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-390...............  Implants for surgery--Pre-  ISO 23089-2 First
                        clinical mechanical         edition 2021-05.
                        assessment of spinal
                        implants and particular
                        requirements--Part 2:
                        Spinal intervertebral
                        body fusion devices.
11-391...............  Standard Practice for       ASTM F2722-21.
                        Evaluating Mobile Bearing
                        Knee Tibial Baseplate
                        Rotational Stops.
11-392...............  Standard Test Method for    ASTM F2723-21.
                        Evaluating Mobile Bearing
                        Knee Tibial Baseplate/
                        Bearing Resistance to
                        Dynamic Disassociation.

[[Page 24181]]

 
11-393...............  Standard Test Method for    ASTM F2724-21.
                        Evaluating Mobile Bearing
                        Knee Dislocation.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-232...............  Medical electrical          IEC 80601-2-78
                        equipment--Part 2-78:       Edition 1.0 2019-07.
                        Particular requirements
                        for basic safety and
                        essential performance of
                        medical robots for
                        rehabilitation,
                        assessment, compensation
                        or alleviation.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-120...............  Medical Devices and         ANSI/AAMI 2700-
                        Medical Systems--           1:2019.
                        Essential safety
                        requirements for
                        equipment comprising the
                        patient-centric
                        integrated clinical
                        environment (ICE)--Part
                        1: General requirements
                        and conceptual model.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-571...............  Sterilization of health     ISO 11138-8 First
                        care products--Biological   edition 2021-07.
                        indicators--Part 8:
                        Method for validation of
                        a reduced incubation time
                        for a biological
                        indicator.
------------------------------------------------------------------------
                          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 
<a href="/cdn-cgi/l/email-protection#c38087918b90b7a2ada7a2b1a7b090b7a2a5a583a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="8ecdcadcc6ddfaefe0eaeffceafdddfaefe8e8cee8eaefa0e6e6fda0e9e1f8">[email protected]</span></a>. 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: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08571 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P


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