[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22678-22686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08992]


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

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: 055

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: 055'' (Recognition List Number: 055), 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 29, 2021.

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

Electronic Submissions

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

[[Page 22679]]

written/paper submission and in the manner detailed (see ``Written/
Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 055.'' 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: 055.
     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: 055 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: 
055 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: 055'' 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, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 
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 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: 055

    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: 055'' 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: 055.

[[Page 22680]]



       Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
      Old          Replacement
  recognition      recognition   Title of standard \1\       Change
      No.              No.
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-79...........           1-147  ISO 26825 Second       Withdrawn and
                                  edition 2020-10        replaced with
                                  Anaesthetic and        newer version.
                                  respiratory
                                  equipment--User-
                                  applied labels for
                                  syringes containing
                                  drugs used during
                                  anaesthesia--Colours
                                  , design and
                                  performance.
1-102..........           1-148  ISO 80601-2-69 Second  Withdrawn and
                                  edition 2020-11        replaced with
                                  Medical electrical     newer version.
                                  equipment--Part 2-
                                  69: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  oxygen concentrator
                                  equipment.
1-123..........           1-149  ISO 7376 Third         Withdrawn and
                                  edition 2020-08        replaced with
                                  Anaesthetic and        newer version.
                                  respiratory
                                  equipment--Laryngosc
                                  opes for tracheal
                                  intubation.
1-125..........           1-150  ISO 8836 Fifth         Withdrawn and
                                  edition 2019-12        replaced with
                                  Suction catheters      newer version.
                                  for use in the
                                  respiratory tract.
1-146..........  ..............  ISO 80601-2-12 Second  Transition
                                  edition 2020-02        period
                                  Medical electrical     extended.
                                  equipment--Part 2-
                                  12: Particular
                                  requirements for
                                  basic safety and
                                  essential
                                  performance of
                                  critical care
                                  ventilators.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-119..........           2-277  ASTM F813-20 Standard  Withdrawn and
                                  Practice for Direct    replaced with
                                  Contact Cell Culture   newer version.
                                  Evaluation of
                                  Materials for
                                  Medical Devices.
2-122..........           2-278  ASTM F719-20 [egr]1    Withdrawn and
                                  Standard Practice      replaced with
                                  for Testing            newer version.
                                  Materials in Rabbits
                                  for Primary Skin
                                  Irritation.
2-124..........           2-279  ASTM F750-20 Standard  Withdrawn and
                                  Practice for           replaced with
                                  Evaluating Acute       newer version.
                                  Systemic Toxicity of
                                  Material Extracts by
                                  Systemic Injection
                                  in the Mouse.
2-133..........           2-280  ASTM F1408-20a         Withdrawn and
                                  Standard Practice      replaced with
                                  for Subcutaneous       newer version.
                                  Screening Test for
                                  Implant Materials.
2-167..........           2-281  ISO 10993-19 Second    Withdrawn and
                                  edition 2020-03        replaced with
                                  Biological             newer version.
                                  evaluation of
                                  medical devices--
                                  Part 19: Physico-
                                  chemical,
                                  morphological and
                                  topographical
                                  characterization of
                                  materials.
2-205..........           2-282  ISO 14155 Third        Withdrawn and
                                  edition 2020-07        replaced with
                                  Clinical               newer version.
                                  investigation of
                                  medical devices for
                                  human subjects--Good
                                  clinical practice.
2-214..........           2-283  ASTM F619-20 Standard  Withdrawn and
                                  Practice for           replaced with
                                  Extraction of          newer version.
                                  Materials Used in
                                  Medical Devices.
2-269..........           2-284  USP 43-NF38:2020 <87>  Withdrawn and
                                  Biological             replaced with
                                  Reactivity Test, In    newer version.
                                  Vitro--Direct
                                  Contact Test.
2-270..........           2-285  USP 43-NF38:2020 <87>  Withdrawn and
                                  Biological             replaced with
                                  Reactivity Test, In    newer version.
                                  Vitro--Elution Test.
2-271..........           2-286  USP 43-NF38:2020 <88>  Withdrawn and
                                  Biological             replaced with
                                  Reactivity Tests, In   newer version.
                                  Vivo.
2-272..........           2-287  USP 43-NF38:2020       Withdrawn and
                                  <151> Pyrogen Test     replaced with
                                  (USP Rabbit Test).     newer version.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-92...........           4-264  ANSI/ADA Standard No.  Withdrawn and
                                  88--2019 Dental        replaced with
                                  Brazing Alloys.        newer version.
4-243..........  ..............  ISO 10271 First        Withdrawn.
                                  edition 2001-06
                                  Dental metallic
                                  materials--Corrosion
                                  test methods.
4-245..........           4-265  ISO 10271 Third        Withdrawn and
                                  edition 2020-08        replaced with
                                  Dentistry--Corrosion   newer version.
                                  test methods for
                                  metallic materials.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-76...........           5-131  IEC 60601-1-8 Edition  Withdrawn and
                                  2.2 2020-07            replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-8:
                                  General requirements
                                  for basic safety and
                                  essential
                                  performance--Collate
                                  ral standard:
                                  General
                                  requirements, tests
                                  and guidance for
                                  alarm systems in
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  systems.
5-89...........           5-132  IEC 60601-1-6 Edition  Withdrawn and
                                  3.2 2020-07            replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-6:
                                  General requirements
                                  for basic safety and
                                  essential
                                  performance--Collate
                                  ral standard:
                                  Usability.
5-115..........           5-133  ISO 80369-7 Second     Withdrawn and
                                  edition 2021 Small-    replaced with
                                  bore connectors for    newer version.
                                  liquids and gases in
                                  healthcare
                                  applications--Part
                                  7: Connectors for
                                  intravascular or
                                  hypodermic
                                  applications.
------------------------------------------------------------------------

[[Page 22681]]

 
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-8...........           19-36  IEC 60601-1-2 Edition  Withdrawn and
                                  4.1 2020-09            replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-2:
                                  General requirements
                                  for basic safety and
                                  essential
                                  performance--Collate
                                  ral Standard:
                                  Electromagnetic
                                  disturbances--Requir
                                  ements and tests.
19-9...........           19-37  IEC 60601-1-10         Withdrawn and
                                  Edition 1.2 2020-07    replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-
                                  10: General
                                  requirements for
                                  basic safety and
                                  essential
                                  performance--Collate
                                  ral Standard:
                                  Requirements for the
                                  development of
                                  physiologic closed-
                                  loop controllers.
19-14..........           19-38  IEC 60601-1-11         Withdrawn and
                                  Edition 2.1 2020-07    replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-
                                  11: General
                                  requirements for
                                  basic safety and
                                  essential
                                  performance--Collate
                                  ral Standard:
                                  Requirements for
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  systems used in the
                                  home healthcare
                                  environment.
19-15..........           19-39  IEC 60601-1-12         Withdrawn and
                                  Edition 1.1 2020-07    replaced with
                                  CONSOLIDATED VERSION   newer version.
                                  Medical electrical
                                  equipment--Part 1-
                                  12: General
                                  requirements for
                                  basic safety and
                                  essential
                                  performance--Collate
                                  ral Standard:
                                  Requirements for
                                  medical electrical
                                  equipment and
                                  medical electrical
                                  systems intended for
                                  use in the emergency
                                  medical services
                                  environment.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-11...........  ..............  ISO 594-1 First        Withdrawn. See 5-
                                  edition 1986-06-15     133.
                                  Conical fittings
                                  with a 6% (Luer)
                                  taper for syringes,
                                  needles and certain
                                  other medical
                                  equipment--Part 1:
                                  General requirements.
6-129..........  ..............  ISO 594-2 Second       Withdrawn. See 5-
                                  edition 1998-09-01     133.
                                  Conical fittings
                                  with a 6% (Luer)
                                  taper for syringes,
                                  needles and certain
                                  other medical
                                  equipment--Part 2:
                                  Lock fittings.
6-180..........           6-448  ASTM F2407-20          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Surgical Gowns
                                  Intended for Use in
                                  Healthcare
                                  Facilities.
6-339..........           6-449  ASTM F1169-19          Withdrawn and
                                  Standard Consumer      replaced with
                                  Safety Specification   newer version.
                                  for Full-Size Baby
                                  Cribs.
6-340..........  ..............  ASTM F2710-13          Withdrawn.
                                  Standard Consumer
                                  Safety Performance
                                  Specification for
                                  Commercial Cribs.
6-387..........           6-450  IEC 60601-2-50 Ed.     Withdrawn and
                                  3.0 2020-09 Medical    replaced with
                                  electrical             newer version.
                                  equipment--Part 2-
                                  50: Particular
                                  requirements for the
                                  basic safety and
                                  essential
                                  performance of
                                  infant phototherapy
                                  equipment.
6-428..........           6-451  USP 43-NF38:2020       Withdrawn and
                                  Sodium Chloride        replaced with
                                  Irrigation.            newer version.
6-429..........           6-452  USP 43-NF38:2020       Withdrawn and
                                  Sodium Chloride        replaced with
                                  Injection.             newer version.
6-430..........           6-453  USP 43-NF38:2020       Withdrawn and
                                  Nonabsorbable          replaced with
                                  Surgical Suture.       newer version.
6-431..........           6-454  USP 43-NF38:2020       Withdrawn and
                                  <881> Tensile          replaced with
                                  Strength.              newer version.
6-432..........           6-455  USP 43-NF38:2020       Withdrawn and
                                  <861> Sutures--        replaced with
                                  Diameter.              newer version.
6-433..........           6-456  USP 43-NF38:2020       Withdrawn and
                                  <871> Sutures--        replaced with
                                  Needle Attachment.     newer version.
6-434..........           6-457  USP 43-NF38:2020       Withdrawn and
                                  Sterile Water for      replaced with
                                  Irrigation.            newer version.
6-435..........           6-458  USP 43-NF38:2020       Withdrawn and
                                  Heparin Lock Flush     replaced with
                                  Solution.              newer version.
6-436..........           6-459  USP 43-NF38:2020       Withdrawn and
                                  Absorbable Surgical    replaced with
                                  Suture.                newer version.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-101..........  ..............  CLSI H51-A Assays of   Withdrawn.
                                  von Willebrand
                                  Factor Antigen and
                                  Ristocetin Cofactor
                                  Activity; Approved
                                  Guideline.
7-112..........           7-299  CLSI POCT14 2nd        Withdrawn and
                                  Edition Point-of-      replaced with
                                  Care Coagulation       newer version.
                                  Testing and
                                  Anticoagulation
                                  Monitoring.
7-131..........  ..............  CLSI I/LA18-A2         Withdrawn.
                                  (Replaces I/LA18-A)
                                  Specifications for
                                  Immunological
                                  Testing for
                                  Infectious Diseases;
                                  Approved Guideline--
                                  Second Edition.
7-135..........  ..............  CLSI H44-A2 (Replaces  Withdrawn.
                                  H44-A) Methods for
                                  Reticulocyte
                                  Counting (Automated
                                  Blood Cell Counters,
                                  Flow Cytometry, and
                                  Supravital Dyes);
                                  Approved Guideline--
                                  Second Edition.
7-142..........  ..............  CLSI GP43-A4           Withdrawn.
                                  (Formerly H11-A4)
                                  Procedures for the
                                  Collection of
                                  Arterial Blood
                                  Specimens; Approved
                                  Standard--Fourth
                                  Edition.

[[Page 22682]]

 
7-146..........  ..............  CLSI M06-A2 Protocols  Withdrawn.
                                  for Evaluating
                                  Dehydrated Mueller-
                                  Hinton Agar;
                                  Approved Standard--
                                  Second Edition.
7-164..........  ..............  CLSI GP28-A (Replaces  Withdrawn.
                                  GP28-P) Microwave
                                  Device Use in the
                                  Histology
                                  Laboratory; Approved
                                  Guideline.
7-173..........  ..............  CLSI C44-A (Replaces   Withdrawn.
                                  C44-P) Harmonization
                                  of Glycohemoglobin
                                  Measurements;
                                  Approved Guideline.
7-191..........           7-300  CLSI MM13 2nd Edition  Withdrawn and
                                  Collection,            replaced with
                                  Transport,             newer version.
                                  Preparation, and
                                  Storage of Specimens
                                  for Molecular
                                  Methods.
7-203..........           7-301  CLSI GP42 7th Edition  Withdrawn and
                                  Collection of          replaced with
                                  Capillary Blood        newer version.
                                  Specimens.
7-211..........           7-302  CLSI C34 4th Edition   Withdrawn and
                                  Sweat Testing:         replaced with
                                  Specimen Collection    newer version.
                                  and Quantitative
                                  Chloride Analysis.
7-217..........           7-303  CLSI M60 2nd Edition   Withdrawn and
                                  Performance            replaced with
                                  Standards for          newer version.
                                  Antifungal
                                  Susceptibility
                                  Testing of Yeast.
7-261..........           7-304  CLSI M23 5th Edition   Withdrawn and
                                  Development of In      replaced with
                                  Vitro Susceptibility   newer version.
                                  Testing Criteria and
                                  Quality Control
                                  Parameters.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-217..........           8-537  ASTM F620-20 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Titanium Alloy         newer version.
                                  Forgings for
                                  Surgical Implants in
                                  the Alpha Plus Beta
                                  Condition.
8-223..........           8-538  ASTM F2759-19          Withdrawn and
                                  Standard Guide for     replaced with
                                  Assessment of the      newer version.
                                  Ultra-High Molecular
                                  Weight Polyethylene
                                  (UHMWPE) Used in
                                  Orthopedic and
                                  Spinal Devices.
8-338..........           8-539  ASTM F139-19 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Wrought 18Chromium-    newer version.
                                  14Nickel-
                                  2.5Molybdenum
                                  Stainless Steel
                                  Sheet and Strip for
                                  Surgical Implants
                                  (UNS S31673).
8-339..........           8-540  ASTM F1091-20          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Wrought Cobalt-
                                  20Chromium-
                                  15Tungsten-10Nickel
                                  Alloy Surgical
                                  Fixation Wire (UNS
                                  R30605).
8-342..........           8-541  ASTM F1537-20          Withdrawn and
                                  Standard               replaced with
                                  Specification for      newer version.
                                  Wrought Cobalt-
                                  28Chromium-
                                  6Molybdenum Alloys
                                  for Surgical
                                  Implants (UNS
                                  R31537, UNS R31538,
                                  and UNS R31539).
8-348..........           8-542  ASTM F138-19 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Wrought 18Chromium-    newer version.
                                  14Nickel-
                                  2.5Molybdenum
                                  Stainless Steel Bar
                                  and Wire for
                                  Surgical Implants
                                  (UNS S31673).
8-361..........           8-543  ASTM F755-19 Standard  Withdrawn and
                                  Specification for      replaced with
                                  Selection of Porous    newer version.
                                  Polyethylene for Use
                                  in Surgical Implants.
8-395..........           8-544  ASTM F961-20 Standard  Withdrawn and
                                  Specification for      replaced with
                                  35Cobalt-35Nickel-     newer version.
                                  20Chromium-
                                  10Molybdenum Alloy
                                  Forgings for
                                  Surgical Implants
                                  (UNS R30035).
8-416..........           8-545  ASTM F2977-20          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Small Punch        newer version.
                                  Testing of Polymeric
                                  Biomaterials Used in
                                  Surgical Implants.
8-417..........           8-546  ASTM F3044-20          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Evaluating the     newer version.
                                  Potential for
                                  Galvanic Corrosion
                                  for Medical Implants.
8-421..........           8-547  ASTM F629-20 Standard  Withdrawn and
                                  Practice for           replaced with
                                  Radiography of Cast    newer version.
                                  Metallic Surgical
                                  Implants.
8-438..........           8-548  ISO/ASTM 52915 Third   Withdrawn and
                                  edition 2020-03        replaced with
                                  Specification for      newer version.
                                  additive
                                  manufacturing file
                                  format (AMF) Version
                                  1.2.
8-530..........           8-549  ASTM F3208-20          Withdrawn and
                                  Standard Guide for     replaced with
                                  Selecting Test Soils   newer version.
                                  for Validation of
                                  Cleaning Methods for
                                  Reusable Medical
                                  Devices.
------------------------------------------------------------------------
                            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)
------------------------------------------------------------------------
9-40...........           9-130  ISO 8600-6: Second     Withdrawn and
                                  Edition 2020-09        replaced with
                                  Endoscopes--Medical    newer version.
                                  endoscopes and
                                  endotherapy devices--
                                  Part 6: Vocabulary.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
10-48..........          10-119  ISO 11979-5 Third      Withdrawn and
                                  edition 2020-09        replaced with
                                  Ophthalmic implants--  newer version.
                                  Intraocular Lenses--
                                  Part 5:
                                  Biocompatibility.

[[Page 22683]]

 
10-63..........          10-120  ISO/TR 22979 Second    Withdrawn and
                                  Edition 2017-05        replaced with
                                  Ophthalmic implants--  newer version.
                                  Intraocular Lenses--
                                  Guidance on
                                  assessment of the
                                  need for clinical
                                  investigation of
                                  intraocular lens
                                  design modifications.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-191.........          11-370  ISO 14879-1 Second     Withdrawn and
                                  edition 2020-07        replaced with
                                  Implants for           newer version.
                                  surgery--Total knee-
                                  joint prostheses--
                                  Part 1:
                                  Determination of
                                  endurance properties
                                  of knee tibial trays.
11-267.........          11-371  ASTM F2009-20          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Determining the    newer version.
                                  Axial Disassembly
                                  Force of Taper
                                  Connections of
                                  Modular Prostheses.
11-279.........          11-372  ASTM F2996-20          Withdrawn and
                                  Standard Practice      replaced with
                                  for Finite Element     newer version.
                                  Analysis (FEA) of
                                  Non-Modular Metallic
                                  Orthopaedic Hip
                                  Femoral Stems.
11-282.........          11-373  ASTM F1223-20          Withdrawn and
                                  Standard Test Method   replaced with
                                  for Determination of   newer version.
                                  Total Knee
                                  Replacement
                                  Constraint.
11-313.........          11-374  ISO 7207-2 Second      Withdrawn and
                                  edition 2011-07-01     replaced with
                                  Implants for           newer version.
                                  surgery--Components
                                  for partial and
                                  total knee joint
                                  prostheses--Part 2:
                                  Articulating
                                  surfaces made of
                                  metal, ceramic and
                                  plastics materials
                                  [Including AMENDMENT
                                  1 (2016) and
                                  AMENDMENT 2 (2020)].
11-330.........  ..............  ASTM F2028-17          Extent of
                                  Standard Test          recognition.
                                  Methods for Dynamic
                                  Evaluation of
                                  Glenoid Loosening or
                                  Disassociation.
11-332.........          11-375  ASTM F2193-20          Withdrawn and
                                  Standard               replaced with
                                  Specifications and     newer version.
                                  Test Methods for
                                  Components Used in
                                  the Surgical
                                  Fixation of the
                                  Spinal Skeletal
                                  System.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
                      No new entries at this time.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-314.........          14-550  ANSI/AAMI ST67:2019    Withdrawn and
                                  Sterilization of       replaced with
                                  health care            newer version.
                                  products--Requiremen
                                  ts and guidance for
                                  selecting a
                                  sterility assurance
                                  level (SAL) for
                                  products labeled
                                  ``sterile''.
14-361.........          14-551  ISO 14160 Third        Withdrawn and
                                  edition 2020-09        replaced with
                                  Sterilization of       newer version.
                                  health care
                                  products--Liquid
                                  chemical sterilizing
                                  agents for single-
                                  use medical devices
                                  utilizing animal
                                  tissues and their
                                  derivatives--Require
                                  ments for
                                  characterization,
                                  development,
                                  validation and
                                  routine control of a
                                  sterilization
                                  process for medical
                                  devices.
14-411.........          14-552  ISO/ASTM 51818 Fourth  Withdrawn and
                                  edition 2020-06        replaced with
                                  Practice for           newer version.
                                  dosimetry in an
                                  electron beam
                                  facility for
                                  radiation processing
                                  at energies between
                                  80 and 300 keV.
14-498.........          14-553  ASTM F2097-20          Withdrawn and
                                  Standard Guide for     replaced with
                                  Design and             newer version.
                                  Evaluation of
                                  Primary Flexible
                                  Packaging for
                                  Medical Products.
14-519.........          14-554  ASTM F17-20 Standard   Withdrawn and
                                  Terminology Relating   replaced with
                                  to Primary Barrier     newer version.
                                  Packaging.
14-534.........          14-555  USP 43-NF38:2020       Withdrawn and
                                  <161> Medical          replaced with
                                  Devices-Bacterial      newer version.
                                  Endotoxin and
                                  Pyrogen Tests.
14-535.........          14-556  USP 43-NF38:2020 <62>  Withdrawn and
                                  Microbiological        replaced with
                                  Examination of         newer version.
                                  Nonsterile Products:
                                  Tests for Specified
                                  Microorganisms.
14-536.........          14-557  USP 43-NF38:2020 <55>  Withdrawn and
                                  Biological             replaced with
                                  Indicators--Resistan   newer version.
                                  ce Performance Tests.
14-537.........          14-558  USP 43-NF38:2020       Withdrawn and
                                  <1229.5> Biological    replaced with
                                  Indicators for         newer version.
                                  Sterilization.
14-546.........          14-559  USP 43-NF38:2020 <61>  Withdrawn and
                                  Microbiological        replaced with
                                  Examination of         newer version.
                                  Nonsterile Products:
                                  Microbial
                                  Enumeration Tests.
14-547.........          14-560  USP 43-NF38:2020 <71>  Withdrawn and
                                  Sterility Tests.       replaced with
                                                         newer version.
14-548.........          14-561  USP 43-NF38:2020 <85>  Withdrawn and
                                  Bacterial Endotoxins   replaced with
                                  Test.                  newer version.
------------------------------------------------------------------------

[[Page 22684]]

 
                          S. Tissue Engineering
------------------------------------------------------------------------
15-35..........  ..............  ASTM F2900-11          Withdrawn.
                                  Standard Guide for
                                  Characterization of
                                  Hydrogels used in
                                  Regenerative
                                  Medicine.
15-36..........  ..............  ASTM F2383-11          Withdrawn.
                                  Standard Guide for
                                  Assessment of
                                  Adventitious Agents
                                  in Tissue Engineered
                                  Medical Products
                                  (TEMPs).
15-38..........  ..............  ASTM F2883-11          Withdrawn.
                                  Standard Guide for
                                  Characterization of
                                  Ceramic and Mineral
                                  Based Scaffolds used
                                  for Tissue-
                                  Engineered Medical
                                  Products (TEMPs) and
                                  as Device for
                                  Surgical Implant
                                  Applications.
15-45..........           15-64  ISO 22442-1 Third      Withdrawn and
                                  edition 2020-09        replaced with
                                  Medical devices        newer version.
                                  utilizing animal
                                  tissues and their
                                  derivatives--Part 1:
                                  Application of risk
                                  management.
15-46..........           15-65  ISO 22442-2 Third      Withdrawn and
                                  edition 2020-09        replaced with
                                  Medical devices        newer version.
                                  utilizing animal
                                  tissues and their
                                  derivatives--Part 2:
                                  Controls on
                                  sourcing, collection
                                  and handling.
------------------------------------------------------------------------
\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: 055. These entries are of standards not 
previously recognized by FDA.

                            Table 2--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
     Recognition  No.                      Title of standard \1\                      Reference No. and date
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-288.....................  Biological evaluation of medical devices--Part 15:   ISO 10993-15 Second edition
                             Identification and quantification of degradation     2019-11.
                             products from metals and alloys.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-169.....................  Medical electrical equipment--Part 2-4: Particular   IEC Edition 3.1 2018-02
                             requirements for the basic safety and essential      CONSOLIDATED VERSION.
                             performance of cardiac defibrillators.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-266.....................  Dentistry--Orthodontic anchor screws...............  ISO 19023 First edition 2018-
                                                                                  02.
4-267.....................  Dentistry--Elastomeric auxiliaries for use in        ISO 21606 First edition 2007-
                             orthodontics.                                        06.
4-268.....................  Dentistry--Wires for use in orthodontics [Including  ISO 15841 Second edition 2014-
                             AMENDMENT 1 (2020)].                                 08.
4-269.....................  Dentistry--Coupling dimensions for handpiece         ISO 3964 Third edition 11-2016.
                             connectors [Including AMENDMENT 1 (2018)].
4-270.....................  CAD/CAM Abutments in Dentistry.....................  ADA Technical Report No. 146-
                                                                                  2018.
4-271.....................  Dental Cartridge Syringes..........................  ANSI/ADA Standard No. 34-2013.
4-272.....................  Root Canal Barbed Broaches and Rasps...............  ANSI/ADA Standard No. 63-2013.
----------------------------------------------------------------------------------------------------------------
                             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)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-305.....................  In vitro diagnostic medical devices--Requirements    ISO 17511 Second edition 2020-
                             for establishing metrological traceability of        04.
                             values assigned to calibrators, trueness control
                             materials and human samples..
----------------------------------------------------------------------------------------------------------------

[[Page 22685]]

 
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-550.....................  Standard Specification for Wrought Seamless          ASTM F2181-20.
                             Stainless Steel Tubing for Surgical Implants.
8-551.....................  Standard Practice for Digital Radiography of Cast    ASTM F2895-20.
                             Metallic Implants.
8-552.....................  Guide for Additive manufacturing--Installation/      ASTM F3434-20.
                             Operation and Performance Qualification (IQ/OQ/PQ)
                             of Laser-Beam Powder Bed Fusion Equipment for
                             Production Manufacturing New publication.
8-553.....................  Additive manufacturing--Material extrusion-based     ISO/ASTM 52903-1 First edition
                             additive manufacturing of plastic materials--Part    2020-04.
                             1: Feedstock materials.
8-554.....................  Additive manufacturing--Design--Functionally graded  ISO/ASTM TR 52912 First edition
                             additive manufacturing.                              2020-09.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-17.....................  Nanotechnologies--Measurements of particle size and  ISO 21363 First edition 2020-
                             shape distributions by transmission electron         06.
                             microscopy.
18-18.....................  Standard Test Method for Measuring the Size of       ASTM E3247-20.
                             Nanoparticles in Aqueous Media Using Dynamic Light
                             Scattering.
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
----------------------------------------------------------------------------------------------------------------
17-17.....................  Standard Specification for Neurosurgical Head        ASTM F3395/F3395M-19.
                             Holder Devices.
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-121....................  Ophthalmic implants--Ocular endotamponades.........  ISO 16672 Third edition 2020-
                                                                                  06.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-230....................  American National Standard for Wheelchairs--Volume   ANSI/RESNA WC-2:2019 Section
                             2: Additional Requirements for Wheelchairs           25.
                             (including Scooters) with Electrical Systems
                             Section 25: Batteries and Chargers for Powered
                             Wheelchairs.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-116....................  Common Vulnerability Scoring System version 3.0....  FIRST CVSS v3.0.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                              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

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

[[Page 22686]]

recommendation, to [email protected]. To be considered, 
such recommendations should contain, at a minimum, the information 
available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08992 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P