[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]
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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.
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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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
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
[email protected]. 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