Document ID: FDA-2004-N-0451-0048
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 054
Posted Date: 2021-03-03T05:00Z

[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12476-12482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04376]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 054

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: 054'' (Recognition List Number: 054), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit either electronic or written comments on the notice at 
any time. These modifications to the list of recognized standards are 
applicable March 3, 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 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: 054.'' 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: 054.
     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: 054 is available on 
the internet at https://www.fda.gov/MedicalDevices/

[[Page 12477]]

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: 
054 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: 054'' 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, 
CDRHStandardsStaff@fda.hhs.gov.

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: 054

    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: 054'' 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: 054.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                       Replacement
        Old recognition No.            recognition        Title of standard \1\                 Change
                                           No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-98...............................           1-146  ISO 80601-2-12 Second edition    Withdrawn and replaced
                                                      2020-02 Medical electrical       with newer version.
                                                      equipment--Part 2-12:
                                                      Particular requirements for
                                                      basic safety and essential
                                                      performance of critical care
                                                      ventilators.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-168..............................           2-273  ISO 10993-9 Third edition 2019-  Withdrawn and replaced
                                                      11 Biological evaluation of      with newer version.
                                                      medical devices--Part 9:         Extent of recognition.
                                                      Framework for identification
                                                      and quantification of
                                                      potential degradation products.
2-197..............................           2-274  ASTM F749--20 Standard Practice  Withdrawn and replaced
                                                      for Evaluating Material          with newer version.
                                                      Extracts by Intracutaneous
                                                      Injection in the Rabbit.
2-238..............................  ..............  ANSI/AAMI BE83:2006/(R)2011      Withdrawn.
                                                      Biological evaluation of
                                                      medical devices--Part 18:
                                                      Chemical characterization of
                                                      materials.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-55...............................           3-164  ASTM F1830--19 Standard          Withdrawn and replaced
                                                      Practice for Collection and      with newer version.
                                                      Preparation of Blood for
                                                      Dynamic In Vitro Evaluation of
                                                      Blood Pumps.
3-56...............................           3-165  ASTM 1841--19 Standard Practice  Withdrawn and replaced
                                                      for Assessment of Hemolysis in   with newer version.
                                                      Continuous Flow Blood Pumps.
3-127..............................           3-155  ANSI/AAMI/IEC 60601-2-47:2012/   Transferred.
                                                      (R)2016 Medical electrical
                                                      equipment--Part 2-47:
                                                      Particular requirements for
                                                      the basic safety and essential
                                                      performance of ambulatory
                                                      electrocardiographic systems.
3-142..............................           8-525  ISO/TS 17137 Second edition      Withdrawn and replaced
                                                      2019-09 Cardiovascular           with newer version.
                                                      implants and extracorporeal      Transferred.
                                                      systems--Cardiovascular
                                                      absorbable implants.

[[Page 12478]]

 
3-152..............................           3-123  IEC 80601-2-30: Edition 2.0      Withdrawn and replaced
                                                      2018-03 Medical electrical       with newer version.
                                                      equipment Part 2-30:
                                                      Particular requirements for
                                                      basic safety and essential
                                                      performance of automated type
                                                      non-invasive sphygmomanometers.
3-160..............................           3-166  ISO 81060-2 Third edition 2018-  Withdrawn and replaced
                                                      11 Non-invasive                  with newer version.
                                                      sphygmomanometers--Part 2:
                                                      Clinical investigation of
                                                      intermittent automated
                                                      measurement type [Including
                                                      AMENDMENT1 (2020)].
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-201..............................           4-263  ISO 9693 Third edition 2019-10   Withdrawn and replaced
                                                      Dentistry--Compatibility         with newer version.
                                                      testing for metal-ceramic and
                                                      ceramic-ceramic systems.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-110..............................           5-126  ISTA 3A 2018 Packaged-Products   Withdrawn and replaced
                                                      for Parcel Delivery System       with newer version.
                                                      Shipment 70 kg (150 lb) or
                                                      Less.
5-111..............................           5-127  ISTA 3B 2017 Packaged-Products   Withdrawn and replaced
                                                      for Less-Than-Truckload (LTL)    with newer version.
                                                      Shipment.
5-112..............................           5-128  ISTA 3E 2017 Similar Packaged-   Withdrawn and replaced
                                                      Products in Unitized Loads of    with newer version.
                                                      Truckload Shipment.
5-114..............................           5-129  IEC 62366-1 Edition 1.1 2020-06  Withdrawn and replaced
                                                      CONSOLIDATED VERSION Medical     with newer version.
                                                      devices--Part 1: Application
                                                      of usability engineering to
                                                      medical devices.
5-116..............................           5-130  ISO 7010 Third edition 2019-07   Withdrawn and replaced
                                                      Graphical symbols--Safety        with newer version.
                                                      colours and safety signs--
                                                      Registered safety signs.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-68...............................           6-439  ISO 7886-2 Second edition 2020-  Withdrawn and replaced
                                                      04 Sterile hypodermic syringes   with newer version.
                                                      for single use--Part 2:
                                                      Syringes for use with power-
                                                      driven syringe pumps.
6-145..............................           6-440  ASTM D3578--19 Standard          Withdrawn and replaced
                                                      Specification for Rubber         with newer version.
                                                      Examination Gloves.
6-148..............................           6-441  ISO 7886-3 Second edition 2020-  Withdrawn and replaced
                                                      05 Sterile hypodermic syringes   with newer version.
                                                      for single use--Part 3: Auto-
                                                      disabled syringes for fixed-
                                                      dose immunization.
6-165..............................           6-442  ASTM D6977--19 Standard          Withdrawn and replaced
                                                      Specification for                with newer version.
                                                      Polychloroprene Examination
                                                      Gloves for Medical Application.
6-168..............................           6-443  ASTM D3577--19 Standard          Withdrawn and replaced
                                                      Specification for Rubber         with newer version.
                                                      Surgical Gloves.
6-176..............................           6-444  ASTM D7103--19 Standard Guide    Withdrawn and replaced
                                                      for Assessment of Medical        with newer version.
                                                      Gloves.
6-178..............................  ..............  ASTM D6124--06 (Reapproved       Extent of recognition.
                                                      2017) Standard Test Method for
                                                      Residual Powder on Medical
                                                      Gloves.
6-183..............................           6-445  ASTM D5250--19 Standard          Withdrawn and replaced
                                                      Specification for Poly(vinyl     with newer version.
                                                      chloride) Gloves for Medical
                                                      Application.
6-244..............................           6-446  ASTM D6319--19 Standard          Withdrawn and replaced
                                                      Specification for Nitrile        with newer version.
                                                      Examination Gloves for Medical
                                                      Application.
6-318..............................           6-447  ISO 8536-4 Sixth edition 2019-   Withdrawn and replaced
                                                      09 Infusion equipment for        with newer version.
                                                      medical use--Part 4: Infusion
                                                      sets for single use, gravity
                                                      feed.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-227..............................           8-526  ASTM F2182--19[epsi]2 Standard   Withdrawn and replaced
                                                      Test Method for Measurement of   with newer version.
                                                      Radio Frequency Induced
                                                      Heating On or Near Passive
                                                      Implants During Magnetic
                                                      Resonance Imaging.
8-343..............................           8-527  ASTM F899--20 Standard           Withdrawn and replaced
                                                      Specification for Wrought        with newer version.
                                                      Stainless Steels for Surgical
                                                      Instruments.
8-349..............................           8-528  ASTM F2503--20 Standard          Withdrawn and replaced
                                                      Practice for Marking Medical     with newer version.
                                                      Devices and Other Items for
                                                      Safety in the Magnetic
                                                      Resonance Environment.

[[Page 12479]]

 
8-374..............................           8-529  ASTM F2633--19 Standard          Withdrawn and replaced
                                                      Specification for Wrought        with newer version.
                                                      Seamless Nickel-Titanium Shape
                                                      Memory Alloy Tube for Medical
                                                      Devices and Surgical Implants.
8-461..............................           8-530  ASTM F3208--19 Standard Guide    Withdrawn and replaced
                                                      for Selecting Test Soils for     with newer version.
                                                      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)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-215.............................          11-363  ASTM F897--19 Standard Test      Withdrawn and replaced
                                                      Method for Measuring Fretting    with newer version.
                                                      Corrosion of Osteosynthesis
                                                      Plates and Screws.
11-222.............................          11-364  ISO 14243-1 Second edition 2009- Withdrawn and replaced
                                                      11-15 Implants for surgery--     with newer version.
                                                      Wear of total knee-joint
                                                      prostheses--Part 1: Loading
                                                      and displacement parameters
                                                      for wear-testing machines with
                                                      load control and corresponding
                                                      environmental conditions for
                                                      test [Including AMENDMENT1
                                                      (2020)].
11-253.............................          11-365  ASTM F1800--19[epsi]1 Standard   Withdrawn and replaced
                                                      Practice for Cyclic Fatigue      with newer version.
                                                      Testing of Metal Tibial Tray
                                                      Components of Total Knee Joint
                                                      Replacements.
11-275.............................          11-366  ASTM F2381--19 Standard Test     Withdrawn and replaced
                                                      Method for Evaluating Trans-     with newer version.
                                                      Vinylene Yield in Irradiated
                                                      Ultra-High Molecular Weight
                                                      Polyethylene Fabricated Forms
                                                      Intended for Surgical Implants
                                                      by Infrared Spectroscopy.
11-292.............................          11-367  ISO 14243-3 Second edition 2014- Withdrawn and replaced
                                                      11-01 Implants for surgery--     with newer version.
                                                      Wear of total knee-joint
                                                      prostheses--Part 3: Loading
                                                      and displacement parameters
                                                      for wear-testing machines with
                                                      displacement control and
                                                      corresponding environmental
                                                      conditions for test [Including
                                                      AMENDMENT 1 (2020)].
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-170.............................  ..............  ANSI RESNA WC-1:2009 Section 3   Title change.
                                                      American National Standard for
                                                      Wheelchairs--Volume 1:
                                                      Additional Requirements for
                                                      Wheelchairs (including
                                                      Scooters) Section 3:
                                                      Determination of effectiveness
                                                      of brakes.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-287.............................          12-330  NEMA Standards Publication XR    Withdrawn and replaced
                                                      28-2018 Supplemental             with newer version.
                                                      Requirements for User
                                                      Information and System
                                                      Function Related to Dose in CT.
12-325.............................  ..............  NEMA Standards Publication XR    Transition period
                                                      25-2019 Computed Tomography      extended.
                                                      Dose Check.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-80..............................          13-113  IEEE Std 11073-20601-2019        Withdrawn and replaced
                                                      Health informatics--Personal     with newer version.
                                                      health device communication--
                                                      Part 20601: Application
                                                      profile--Optimized exchange
                                                      protocol.
13-110.............................          13-114  IEEE Std 11073-10101-2019        Withdrawn and replaced
                                                      Health informatics--Point-of-    with newer version.
                                                      care medical device
                                                      communication--Part 10101:
                                                      Nomenclature.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-313.............................          14-539  ASTM F2475--20 Standard Guide    Withdrawn and replaced
                                                      for Biocompatibility             with newer version.
                                                      Evaluation of Medical Device
                                                      Packaging Materials.

[[Page 12480]]

 
14-327.............................          14-540  ISO 11737-2 Third edition 2019-  Withdrawn and replaced
                                                      12 Sterilization of health       with newer version.
                                                      care products--Microbiological
                                                      methods--Part 2: Tests of
                                                      sterility performed in the
                                                      definition, validation and
                                                      maintenance of a sterilization
                                                      process.
14-360.............................          14-541  ANSI/AAMI ST72:2019 Bacterial    Withdrawn and replaced
                                                      endotoxins--Test methods,        with newer version.
                                                      routine monitoring, and
                                                      alternatives to batch testing.
14-408.............................           2-275  ISO 10993-7 Second edition 2008- Withdrawn and replaced
                                                      10-15 Biological evaluation of   with newer version.
                                                      medical devices--Part 7:         Transferred.
                                                      Ethylene oxide sterilization
                                                      residuals [Including
                                                      Corrigendum 1 (2009) and
                                                      AMENDMENT 1 (2020)].
14-436.............................          14-542  ISO/ASTM 52628 Second edition    Withdrawn and replaced
                                                      2020-04 Standard practice for    with newer version.
                                                      dosimetry in radiation
                                                      processing.
14-515.............................  ..............  ISO 17664 Second edition 2017-   Extent of recognition.
                                                      10 Processing of health care
                                                      products--Information to be
                                                      provided by the medical device
                                                      manufacturer for the
                                                      processing of medical devices.
14-528.............................          14-543  ISO 11139 First edition 2018-08  New recognition number.
                                                      Sterilization of health care
                                                      products--Vocabulary of terms
                                                      used in sterilization and
                                                      related equipment and process
                                                      standards.
14-529.............................          14-544  ISO 18472 Second edition 2018-   New recognition number.
                                                      08 Sterilization of health
                                                      care products--Biological and
                                                      chemical indicators--Test
                                                      equipment.
14-530.............................          14-545  ISO/ASTM 51276 Fourth edition    New recognition number.
                                                      2019-08 Practice for use of a
                                                      polymethylmethacrylate
                                                      dosimetry system.
14-531.............................          14-546  USP 42-NF37:2019 <61>            New recognition number.
                                                      Microbiological Examination of
                                                      Nonsterile Products: Microbial
                                                      Enumeration Tests.
14-532.............................          14-547  USP 42-NF37:2019 <71> Sterility  New recognition number.
                                                      Tests.
14-533.............................          14-548  USP 42-NF37:2019 <85> Bacterial  New recognition number.
                                                      Endotoxins Test.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-19..............................           15-59  ASTM F2450--18 Standard Guide    Withdrawn and replaced
                                                      for Assessing Microstructure     with newer version.
                                                      of Polymeric Scaffolds for Use
                                                      in Tissue-Engineered Medical
                                                      Products.
15-30..............................           15-60  ASTM F2212--19 Standard Guide    Withdrawn and replaced
                                                      for Characterization of Type I   with newer version.
                                                      Collagen as Starting Material
                                                      for Surgical Implants and
                                                      Substrates for Tissue
                                                      Engineered Medical Products
                                                      (TEMPs).
15-39..............................           15-61  ASTM F2150 19 Standard Guide     Withdrawn and replaced
                                                      for Characterization and         with newer version.
                                                      Testing of Biomaterial
                                                      Scaffolds Used in Regenerative
                                                      Medicine and Tissue-Engineered
                                                      Medical Products.
15-41..............................           15-62  ASTM F2602--18 Standard Test     Withdrawn and replaced
                                                      Method for Determining the       with newer version.
                                                      Molar Mass of Chitosan and
                                                      Chitosan Salts by Size
                                                      Exclusion Chromatography with
                                                      Multi-angle Light Scattering
                                                      Detection (SEC-MALS).
15-50..............................           15-63  ASTM F2739--19 Standard Guide    Withdrawn and replaced
                                                      for Quantifying Cell Viability   with newer version.
                                                      and Related Attributes within
                                                      Biomaterial Scaffolds.
----------------------------------------------------------------------------------------------------------------
\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: 054. 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
----------------------------------------------------------------------------------------------------------------
2-276.........................  Biological evaluation of medical devices--Part     ISO 10993-18 Second edition
                                 18: Chemical characterization of medical device    2020-01.
                                 materials within a risk management process.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-167.........................  Non-invasive sphygmomanometers--Part 5:            ISO/TS 81060-5 First edition
                                 Requirements for the repeatability and             2020-02.
                                 reproducibility of NIBP simulators for testing
                                 of automated non-invasive sphygmomanometers.

[[Page 12481]]

 
3-168.........................  Standard for Wearable, Cuffless Blood Pressure     IEEE Std 1708-2014.
                                 Measuring Devices [Including Amendment 1 (2019)].
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                             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)
----------------------------------------------------------------------------------------------------------------
7-296.........................  Measurement Procedure Comparison and Bias          CLSI EP09c 3rd Edition.
                                 Estimation Using Patient Samples.
7-297.........................  Medical laboratories--Practical guidance for the   ISO/TS 20914 First edition
                                 estimation of measurement uncertainty.             2019-07.
7-298.........................  Assessment of Equivalence or Suitability of        CLSI EP35 1st Edition.
                                 Specimen Types for Medical Laboratory
                                 Measurement Procedures.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-531.........................  Standard Guide for Methods of Extraction of Test   ASTM F3321--19.
                                 Soils for the Validation of Cleaning Methods for
                                 Reusable Medical Devices.
8-532.........................  Standard Guide for Assessing the Removal of        ASTM F3335--20.
                                 Additive Manufacturing Residues in Medical
                                 Devices Fabricated by Powder Bed Fusion.
8-533.........................  Additive Manufacturing--Feedstock materials--      ISO/ASTM 52907: First Edition
                                 Methods to characterize metal powders.             2019-11.
8-534.........................  Additive Manufacturing--Design--Part 1: Laser-     ISO/ASTM 52911-1: First
                                 based powder bed fusion of metals.                 Edition 2019-07.
8-535.........................  Additive Manufacturing--Design--Part 2: Laser-     ISO/ASTM 52911-2: First
                                 based powder bed fusion of polymers.               Edition 2019-09.
8-536.........................  Additive Manufacturing--Test Artifacts--Geometric  ISO/ASTM 52902: First Edition
                                 capability assessment of additive manufacturing    2019-07.
                                 systems.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-15.........................  Standard Guide for Tiered Approach to Detection    ASTM E3025--16.
                                 and Characterization of Silver Nanomaterials in
                                 Textiles..
18-16.........................  Nanotechnologies--Analysis of nano-objects using   ISO/TS 21362 First edition
                                 asymmetrical-flow and centrifugal field-flow       2018-06.
                                 fractionation.
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-124.........................  Colorimetry--Part 1: CIE standard colorimetric     ISO/CIE 11664-1 First edition
                                 observers.                                         2019-06.
9-125.........................  Colorimetry--Part 2: CIE standard illuminants....  ISO 11664-2 CIE S 014-2/E
                                                                                    First edition 2007-10-15
                                                                                    Corrected version 2008-11-
                                                                                    01.
9-126.........................  Colorimetry--Part 3: CIE tristimulus values......  ISO/CIE 11664-3 First edition
                                                                                    2019-06.
9-127.........................  Colorimetry--Part 4: CIE 1976 L*a*b* colour space  ISO/CIE 11664-4 First edition
                                                                                    2019-06.
9-128.........................  Colorimetry--Part 6: CIEDE2000 colour-difference   ISO/CIE 11664-6 First edition
                                 formula.                                           2014-02-01.
9-129.........................  Multimedia systems and equipment--Colour           IEC 61966-2-1 First edition
                                 measurement and management--Part 2-1: Colour       1999-10.
                                 management--Default RGB colour space--sRGB
                                 [Including Amendment 1 (2003) and Corrigendum 1
                                 (2014)].
----------------------------------------------------------------------------------------------------------------

[[Page 12482]]

 
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-368........................  Standard Practice for Finite Element Analysis      ASTM F3334--19.
                                 (FEA) of Metallic Orthopaedic Total Knee Tibial
                                 Components.
11-369........................  Standard Practice for Inspection of Spinal         ASTM F3292--19.
                                 Implants Undergoing Testing.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
                                          No new entries at this time.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-331........................  Characterization of Radiofrequency (RF) Coil       NEMA Standards Publication MS
                                 Heating in Magnetic Resonance Imaging Systems.     14-2019.
12-332........................  Magnetic resonance equipment for medical imaging-- IEC 62464-1 Edition 2.0 2018-
                                 Part 1: Determination of essential image quality   12.
                                 parameters.
12-333........................  Guidance on error and warning messages for         IEC TR 63183 Edition 1.0 2019-
                                 software used in radiotherapy.                     12.
12-334........................  Radiation therapy machine characterization.......  AAMI RT3:2020.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-115........................  Software and systems engineering--Software         ISO/IEC/IEEE 29119-1 First
                                 testing--Part 1: Concepts and definitions.         edition 2013-09-01.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-549........................  Standard Test Method for Evaluation of Seal        ASTM F3004--13[epsi]1.
                                 Quality and Integrity Using Airborne Ultrasound.
----------------------------------------------------------------------------------------------------------------
                                              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 
CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations 
should contain, at a minimum, the information listed on FDA's website, 
which is specifically available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

    Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04376 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P