Document ID: FDA-2004-N-0451-0050
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056
Posted Date: 2021-12-09T05:00Z

[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70132-70139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26635]

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

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: 056

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: 056'' (Recognition List Number: 056), 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 December 9, 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:

[[Page 70133]]

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 056.'' 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: 056.
     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: 056 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: 
056 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: 056'' 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: 056

    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

[[Page 70134]]

Number: 056'' 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: 056.

----------------------------------------------------------------------------------------------------------------
                                  Replacement
      Old recognition No.         recognition             Title of standard \1\                   Change
                                      No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-115.........................           1-151  ISO 80601-2-70 Second edition 2020-11     Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 70: Particular requirements for the
                                                 basic safety and essential performance
                                                 of sleep apnea breathing therapy
                                                 equipment.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-191.........................           2-289  ISO 10993-12 Fifth edition 2021-01        Withdrawn and replaced
                                                 Biological evaluation of medical          with newer version.
                                                 devices--Part 12: Sample preparation
                                                 and reference materials.
2-241.........................  ..............  ISO/TR 37137 First edition 2014-05-15     Withdrawn. See 2-290.
                                                 Cardiovascular biological evaluation of
                                                 medical devices--Guidance for
                                                 absorbable implants.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-92..........................           3-170  ISO 14708-5 Second edition 2020-05        Withdrawn and replaced
                                                 Implants for surgery--Active              with newer version.
                                                 implantable medical devices--Part 5:
                                                 Circulatory support devices.
3-129.........................  ..............  ANSI/AAMI EC53:2013/(R)2020 ECG trunk     Extent of recognition.
                                                 cables and patient leadwires.
3-166.........................  ..............  ISO 81060-2 Third edition 2018-11         Extent of recognition.
                                                 Noninvasive sphygmomanometers--Part 2:
                                                 Clinical investigation of intermittent
                                                 automated measurement type [Including:
                                                 Amendment 1 (2020)].
3-168.........................  ..............  IEEE Std 1708-2014 Standard for           Extent of recognition.
                                                 Wearable, Cuffless Blood Pressure
                                                 Measuring Devices [Including: Amendment
                                                 1 (2019)].
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105.........................  ..............  ANSI/ADA Standard No. 75--1997 (R2014)    Withdrawn.
                                                 Resilient Lining Materials for
                                                 Removable Dentures, Part 1: Short-Term
                                                 Materials.
4-164.........................           4-273  ANSI/ASA S3.7-2016 (Reaffirmed 2020)      Withdrawn and replaced
                                                 American National Standard Method for     with newer version.
                                                 Measurement and Calibration of
                                                 Earphones.
4-183.........................           4-274  ANSI/ASA S3.2-2020 American National      Withdrawn and replaced
                                                 Standard Method for Measuring the         with newer version.
                                                 Intelligibility of Speech over
                                                 Communication Systems.
4-194.........................  ..............  ANSI/ADA Standard No. 78--2006 Dental     Withdrawn.
                                                 obturating cones (Modified adoption of
                                                 ISO 6877-1:1995, Dental obturating
                                                 points).
4-195.........................  ..............  ISO 14801 Second edition 2007-11-15       Withdrawn.
                                                 Dentistry--Implants--Dynamic fatigue
                                                 test for endosseous dental implants.
4-203.........................           4-275  ANSI/ASA S3.6-2018 American National      Withdrawn and replaced
                                                 Standard Specification for Audiometers.   with newer version.
4-206.........................           4-276  ISO 14457 Second edition 2017-10          Withdrawn and replaced
                                                 Dentistry--Handpieces and motors.         with newer version.
4-216.........................           4-277  ANSI/IEEE C63.19-2019 American National   Withdrawn and replaced
                                                 Standard Methods of Measurement of        with newer version.
                                                 Compatibility between Wireless
                                                 Communication Devices and Hearing Aids.
4-225.........................           4-278  ISO 4823 Fifth edition 2021-02            Withdrawn and replaced
                                                 Dentistry--Elastomeric impression and     with newer version.
                                                 bite registration materials.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-23.........................           19-40  IEC 60086-4 Edition 5.0 2019-04 Primary   Withdrawn and replaced
                                                 batteries--Part 4: Safety of lithium      with newer version.
                                                 batteries [Including: Corrigendum 1
                                                 (2019) and Corrigendum 2 (2020)].

[[Page 70135]]

 
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-385.........................           6-461  IEC 60601-2-19 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 19: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant incubators.
6-386.........................           6-462  IEC 60601-2-20 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 20: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant transport incubators.
6-388.........................           6-463  IEC 60601-2-21 Edition 3.0 2020-09        Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-     with newer version.
                                                 21: Particular requirements for the
                                                 basic safety and essential performance
                                                 of infant radiant warmers.
6-389.........................  ..............  IEC 60601-2-2 Edition 6.0 2017-03         Extent of recognition.
                                                 Medical electrical equipment--Part 2-2:
                                                 Particular requirements for the basic
                                                 safety and essential performance of
                                                 high frequency surgical equipment and
                                                 high frequency surgical accessories.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-193.........................           7-306  CLSI EP06 2nd Edition Evaluation of the   Withdrawn and replaced
                                                 Linearity of Quantitative Measurement     with newer version.
                                                 Procedures.
7-209.........................           7-307  CLSI POCT05 2nd Edition Performance       Withdrawn and replaced
                                                 Metrics for Continuous Interstitial       with newer version.
                                                 Glucose Monitoring.
7-236.........................  ..............  CLSI M43-A October 2011 Methods for       Extent of recognition.
                                                 Antimicrobial Susceptibility Testing
                                                 for Human Mycoplasmas; Approved
                                                 Guideline.
7-262.........................  ..............  CLSI M45 3rd Edition Methods for          Extent of recognition.
                                                 Antimicrobial Dilution and Disk
                                                 Susceptibility Testing of Infrequently
                                                 Isolated or Fastidious Bacteria.
7-292.........................  ..............  CLSI M62 1st Edition Performance          Extent of recognition.
                                                 Standards for Susceptibility Testing of
                                                 Mycobacteria, Nocardia spp., and Other
                                                 Aerobic Actinomycetes.
7-294.........................           7-308  CLSI M100 31st Edition Performance        Withdrawn and replaced
                                                 Standards for Antimicrobial               with newer version.
                                                 Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-394.........................           8-555  ASTM F1472-20a Standard Specification     Withdrawn and replaced
                                                 for Wrought Titanium-6Aluminum-           with newer version.
                                                 4Vanadium Alloy for Surgical Implant
                                                 Applications (UNS R56400).
8-418.........................           8-556  ASTM F640-20 Standard Test Methods for    Withdrawn and replaced
                                                 Determining Radiopacity for Medical       with newer version.
                                                 Use.
8-445.........................  ..............  ISO 17296-4 First edition 2014-09-01      Withdrawn. See 8-561.
                                                 Additive manufacturing--General
                                                 principles--Part 4: Overview of data
                                                 processing.
8-486.........................           8-557  ASTM F3268--18a Standard Guide for in     Withdrawn and replaced
                                                 vitro Degradation Testing of Absorbable   with newer version.
                                                 Metals.
8-490.........................  ..............  ASTM F3303-18 Standard for additive       Withdrawn. See 8-562.
                                                 manufacturing--Process characteristics
                                                 and performance--Practice for metal
                                                 powder bed fusion process to meet
                                                 critical applications.
----------------------------------------------------------------------------------------------------------------
                                                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)
----------------------------------------------------------------------------------------------------------------
9-39..........................           9-131  ISO 8600-5 Second Edition 2020-10 Optics  Withdrawn and replaced
                                                 and photonics--Medical endoscopes and     with newer version.
                                                 endotherapy devices--Part 5:
                                                 Determination of optical resolution of
                                                 rigid endoscopes with optics.
9-44..........................           9-132  ASTM F623-19 Standard Performance         Withdrawn and replaced
                                                 Specification for Foley Catheter.         with newer version.
9-53..........................  ..............  ASTM F1992-99 (Reapproved 2007) Standard  Withdrawn.
                                                 Practice for Reprocessing of Reusable,
                                                 Heat-Stable Endoscopic Accessory
                                                 Instruments (EAI) Used with Flexible
                                                 Endoscopes.
9-95..........................  ..............  CENEN 1615:2000 Enteral Feeding           Withdrawn. See 9-138.
                                                 Catheters and Enteral Giving Sets for
                                                 Single Use and their Connectors-Design
                                                 and Testing.
9-97..........................  ..............  ISO 13958 Third edition 2014-04-01        Withdrawn. See 9-136.
                                                 Concentrates for haemodialysis and
                                                 related therapies.

[[Page 70136]]

 
9-98..........................  ..............  ISO 13959 Third edition 2014-04-01 Water  Withdrawn. See 9-135.
                                                 for haemodialysis and related
                                                 therapies.
9-99..........................  ..............  ISO 23500 Second edition 2014-04-01       Withdrawn. See 9-133.
                                                 Guidance for the preparation and
                                                 quality management of fluids for
                                                 haemodialysis and related therapies.
9-100.........................  ..............  ISO 11663 Second edition 2014-04-01       Withdrawn. See 9-137.
                                                 Quality of dialysis fluid for
                                                 haemodialysis and related therapies.
9-101.........................  ..............  ISO 26722 Second edition 2014-04-01       Withdrawn. See 9-134.
                                                 Water treatment equipment for
                                                 haemodialysis applications and related
                                                 therapies.
9-113.........................  ..............  CENEN 1618:1997 Catheters other than      Withdrawn. See 9-138.
                                                 intravascular catheters--Test methods
                                                 for common properties.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-35.........................          10-122  ISO 10939 Third edition 2017-05           Withdrawn and replaced
                                                 Ophthalmic instruments--Slit-lamp         with newer version.
                                                 microscopes.
10-72.........................          10-123  ISO 15004-1 Second edition 2020-5         Withdrawn and replaced
                                                 Ophthalmic instruments--Fundamental       with newer version.
                                                 requirements and test methods--Part 1:
                                                 General requirements applicable to all
                                                 ophthalmic instruments.
10-79.........................          10-124  ISO 11979-1 Fourth edition 2018-11        Withdrawn and replaced
                                                 Ophthalmic implants--Intraocular          with newer version.
                                                 lenses--Part 1: Vocabulary.
10-81.........................          10-125  ISO 11979-7 Fourth edition 2018-03        Withdrawn and replaced
                                                 Ophthalmic implants--Intraocular          with newer version.
                                                 lenses--Part 7: Clinical investigations
                                                 of intraocular lenses for the
                                                 correction of aphakia.
10-90.........................  ..............  ISO 11979-9 First edition 2006-09-01      Withdrawn.
                                                 Ophthalmic implants--Intraocular
                                                 lenses--Part 9: Multifocal intraocular
                                                 lenses [Including: Amendment 1 (2014)].
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-238........................          11-376  ASTM F2033-20 Standard Specification for  Withdrawn and replaced
                                                 Total Hip Joint Prosthesis and Hip        with newer version.
                                                 Endoprosthesis Bearing Surfaces Made of
                                                 Metallic, Ceramic, and Polymeric
                                                 Materials.
11-258........................          11-377  ASTM F2083-21 Standard Specification for  Withdrawn and replaced
                                                 Knee Replacement Prosthesis.              with newer version.
11-270........................          11-378  ASTM F2502-17 Standard Specification and  Withdrawn and replaced
                                                 Test Methods for Absorbable Plates and    with newer version.
                                                 Screws for Internal Fixation Implants.
11-285........................          11-379  ASTM F2978-20 Standards Guide to          Withdrawn and replaced
                                                 Optimize Scan Sequences for Clinical      with newer version.
                                                 Diagnostic Evaluation of Metal-on-Metal
                                                 Hip Arthroplasty Devices using Magnetic
                                                 Resonance Imaging.
11-286........................          11-380  ASTM F2979-20 Standard Guide for          Withdrawn and replaced
                                                 Characterization of Wear from the         with newer version.
                                                 Articulating Surfaces in Retrieved
                                                 Metal-on-Metal and other Hard-on-Hard
                                                 Hip Prostheses.
11-293........................          11-381  ASTM F2582-20 Standard Test Method for    Withdrawn and replaced
                                                 Dynamic Impingement Between Femoral and   with newer version.
                                                 Acetabular Hip Components.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-260........................          12-335  IEC 60336 Edition 5.0 2020-12 Medical     Withdrawn and replaced
                                                 electrical equipment--X-ray tube          with newer version.
                                                 assemblies for medical diagnosis--Focal
                                                 spot dimensions and related
                                                 characteristics.
12-269........................          12-336  IEC 60601-1-3 Edition 2.2 2021-01         Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 1-3: General
                                                 requirements for basic safety and
                                                 essential performance--Collateral
                                                 Standard: Radiation protection in
                                                 diagnostic X-ray equipment.
12-284........................          12-337  NEMA NU 1-2018 Performance Measurements   Withdrawn and replaced
                                                 of Gamma Cameras.                         with newer version.
12-285........................          12-338  IEC 60601-2-1 Edition 4.0 2020-10         Withdrawn and replaced
                                                 Medical electrical equipment--Part 2-1:   with newer version.
                                                 Particular requirements for the basic
                                                 safety and essential performance of
                                                 electron accelerators in the range 1
                                                 MeV to 50 MeV.
12-310........................          12-339  IEC 60601-2-63 Edition 1.2 2021-05        Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 2-63: Particular
                                                 requirements for the basic safety and
                                                 essential performance of dental extra-
                                                 oral X-ray equipment.

[[Page 70137]]

 
12-311........................          12-340  IEC 60601-2-65 Edition 1.2 2021-05        Withdrawn and replaced
                                                 CONSOLIDATED VERSION Medical electrical   with newer version.
                                                 equipment--Part 2-65: Particular
                                                 requirements for the basic safety and
                                                 essential performance of dental intra-
                                                 oral X-ray equipment.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-511........................          14-562  ANSI/AAMI ST79:2017 & 2020 Amendments     Withdrawn and replaced
                                                 A1, A2, A3, A4 (Consolidated Text)        with newer version.
                                                 Comprehensive guide to steam
                                                 sterilization and sterility assurance
                                                 in health care facilities.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-10.........................  ..............  ASTM F2451-05 (Reapproved 2010) Standard  Withdrawn.
                                                 Guide for in vivo Assessment of
                                                 Implantable Devices Intended to Repair
                                                 or Regenerate Articular Cartilage.
15-32.........................           15-66  ASTM F2260-18 Standard Test Method for    Withdrawn and replaced
                                                 Determining Degree of Deacetylation in    with newer version.
                                                 Chitosan Salts by Proton Nuclear
                                                 Magnetic Resonance (1HNMR)
                                                 Spectroscopy.
15-60.........................           15-67  ASTM F2212-20 Standard Guide for          Withdrawn and replaced
                                                 Characterization of Type I Collagen as    with newer version.
                                                 Starting Materials for Surgical
                                                 Implants and Substrates for Tissue
                                                 Engineered Medical Products (TEMPs).
----------------------------------------------------------------------------------------------------------------
\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: 056. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-290............................  Biological evaluation of absorbable medical devices-- ISO/TS 37137-1 First edition 2021-03.
                                    Part 1: General requirements.
2-291............................  Biological evaluation of medical devices--Part 23:    ISO 10993-23 First edition 2021-01.
                                    Tests for irritation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    C. Cardiovascular
                                                               No new entries at this time
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          D. Dental/Ear, Nose, and Throat (ENT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-279............................  Part 1: Disposable Prophy Angles....................  ANSI/ADA Standard No. 85-2004 (R2009).
4-280............................  Fluoride Varnishes..................................  ANSI/ADA Standard No. 117-2018.
4-281............................  Dentistry--Shanks for rotary and oscillating          ISO 1797 Third edition 2017-05.
                                    instruments.
4-282............................  Dentistry--Denture adhesives........................  ISO 10873 First edition 2010-09.
4-283............................  Dentistry--Oral care products--Manual interdental     ISO 16409 Second edition 2016-10.
                                    brushes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                 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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-460............................  Standard Specification for Barrier Face Coverings...  ASTM F3502-21.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 70138]]

 
                                                              H. In Vitro Diagnostics (IVD)
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      I. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-558............................  Standard Specification for Chopped Carbon Fiber       ASTM F3333-20.
                                    Reinforced (CFR) Polyetheretherketone (PEEK)
                                    Polymers for Surgical Implant Applications.
8-559............................  Standard Test Methods for Vulcanized Rubber and       ASTM D412-16e1.
                                    Thermoplastic Elastomers--Tension.
8-560............................  Standard Test Method for Rubber Property--            ASTM D1415-18.
                                    International Hardness.
8-561............................  Additive manufacturing--General principles--Overview  ISO/ASTM 52950 First edition 2021-01.
                                    of data processing.
8-562............................  Additive manufacturing--Process characteristics and   ISO/ASTM 52904 First edition 2019-08.
                                    performance--Practice for metal powder bed fusion
                                    process to meet critical applications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-133............................  Preparation and quality management of fluids for      ISO 23500-1 First edition 2019-02.
                                    haemodialysis and related therapies--Part 1:
                                    General requirements.
9-134............................  Preparation and quality management of fluids for      ISO 23500-2 First edition 2019-02.
                                    haemodialysis and related therapies--Part 2: Water
                                    treatment equipment for haemodialysis applications
                                    and related therapies.
9-135............................  Preparation and quality management of fluids for      ISO 23500-3 First edition 2019-02.
                                    haemodialysis and related therapies--Part 3: Water
                                    for haemodialysis and related therapies.
9-136............................  Preparation and quality management of fluids for      ISO 23500-4 First edition 2019-02.
                                    haemodialysis and related therapies--Part 4:
                                    Concentrates for haemodialysis and related
                                    therapies.
9-137............................  Preparation and quality management of fluids for      ISO 23500-5 First edition 2019-02.
                                    haemodialysis and related therapies--Part 5:
                                    Quality of dialysis fluid for haemodialysis and
                                    related therapies.
9-138............................  Enteral feeding systems--Design and testing.........  ISO 20695 First edition 2020-03.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      M. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-126...........................  Medical electrical equipment--Part 2-58: Particular   IEC 80601-2-58 Edition 2.0 2014-09.
                                    requirements for basic safety and essential
                                    performance of lens removal devices and vitrectomy
                                    devices for ophthalmic surgery [Including AMENDMENT
                                    1 (2016)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      N. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-382...........................  Standard Test Method for Fatigue Testing of           ASTM F3090-20.
                                    Acetabular Devices for Total Hip Replacement.
11-383...........................  Standard Test Method for Determination of Frictional  ASTM F3143-20.
                                    Torque and Friction Factor for Hip Replacement
                                    Bearings under Standard Conditions Using a
                                    Reciprocal Friction Simulator.
11-384...........................  Standard Test Method for Determination of Frictional  ASTM F3446-20.
                                    Torque and Friction Factor for Hip Implants Using
                                    an Anatomical Motion Hip Simulator.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  O. Physical Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
16-231...........................  Prosthetics--Structural testing of lower-limb         ISO 10328 Second edition 2016-06-01.
                                    prostheses--Requirements and test methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      P. Radiology
                                                              No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Q. Software/Informatics
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-117...........................  Health informatics--Device interoperability Part      IEEE Std 11073-40101-2020.
                                    40101: Foundational--Cybersecurity--Processes for
                                    vulnerability assessment.
13-118...........................  Health informatics--Device interoperability Part      IEEE Std 11073-40102-2020.
                                    40102: Foundational--Cybersecurity--Capabilities
                                    for mitigation.
13-119...........................  Security for industrial automation and control        ANSI/ISA-62443-4-1-2018.
                                    systems Part 4-1: Product security development life-
                                    cycle requirements..
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 70139]]

 
                                                                      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

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

V. Recommendation of Standards for Recognition by FDA

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

    Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26635 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P