Document ID: FDA-2004-N-0451-0047
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 053
Posted Date: 2020-03-30T04:00Z

[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17584-17592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06520]

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

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: 053

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: 053'' (Recognition List Number: 053), 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 30, 2020.

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:

[[Page 17585]]

     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: 053.'' 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. 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: 053.
     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.
    An electronic copy of Recognition List Number: 053 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: 
053 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: 053'' 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 
of the FD&C Act allows FDA to recognize consensus standards developed 
by international and national organizations for use in satisfying 
portions of device premarket review submissions or other requirements.
    In the Federal Register of September 14, 2018 (83 FR 46738), FDA 
announced the availability of a guidance entitled ``Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices.'' The guidance describes how FDA has implemented its standards 
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. 
Modifications to the initial list of recognized standards, as published 
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains a portable 
document format (PDF) version of the list of FDA Recognized Consensus 
Standards. 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: 053

    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: 053'' 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: 053.

[[Page 17586]]

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
    Old recognition No.      Replacement recognition No.      Title of standard \1\               Change
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-47.......................  ...........................  AS 4259-1995 Ancillary         Withdrawn.
                                                           devices for expired air
                                                           resuscitation.
1-102......................  ...........................  ISO 80601-2-69 First edition   Extent of Recognition.
                                                           2014-07-15 Medical
                                                           electrical equipment--Part 2-
                                                           69: Particular requirements
                                                           for basic safety and
                                                           essential performance of
                                                           oxygen concentrator
                                                           equipment.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-259......................  2-269......................  USP 42-NF37:2019 <87>          Withdrawn and replaced
                                                           Biological Reactivity Test,    with newer version.
                                                           In Vitro--Direct Contact
                                                           Test.
2-260......................  2-270......................  USP 42-NF37:2019 <87>          Withdrawn and replaced
                                                           Biological Reactivity Test,    with newer version.
                                                           In Vitro-Elution Test.
2-261......................  2-271......................  USP 42-NF37:2019 <88>          Withdrawn and replaced
                                                           Biological Reactivity Tests,   with newer version.
                                                           In Vivo.
2-262......................  2-272......................  USP 42-NF37:2019 <151>         Withdrawn and replaced
                                                           Pyrogen Test (USP Rabbit       with newer version.
                                                           Test).
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-139......................  3-161......................  ISO 14117 Second edition 2019- Withdrawn and replaced
                                                           09 Active implantable          with newer version.
                                                           medical devices--
                                                           Electromagnetic
                                                           compatibility--EMC test
                                                           protocols for implantable
                                                           cardiac pacemakers,
                                                           implantable cardioverter
                                                           defibrillators and cardiac
                                                           resynchronization devices.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-186......................  4-260......................  ANSI/ASA S12.2-2019 American   Withdrawn and replaced
                                                           National Standard Criteria     with newer version.
                                                           for Evaluating Room Noise.
4-212......................  4-261......................  ISO 7405 Third edition 2018-   Withdrawn and replaced
                                                           10 Corrected version 2018-12   with newer version.
                                                           Dentistry--Evaluation of
                                                           biocompatibility of medical
                                                           devices used in dentistry.
4-229......................  4-262......................  IEC 80601-2-60 Edition 2.0     Withdrawn and replaced
                                                           2019-06 Medical electrical     with newer version.
                                                           equipment--Part 2-60:
                                                           Particular requirements for
                                                           the basic safety and
                                                           essential performance of
                                                           dental equipment.
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-103......................  5-124......................  ISO 7000 Sixth edition 2019-   Withdrawn and replaced
                                                           07 Graphical symbols for use   with newer version.
                                                           on equipment--Registered
                                                           symbols.
5-40.......................  5-125......................  ISO 14971 Third edition 2019-  Withdrawn and replaced
                                                           12 Medical devices--           with newer version.
                                                           Application of risk
                                                           management to medical
                                                           devices.
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-13......................  ...........................  IEC 62133 Edition 2.0 2012-12  Transition removed.
                                                           Secondary cells and            Recognition restored.
                                                           batteries containing
                                                           alkaline or other non-acid
                                                           electrolytes--Safety
                                                           requirements for portable
                                                           sealed secondary cells, and
                                                           for batteries made from
                                                           them, for use in portable
                                                           applications [Including
                                                           CORRIGENDUM 1 (2013)].
19-32......................  ...........................  IEC 62133-1 Edition 1.0 2017-  Transition removed.
                                                           02 Secondary cells and
                                                           batteries containing
                                                           alkaline or other non-acid
                                                           electrolytes--Safety
                                                           requirements for portable
                                                           sealed secondary cells, and
                                                           for batteries made from
                                                           them, for use in portable
                                                           applications--Part 1: Nickel
                                                           systems.
19-33......................  ...........................  IEC 62133-2 Edition 2017-02    Transition removed.
                                                           Secondary cells and
                                                           batteries containing
                                                           alkaline or other non-acid
                                                           electrolytes--Safety
                                                           requirements for portable
                                                           sealed secondary cells, and
                                                           for batteries made from
                                                           them, for use in portable
                                                           applications--Part 2:
                                                           Lithium systems.
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-175......................  6-424......................  ASTM D5151-19 Standard Test    Withdrawn and replaced
                                                           Method for Detection of        with newer version.
                                                           Holes in Medical Gloves.
6-254......................  6-425......................  ASTM F2100-19 Standard         Withdrawn and replaced
                                                           Specification for              with newer version.
                                                           Performance of Materials
                                                           Used in Medical Face Masks.
6-293......................  6-426......................  ISO 23907-1 First edition      Withdrawn and replaced
                                                           2019-01 Sharps injury          with newer version.
                                                           protection--Requirements and
                                                           test methods--Part 1: Single-
                                                           use sharps containers.
6-335......................  6-427......................  ASTM F2101-19 Standard Test    Withdrawn and replaced
                                                           Method for Evaluating the      with newer version.
                                                           Bacterial Filtration
                                                           Efficiency (BFE) of Medical
                                                           Face Mask Materials, Using a
                                                           Biological Aerosol of
                                                           Staphylococcus aureus.
6-412......................  6-428......................  USP 42-NF37:2019 Sodium        Withdrawn and replaced
                                                           Chloride Irrigation.           with newer version.

[[Page 17587]]

 
6-413......................  6-429......................  USP 42-NF37:2019 Sodium        Withdrawn and replaced
                                                           Chloride Injection.            with newer version.
6-414......................  6-430......................  USP 42-NF37:2019               Withdrawn and replaced
                                                           Nonabsorbable Surgical         with newer version.
                                                           Suture.
6-415......................  6-431......................  USP 42-NF37:2019 <881>         Withdrawn and replaced
                                                           Tensile Strength.              with newer version.
6-416......................  6-432......................  USP 42-NF37:2019 <861>         Withdrawn and replaced
                                                           Sutures--Diameter.             with newer version.
6-417......................  6-433......................  USP 42-NF37:2019 <871>         Withdrawn and replaced
                                                           Sutures--Needle Attachment.    with newer version.
6-418......................  6-434......................  USP 42-NF37:2019 Sterile       Withdrawn and replaced
                                                           Water for Irrigation.          with newer version.
6-419......................  6-435......................  USP 42-NF37:2019 Heparin Lock  Withdrawn and replaced
                                                           Flush Solution.                with newer version.
6-420......................  6-436......................  USP 42-NF37:2019 Absorbable    Withdrawn and replaced
                                                           Surgical Suture.               with newer version.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-226......................  7-293......................  CLSI QMS01, 5th ed. June 2019  Withdrawn and replaced
                                                           (Replaces QMS01-A4) A          with newer version.
                                                           Quality Management System
                                                           Model for Laboratory
                                                           Services.
7-281......................  7-294......................  CLSI M100, 29th ed. January    Withdrawn and replaced
                                                           2019 (Replaces M100 28th       with newer version.
                                                           ed.) Performance Standards
                                                           for Antimicrobial
                                                           Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-68.......................  8-519......................  ISO 13782 Second edition 2019- Withdrawn and replaced
                                                           04 Implants for surgery--      with newer version.
                                                           Metallic materials--
                                                           Unalloyed tantalum for
                                                           surgical implant
                                                           applications.
8-218......................  8-520......................  F799-19 Standard               Withdrawn and replaced
                                                           Specification for Cobalt-28    with newer version.
                                                           Chromium-6 Molybdenum Alloy
                                                           Forgings for Surgical
                                                           Implants (UNS R31537,
                                                           R31538, R31539).
8-391......................  8-521......................  F2313-18 Standard              Withdrawn and replaced
                                                           Specification for              with newer version.
                                                           Poly(glycolide) and
                                                           Poly(glycolide-co-lactide)
                                                           Resins for Surgical Implants
                                                           with Mole Fractions Greater
                                                           Than or Equal to 70%
                                                           Glycolide.
8-477......................  8-522......................  F2129-19a Standard Test        Withdrawn and replaced
                                                           Method for Conducting Cyclic   with newer version.
                                                           Potentiodynamic Polarization
                                                           Measurements to Determine
                                                           the Corrosion Susceptibility
                                                           of Small Implant Devices.
8-480......................  ...........................  ASTM F2063-18 Standard         Transition period
                                                           Specification for Wrought      extended.
                                                           Nickel-Titanium Shape Memory
                                                           Alloys for Medical Devices
                                                           and Surgical Implants.
8-481......................  ...........................  ASTM F1314-18 Standard         Transition period
                                                           Specification for Wrought      extended.
                                                           Nitrogen Strengthened 22
                                                           Chromium-13 Nickel-5
                                                           Manganese-2.5 Molybdenum
                                                           Stainless Steel Alloy Bar
                                                           and Wire for Surgical
                                                           Implants (UNS S20910).
8-484......................  ...........................  ASTM F2066-18 Standard         Transition period
                                                           Specification for Wrought      extended.
                                                           Titanium-15 Molybdenum Alloy
                                                           for Surgical Implant
                                                           Applications (UNS R58150).
8-491......................  ...........................  ASTM F1088-18 Standard         Transition period
                                                           Specification for Beta-        extended.
                                                           Tricalcium Phosphate for
                                                           Surgical Implantation.
8-492......................  ...........................  ISO 5832-9 Third edition 2019- Transition period
                                                           02 Implants for surgery--      extended.
                                                           Metallic materials--Part 9:
                                                           Wrought high nitrogen
                                                           stainless steel.
8-494......................  ...........................  ISO 6474-1 Second edition      Transition period
                                                           2019-03 Implants for           extended.
                                                           surgery--Ceramic materials--
                                                           Part 1: Ceramic materials
                                                           based on high purity alumina.
8-498......................  ...........................  ASTM F75-18 Standard           Transition period
                                                           Specification for Cobalt-28    extended.
                                                           Chromium-6 Molybdenum Alloy
                                                           Castings and Casting Alloy
                                                           for Surgical Implants (UNS
                                                           R30075).
8-499......................  ...........................  ASTM F1580-18 Standard         Transition period
                                                           Specification for Titanium     extended.
                                                           and Titanium-6 Aluminum-4
                                                           Vanadium Alloy Powders for
                                                           Coatings of Surgical
                                                           Implants.
8-500......................  ...........................  ISO 5832-12 Third edition      Transition period
                                                           2019-02 Implants for           extended.
                                                           surgery--Metallic materials--
                                                           Part 12: Wrought cobalt-
                                                           chromium-molybdenum alloy.
8-501......................  ...........................  ISO 5834-1 Fourth edition      Transition period
                                                           2019-02 Implants for           extended.
                                                           surgery--Ultra-high-
                                                           molecular-weight
                                                           polyethylene--Part 1: Powder
                                                           form.
8-502......................  ...........................  ASTM F2038-18 Standard Guide   Transition period
                                                           for Silicone Elastomers,       extended.
                                                           Gels, and Foams Used in
                                                           Medical Applications Part I--
                                                           Formulations and Uncured
                                                           Materials.
8-505......................  ...........................  ISO 6474-2 Second edition      Transition period
                                                           2019-03 Implants for           extended.
                                                           surgery--Ceramic materials--
                                                           Part 2: Composite materials
                                                           based on a high-purity
                                                           alumina matrix with zirconia
                                                           reinforcement.
8-507......................  ...........................  ASTM F688-19 Standard          Transition period
                                                           Specification for Wrought      extended.
                                                           Cobalt-35Nickel-20Chromium-
                                                           10Molybdenum Alloy Plate,
                                                           Sheet, and Foil for Surgical
                                                           Implants (UNS R30035).

[[Page 17588]]

 
8-508......................  ...........................  ASTM F2579-18 Standard         Transition period
                                                           Specification for Amorphous    extended.
                                                           Poly(lactide) and
                                                           Poly(lactide-co-glycolide)
                                                           Resins for Surgical Implants.
8-511......................  ...........................  ASTM F1925-17 Standard         Withdrawn. Duplicate
                                                           Specification for Semi-        recognition. See 8-
                                                           Crystalline Poly(lactide)      471.
                                                           Polymer and Copolymer Resins
                                                           for Surgical Implants.
8-512......................  ...........................  ASTM F2026-17 Standard         Withdrawn. Duplicate
                                                           Specification for              recognition. See 8-
                                                           Polyetheretherketone (PEEK)    475.
                                                           Polymers for Surgical
                                                           Implant 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)
----------------------------------------------------------------------------------------------------------------
9-84.......................  9-123......................  ISO 8600-3 Second edition      Withdrawn and replaced
                                                           2019-08 Endoscopes--Medical    with newer version.
                                                           endoscopes and endotherapy
                                                           devices--Part 3:
                                                           Determination of field of
                                                           view and direction of view
                                                           of endoscopes with optics.
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
                                                          No new entries at this time..
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-328.....................  11-360.....................  ASTM F1378-18 [egr]1 Standard  Withdrawn and replaced
                                                           Specification for Shoulder     with newer version.
                                                           Prostheses.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-168.....................  16-207.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           1: Determination of static
                                                           stability.
16-169.....................  16-208.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 2:
                                                           Determination of dynamic
                                                           stability of electrically
                                                           powered wheelchairs.
16-170.....................  16-209.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           3: determination of
                                                           effectiveness of brakes.
16-171.....................  16-210.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 4 Energy
                                                           consumption of electrically
                                                           powered wheelchairs and
                                                           scooters for determination
                                                           of theoretical distance
                                                           range.
16-172.....................  16-211.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           5: Determination of
                                                           dimensions, mass and
                                                           maneuvering space.
16-173.....................  16-212.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 6:
                                                           Determination of maximum
                                                           speed of electrically
                                                           powered wheelchairs.
16-174.....................  16-213.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           7: Method of measurement of
                                                           seating and wheel dimensions.
16-175.....................  16-214.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           8: Requirements and test
                                                           methods for static, impact
                                                           and fatigue strengths.
16-176.....................  16-215.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 9: Climatic
                                                           tests for electrically
                                                           powered wheelchairs.

[[Page 17589]]

 
16-177.....................  16-216.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 10:
                                                           Determination of obstacle-
                                                           climbing ability of
                                                           electrically powered
                                                           wheelchairs.
16-178.....................  16-217.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           11: Test mannequins.
16-179.....................  16-218.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           13: Determination of
                                                           coefficient of friction of
                                                           test surfaces.
16-180.....................  16-219.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 14: Power
                                                           and control systems for
                                                           electrically powered
                                                           wheelchairs, scooters and
                                                           add-on devices--Requirements
                                                           and test methods.
16-181.....................  16-220.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           15: Requirements for
                                                           information disclosure,
                                                           documentation and labeling.
16-182.....................  16-221.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           16: Resistance to ignition
                                                           of postural support devices.
16-183.....................  16-222.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           20: Determination of the
                                                           performance of stand-up type
                                                           wheelchairs.
16-184.....................  16-223.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           22: Set-up procedures.
16-185.....................  16-224.....................  ANSI/RESNA WC-2:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 2:
                                                           Additional Requirements for
                                                           Wheelchairs (including
                                                           Scooters) with Electrical
                                                           Systems Section 21:
                                                           Requirements and test
                                                           methods for electromagnetic
                                                           compatibility of
                                                           electrically powered
                                                           wheelchairs and scooters,
                                                           and battery chargers.
16-187.....................  16-225.....................  ANSI/RESNA WC-1:2019 American  Withdrawn and replaced
                                                           National Standard for          with a newer version.
                                                           Wheelchairs--Volume 1:
                                                           Requirements and Test
                                                           Methods for Wheelchairs
                                                           (including Scooters) Section
                                                           26: Vocabulary.
16-205.....................  ...........................  ANSI/RESNA W-4:2017 American   Withdrawn. See 16-226,
                                                           National Standard for          16-227, 16-228, and 16-
                                                           Wheelchairs--Volume 4:         229.
                                                           Wheelchairs and
                                                           Transportation.
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-110.....................  12-327.....................  ISO 11551 Third edition 2019-  Withdrawn and replaced
                                                           10 Optics and optical          with newer version.
                                                           instruments--Lasers and
                                                           laser-related equipment--
                                                           Test method for absorptance
                                                           of optical laser components.
12-270.....................  12-328.....................  IEC 61223-3-5 Edition 2.0      Withdrawn and replaced
                                                           2019-09 Evaluation and         with newer version.
                                                           routine testing in medical
                                                           imaging departments--Part 3-
                                                           5: Acceptance tests--Imaging
                                                           performance of computed
                                                           tomography X-ray equipment.
12-308.....................  12-329.....................  IEC 60601-2-43 Edition 2.2     Withdrawn and replaced
                                                           2019-10 CONSOLIDATED VERSION   with newer version.
                                                           Medical electrical
                                                           equipment--Part 2-43:
                                                           Particular requirements for
                                                           the basic safety and
                                                           essential performance of X-
                                                           ray equipment for
                                                           interventional procedures.
12-309.....................  ...........................  IEC 60601-2-28 Edition 3.0     Transition period
                                                           2017-06 Medical electrical     extended.
                                                           equipment--Part 2-28:
                                                           Particular requirements for
                                                           the basic safety and
                                                           essential performance of X-
                                                           ray tube assemblies for
                                                           medical diagnosis.
12-317.....................  ...........................  IEC 60601-2-54 Edition 1.1     Transition period
                                                           2015-04 CONSOLIDATED VERSION   extended.
                                                           Medical electrical
                                                           equipment--Part 2-54:
                                                           Particular requirements for
                                                           the basic safety and
                                                           essential performance of X-
                                                           ray equipment for
                                                           radiography and radioscopy
                                                           [Including AMENDMENT 2
                                                           (2018)].
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-47......................  13-110.....................  ISO/IEEE 11073-10101 First     Withdrawn and replaced
                                                           edition 2004-12-15 Health      with newer version
                                                           informatics--Point-of-care     including amendment.
                                                           medical device
                                                           communication--Part 10101:
                                                           Nomenclature [Including
                                                           AMENDMENT 1 (2017)].
13-48......................  13-111.....................  IEEE Std 11073-10201-2018      Withdrawn and replaced
                                                           Health informatics--Point-of-  with newer version.
                                                           care medical device
                                                           communication Part 10201:
                                                           Domain Information Model.
----------------------------------------------------------------------------------------------------------------

[[Page 17590]]

 
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-325.....................  14-528.....................  ISO 11139 First edition 2018-  Withdrawn and replaced
                                                           08 Sterilization of health     with newer version.
                                                           care products--Vocabulary of
                                                           terms used in sterilization
                                                           and related equipment and
                                                           process standards.
14-354.....................  14-529.....................  ISO 18472 Second edition 2018- Withdrawn and replaced
                                                           08 Sterilization of health     with newer version.
                                                           care products--Biological
                                                           and chemical indicators--
                                                           Test equipment.
14-382.....................  14-530.....................  ISO/ASTM 51276 Fourth edition  Withdrawn and replaced
                                                           2019-08 Practice for use of    with newer version.
                                                           a polymethylmethacrylate
                                                           dosimetry system.
14-520.....................  14-531.....................  USP 42-NF37:2019 <61>          Withdrawn and replaced
                                                           Microbiological Examination    with newer version.
                                                           of Nonsterile Products:
                                                           Microbial Enumeration Tests.
14-521.....................  14-532.....................  USP 42-NF37:2019 <71>          Withdrawn and replaced
                                                           Sterility Tests.               with newer version.
14-522.....................  14-533.....................  USP 42-NF37:2019 <85>          Withdrawn and replaced
                                                           Bacterial Endotoxins Test.     with newer version.
14-523.....................  14-534.....................  USP 42-NF37:2019 <161>         Withdrawn and replaced
                                                           Medical Devices-Bacterial      with newer version.
                                                           Endotoxin and Pyrogen Tests.
14-524.....................  14-535.....................  USP 42-NF37:2019 <62>          Withdrawn and replaced
                                                           Microbiological Examination    with newer version.
                                                           of Nonsterile Products:
                                                           Tests for Specified
                                                           Microorganisms.
14-525.....................  14-536.....................  USP 42-NF37:2019 <55>          Withdrawn and replaced
                                                           Biological Indicators--        with newer version.
                                                           Resistance Performance Tests.
14-526.....................  14-537.....................  USP 42-NF37:2019 <1229.5>      Withdrawn and replaced
                                                           Biological Indicators for      with newer version.
                                                           Sterilization.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
                                                          No new entries at this time..
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 053. These entries are of standards not 
previously recognized by FDA.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-145..................  Lung ventilators and       ISO 19223 First
                          related equipment--        edition 2019-07.
                          Vocabulary and semantics.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
                         No new entries at this
                          time.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-162..................  Standard Guide for Active  ASTM F3374-19.
                          Fixation Durability of
                          Endovascular Prostheses.
3-163..................  Cardiovascular implants    ISO 18242 First
                          and extracorporeal         edition 2016-09-01.
                          systems--Centrifugal
                          blood pumps.
------------------------------------------------------------------------
                  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)
------------------------------------------------------------------------
6-437..................  Sharps injury protection-- ISO 23907-2 First
                          Requirements and test      edition 2019-11.
                          methods--Part 2:
                          Reusable sharps
                          containers.

[[Page 17591]]

 
6-438..................  Medical electrical         IEC 80601-2-77
                          equipment--Part 2-77:      Edition 1.0 2019-
                          Particular requirements    07.
                          for the BASIC SAFETY and
                          essential performance of
                          ROBOTICALLY ASSISTED
                          SURGICAL EQUIPMENT.
------------------------------------------------------------------------
                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-295..................  Verification of            CLSI M52, 1st ed.
                          Commercial Microbial       August 2015.
                          Identification and
                          Antimicrobial
                          Susceptibility Testing
                          Systems.
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-523..................  Standard Guide for Using   ASTM F3275-19.
                          a Force Tester to
                          Evaluate Performance of
                          a Brush Part Designed to
                          Clean the Internal
                          Channel of a Medical
                          Device.
8-524..................  Standard Guide for Using   ASTM F3276-19.
                          a Force Tester to
                          Evaluate the Performance
                          of a Brush Part Designed
                          to Clean the External
                          Surface of a Medical
                          Device.
------------------------------------------------------------------------
                            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
------------------------------------------------------------------------
11-361.................  Implants for surgery--     ISO 14243-5 First
                          Wear of total knee         edition 2019-05.
                          prostheses--Part 5:
                          Durability performance
                          of the patellofemoral
                          joint.
11-362.................  Implants for surgery--     ISO 22622 First
                          Wear of total ankle-       edition 2019-07.
                          joint prostheses--
                          Loading and displacement
                          parameters for wear-
                          testing machines with
                          load or displacement
                          control and
                          corresponding
                          environmental conditions
                          for test.
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-226.................  American National          ANSI/RESNA WC-4:2017
                          Standard for               Section 10.
                          Wheelchairs--Volume 4:
                          Wheelchairs and
                          Transportation Section
                          10 Wheelchair
                          containment and occupant
                          retention systems for
                          use in large accessible
                          transit vehicles:
                          systems for rearward-
                          facing passengers.
16-227.................  American National          ANSI/RESNA WC-4:2017
                          Standard for               Section 18.
                          Wheelchairs--Volume 4:
                          Wheelchairs and
                          Transportation Section
                          18: Wheelchair tiedown
                          and occupant restraint
                          systems for use in motor
                          vehicles.
16-228.................  ANSI/RESNA W-4:2017        ANSI/RESNA WC-4:2017
                          American National          Section 19.
                          Standard for
                          Wheelchairs--Volume 4:
                          Wheelchairs and
                          Transportation Section
                          19: Wheelchairs used as
                          seats in motor vehicles.
16-229.................  American National          ANSI/RESNA WC-4:2017
                          Standard for               Section 20.
                          Wheelchairs--Volume 4:
                          Wheelchairs and
                          Transportation Section
                          20: Wheelchair seating
                          systems for use in motor
                          vehicles.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                         No new entries at this
                          time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-112.................  Principles for medical     AAMI TIR97:2019.
                          device security--
                          Postmarket risk
                          management for device
                          manufacturers.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
14-538.................  Standard Guide for         ASTM F3357-19.
                          Designing Reusable
                          Medical Devices for
                          Cleanability.
------------------------------------------------------------------------
                          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.

[[Page 17592]]

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/standards-and-conformity-assessment-program/recognition-standard.

    Dated: March 24, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06520 Filed 3-27-20; 8:45 am]
 BILLING CODE 4164-01-P