[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Notices]
[Pages 15202-15208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04376]


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

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: 061

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: 061'' (Recognition List Number: 061), 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 March 1, 2024.

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

Electronic Submissions

    Submit electronic comments in the following way:
    <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

[[Page 15203]]

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: 061.'' 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: 061.
    <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: 061 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: 
061 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: 061'' to Terry Woods, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Silver Spring, MD 20993, 301-796-2503. Send one self-addressed 
adhesive label to assist that office in processing your request or fax 
your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT: Terry Woods, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-2503, 
<a href="/cdn-cgi/l/email-protection#1c5f584e544f687d72787d6e786f4f687d7a7a5c7a787d3274746f327b736a"><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 
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: 061

    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: 061'' 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

[[Page 15204]]

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: 061.

       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
                    Replacement
 Old recognition    recognition  Title of standard \1\       Change
       No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-73.............         1-162  ISO 10651-4 Second     Withdrawn and
                                  edition 2023-03 Lung   replaced with
                                  ventilators--Part 4:   newer version.
                                  Particular
                                  requirements for
                                  user-powered
                                  resuscitators.
1-105............         1-163  ISO 80601-2-72 Second  Withdrawn and
                                  edition 2023-06        replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  72: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of home
                                  healthcare
                                  environment
                                  ventilators for
                                  ventilator-dependent
                                  patients.
1-118............         1-164  ISO 5361 Fourth        Withdrawn and
                                  edition 2023-11        replaced with
                                  Anaesthetic and        newer version.
                                  respiratory
                                  equipment--Tracheal
                                  tubes and connectors.
1-141............         1-165  ISO 80601-2-13 Second  Withdrawn and
                                  edition 2022-04        replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  13: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of an
                                  anaesthetic
                                  workstation.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-94.............         2-302  ASTM F981-23 Standard  Withdrawn and
                                  Practice for           replaced with
                                  Assessment of Muscle   newer version.
                                  and Bone Tissue
                                  Responses to Long-
                                  Term Implantable
                                  Materials Used in
                                  Medical Devices.
2-237............         2-303  ISO 10993-17 Second    Withdrawn and
                                  edition 2023-09        replaced with
                                  Biological             newer version.
                                  evaluation of
                                  medical devices--
                                  Part 17:
                                  Toxicological risk
                                  assessment of
                                  medical device
                                  constituents.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-105............  ............  IEC 60601-2-25         Extent of
                                  Edition 2.0 2011-10    recognition.
                                  Medical electrical
                                  equipment--Part 2-
                                  25: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  electrocardiographs.
3-126............  ............  IEC 60601-2-27         Extent of
                                  Edition 3.0 2011-03    recognition.
                                  Medical electrical
                                  equipment--Part 2-
                                  27: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  electrocardiographic
                                  monitoring equipment
                                  [Including:
                                  Corrigendum 1
                                  (2012)].
3-138............         3-189  ASTM F2942-19          Withdrawn and
                                  Standard Guide for     replaced with
                                  in vitro Axial,        newer version.
                                  Bending, and
                                  Torsional Durability
                                  Testing of Vascular
                                  Stents.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-137............         4-309  ISO 6877 Third         Withdrawn and
                                  edition 2021-09        replaced with
                                  Dentistry--Endodonti   newer version.
                                  c obturating
                                  materials.
4-151............         4-310  ISO 22112 Second       Withdrawn and
                                  edition 2017-08        replaced with
                                  Dentistry--Artificia   newer version.
                                  l teeth for dental
                                  prostheses.
4-188............         4-311  ISO 9917-2 Third       Withdrawn and
                                  edition 2017-09        replaced with
                                  Dentistry--Water-      newer version.
                                  based cements--Part
                                  2: Resin-modified
                                  cements.
4-190............         4-312  ANSI/ASA S3.35-2021    Withdrawn and
                                  American National      replaced with
                                  Standard Method for    newer version.
                                  Method of
                                  Measurement of
                                  Performance
                                  Characteristics of
                                  Hearing Aids Under
                                  Simulated Real-Ear
                                  Working Conditions.
4-218............         4-313  ISO 27020 Second       Withdrawn and
                                  edition 2019-06        replaced with
                                  Dentistry--Brackets    newer version.
                                  and tubes for use in
                                  orthodontics.
4-221............         4-314  ISO 7494-2 Third       Withdrawn and
                                  edition 2022-07        replaced with
                                  Dentistry--Stationar   newer version.
                                  y dental units and
                                  dental patient
                                  chairs--Part 2: Air,
                                  water, suction and
                                  wastewater systems.
4-224............         4-315  ISO 24234 Third        Withdrawn and
                                  edition 2021-08        replaced with
                                  Dentistry--Dental      newer version.
                                  Amalgam.
4-238............         4-316  ISO 20127 Second       Withdrawn and
                                  edition 2020-08        replaced with
                                  Dentistry--Physical    newer version.
                                  properties of
                                  powered toothbrushes.
4-244............         4-317  ISO 8325 Third         Withdrawn and
                                  edition 2023-03        replaced with
                                  Dentistry--Test        newer version.
                                  methods for rotary
                                  instruments.
4-246............         4-318  ISO 20749 Second       Withdrawn and
                                  edition 2023-06        replaced with
                                  Dentistry--Pre-        newer version.
                                  capsulated dental
                                  amalgam.
4-257............         4-319  ISO 17730 Second       Withdrawn and
                                  edition 2020-09        replaced with
                                  Dentistry--Fluoride    newer version.
                                  varnishes.
4-280............  ............  ANSI/ADA Standard No.  Withdrawn with
                                  117-2018 Fluoride      transition. See
                                  varnishes.             4-319.
------------------------------------------------------------------------

[[Page 15205]]

 
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-338............         6-497  ASTM D7866-23          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Radiation
                                  Attenuating
                                  Protective Gloves.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-235............         7-318  CLSI EP25 2nd Edition  Withdrawn and
                                  Evaluation of          replaced with
                                  Stability of In        newer version.
                                  Vitro Medical
                                  Laboratory Test
                                  Reagents.
7-304............         7-319  CLSI M23 6th Edition   Withdrawn and
                                  Development of In      replaced with
                                  Vitro Susceptibility   newer version.
                                  Test Methods,
                                  Breakpoints, and
                                  Quality Control
                                  Parameters.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-171............         8-605  ASTM F1609-23          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Calcium Phosphate
                                  Coatings for
                                  Implantable
                                  Materials.
8-412............         8-606  ASTM F2537-23          Withdrawn and
                                  Standard Practice      replaced with
                                  for Calibration of     newer version.
                                  Linear Displacement
                                  Sensor Systems Used
                                  to Measure
                                  Micromotion.
8-437............         8-607  ASTM F2082/F2082M-23   Withdrawn and
                                  Determination of       replaced with
                                  Transformation         newer version.
                                  Temperature of
                                  Nickel-Titanium
                                  Shape Memory Alloys
                                  by Bend and Free
                                  Recovery.
8-451............         8-608  ASTM F2214-2023        Withdrawn and
                                  Standard Test Method   replaced with
                                  for In Situ            newer version.
                                  Determination of
                                  Network Parameters
                                  of Crosslinked Ultra
                                  High Molecular
                                  Weight Polyethylene
                                  (UHMWPE).
8-475............         8-609  ASTM F2026-23          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Polyetheretherketone
                                  (PEEK) Polymers for
                                  Surgical Implant
                                  Applications.
8-483............         8-610  ASTM F601-23 Standard  Withdrawn and
                                  Practice for           replaced with
                                  Fluorescent            newer version.
                                  Penetrant Inspection
                                  of Metallic Surgical
                                  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
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-83............  ............  ISO 13402 First        Transferred. See
                                  edition 1995-08-01     4-320.
                                  Surgical and dental
                                  hand instruments--
                                  Determination of
                                  resistance against
                                  autoclaving,
                                  corrosion and
                                  thermal exposure.
11-276...........        11-402  ASTM F1798-21          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Evaluating the     newer version.
                                  Static and Fatigue
                                  Properties of
                                  Interconnection
                                  Mechanisms and
                                  Subassemblies Used
                                  in Spinal
                                  Arthrodesis Implants.
11-281...........  ............  ASTM F1672-14          Withdrawn with
                                  (Reapproved 2019)      transition. See
                                  Standard               11-400.
                                  Specification for
                                  Resurfacing Patellar
                                  Prosthesis.
11-299...........  ............  ASTM F2068-15          Withdrawn with
                                  Standard               transition. See
                                  Specification for      11-401.
                                  Femoral Prostheses--
                                  Metallic Implants.
11-301...........  ............  ASTM F2091-15          Withdrawn with
                                  Standard               transition. See
                                  Specification for      11-401.
                                  Acetabular
                                  Prostheses.
11-303...........        11-403  ASTM F3047M-23         Withdrawn and
                                  Standard Guide for     replaced with
                                  High Demand Hip        newer version.
                                  Simulator Wear
                                  Testing of Hard-on-
                                  Hard Articulations.
11-321...........        11-404  ASTM F2887-23          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Total Elbow
                                  Prostheses.

[[Page 15206]]

 
11-334...........        11-405  ASTM F1829-23          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Static             newer version.
                                  Evaluation of
                                  Anatomic Glenoid
                                  Locking Mechanism in
                                  Shear.
11-335...........        11-406  ASTM F3141-23          Withdrawn and
                                  Standard Guide for     replaced with
                                  Total Knee             newer version.
                                  Replacement Loading
                                  Profiles.
11-341...........        11-407  ASTM F3140-23          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Cyclic Fatigue     newer version.
                                  Testing of Metal
                                  Tibial Tray
                                  Components of
                                  Unicondylar Knee
                                  Joint Replacements.
11-377...........  ............  ASTM F2083-21          Withdrawn with
                                  Standard               transition. See
                                  Specification for      11-400.
                                  Knee Replacement
                                  Prosthesis.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-348...........  ............  IEC 60601-2-54         Extent of
                                  Edition 2.0 2022-09    recognition.
                                  Medical electrical
                                  equipment--Part 2-
                                  54: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of X-ray
                                  equipment for
                                  radiography and
                                  radioscopy.
12-349...........        12-352  NEMA PS 3.1-3.20       Withdrawn and
                                  2023e Digital          replaced with
                                  Imaging and            newer version.
                                  Communications in
                                  Medicine (DICOM) set.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-141...........        14-589  ISO 14644-4 Second     Withdrawn and
                                  edition 2022-11        replaced with
                                  Cleanrooms and         newer version.
                                  associated
                                  controlled
                                  environments--Part
                                  4: Design,
                                  construction and
                                  start-up.
14-379...........        14-590  ISO 14644-8 Third      Withdrawn and
                                  edition 2022-06        replaced with
                                  Cleanrooms and         newer version.
                                  associated
                                  controlled
                                  environments--Part
                                  8: Assessment of air
                                  cleanliness by
                                  chemical
                                  concentration (ACC).
14-390...........        14-591  ISO 14644-10 Second    Withdrawn and
                                  edition 2022-05        replaced with
                                  Cleanrooms and         newer version.
                                  associated
                                  controlled
                                  environments--Part
                                  10: Assessment of
                                  surface cleanliness
                                  for chemical
                                  contamination.
14-427...........        14-592  ISO 13408-1 Third      Withdrawn and
                                  edition 2023-08        replaced with
                                  Aseptic processing     newer version.
                                  of health care
                                  products--Part 1:
                                  General requirements.
14-516...........        14-593  ASTM F3039-23          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Detecting Leaks    newer version.
                                  in Nonporous
                                  Packaging or
                                  Flexible Barrier
                                  Materials by Dye
                                  Penetration.
14-530...........        14-594  ISO 11607-1 Second     Withdrawn and
                                  edition 2019-02        replaced with
                                  [Including             newer version.
                                  ADM1:2023] Packaging
                                  for terminally
                                  sterilized medical
                                  devices--Part 1:
                                  Requirements for
                                  materials, sterile
                                  barrier systems and
                                  packaging systems
                                  [Including Amendment
                                  1 (2023)].
14-531...........        14-595  ISO 11607-2 Second     Withdrawn and
                                  edition 2019-02        replaced with
                                  [Including             newer version.
                                  AMD1:2023] Packaging
                                  for terminally
                                  sterilized medical
                                  devices--Part 2:
                                  Validation
                                  requirements for
                                  forming, sealing and
                                  assembly processes
                                  [Including Amendment
                                  1 (2023)].
14-573...........        14-596  ASTM F88/F88M-23       Withdrawn and
                                  Standard Test Method   replaced with
                                  for Seal Strength of   newer version.
                                  Flexible Barrier
                                  Materials.
------------------------------------------------------------------------
                          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: 061. 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
------------------------------------------------------------------------
1-166....................  Gas mixers for medical    ISO 11195 Second
                            use--Stand-alone gas      edition 2018-01.
                            mixers..
------------------------------------------------------------------------

[[Page 15207]]

 
                           B. Biocompatibility
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-190....................  Sizing parameters of      ISO/PAS 7020 First
                            surgical valve            edition 2023-05.
                            prostheses:
                            Requirements regarding
                            the application of ISO
                            5840-2.
------------------------------------------------------------------------
                              D. Dental/ENT
------------------------------------------------------------------------
4-320....................  Surgical and dental and   ISO 13402 First
                            instruments--Determinat   edition 1995-08.
                            ion of resistance
                            against autoclaving,
                            corrosion and thermal
                            exposure.
4-321....................  Dentistry--Intraoral      ISO 23450 First
                            camera.                   edition 2021-03.
4-322....................  Dentistry--Machinable     ISO 18675 First
                            ceramic blanks.           edition 2022-05.
4-323....................  Dentistry--Polymer-based  ISO 5139 First
                            composite machinable      edition 2023-05.
                            blanks.
4-324....................  Dentistry--Polymer-based  ISO/TS 16506 First
                            luting materials          edition 2018-03.
                            containing adhesive
                            components.
------------------------------------------------------------------------
                          E. General I (QS/RM)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         F. General II (ES/EMC)
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                G. GH/GPS
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                                 H. IVD
------------------------------------------------------------------------
7-320....................  Validation of Assays      CLSI H62 1st
                            Performed by Flow         Edition.
                            Cytometry.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
18-24....................  Standard Test Method for  ASTM E2524-22.
                            Analysis of Hemolytic
                            Properties of
                            Nanoparticles.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                           L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-150....................  Copper-bearing            ISO 7439 Fourth
                            contraceptive             edition 2023-04.
                            intrauterine devices--
                            Requirements and tests.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                             N. OrthopedicX
------------------------------------------------------------------------
11-400...................  Non-active surgical       ISO 21536 Third
                            implants--Joint           edition 2023-07.
                            replacement implants--
                            Specific requirements
                            for knee-joint
                            replacement implants.
11-401...................  Non-active surgical       ISO 21535 Third
                            implants--Joint           edition 2023-07.
                            replacement implants--
                            Specific requirements
                            for hip-joint
                            replacement implants.
11-408...................  Standard Test Method for  ASTM F2777-23.
                            Evaluating Knee Bearing
                            (Tibial Insert)
                            Endurance and
                            Deformation Under High
                            Flexion.
11-409...................  Standard Test Methods     ASTM F3495-23.
                            for Determining the
                            Static Failure Load of
                            Ceramic Knee Femoral
                            Components.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
12-353...................  American National         ANSI Z136.1-2022.
                            Standard for Safe Use
                            of Lasers.
------------------------------------------------------------------------

[[Page 15208]]

 
                         Q. Software/Informatics
------------------------------------------------------------------------
13-129...................  Software and systems      ISO/IEC/IEEE 29119-
                            engineering--Software     1 Second edition
                            testing--Part 1:          2022-01.
                            General concepts.
13-130...................  Medical devices and       ANSI/AAMI 2700-2-
                            medical systems--         1:2022.
                            Essential safety and
                            performance
                            requirements for
                            equipment comprising
                            the patient-centric
                            integrated clinical
                            environment (ICE): Part
                            2-1: Particular
                            requirements for
                            forensic data logging.
13-131...................  Standard for medical      ANSI/AAMI
                            device security--         SW96:2023.
                            Security risk
                            management for device
                            manufacturers.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-597...................  Water Quality for         ANSI/AAMI
                            Processing Medical        ST108:2023.
                            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 
<a href="/cdn-cgi/l/email-protection#632027312b3017020d07021107103017020505230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="e9aaadbba1ba9d88878d889b8d9aba9d888f8fa98f8d88c781819ac78e869f">[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: February 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04376 Filed 2-29-24; 8:45 am]
BILLING CODE 4164-01-P


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