[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Pages 24175-24181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08571]
[[Page 24175]]
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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: 057
AGENCY: Food and Drug Administration, Health and Human Services (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: 057'' (Recognition List Number: 057), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable April 22, 2022.
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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 057.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 057.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
An electronic copy of Recognition List Number: 057 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:
057 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: 057'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. Send one self-
addressed adhesive label to assist that office in processing your
request, or Fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition
[[Page 24176]]
program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the
initial list of recognized standards, as published in the Federal
Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains on its
website hypertext markup language (HTML) and portable document format
(PDF) versions of the list of FDA Recognized Consensus Standards,
available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. Additional
information on the Agency's Standards and Conformity Assessment Program
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 057
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: 057'' 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: 057.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-275.......... .............. ISO 10993-7 Second Title change.
edition 2008-10-15
Biological
evaluation of
medical devices--
Part 7: Ethylene
oxide sterilization
residuals
[Including:
Technical
Corrigendum 1
(2009), AMENDMENT 1:
Applicability of
allowable limits for
neonates and infants
(2019)].
2-284.......... 2-292 USP-NF M98833_01_01 Withdrawn and
<87> Biological replaced with
Reactivity Test, In newer version.
Vitro--Direct
Contact Test.
2-285.......... 2-293 USP-NF M98833_01_01 Withdrawn and
<87> Biological replaced with
Reactivity Test, In newer version.
Vitro--Elution Test.
2-286.......... 2-294 USP-NF M98834_01_01 Withdrawn and
<88> Biological replaced with
Reactivity Tests, In newer version.
Vivo.
2-287.......... 2-295 USP-NF M98900_01_01 Withdrawn and
<151> Pyrogen Test replaced with
(USP Rabbit Test).. newer version.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-88........... 3-171 ASTM F2514-21 Withdrawn and
Standard Guide for replaced with
Finite Element newer version.
Analysis (FEA) of
Metallic Vascular
Stents Subjected to
Uniform Radial
Loading.
3-99........... 3-172 AAMI TIR42:2021 Withdrawn and
Evaluation of replaced with
particulate newer version.
associated with
vascular medical
devices.
3-133.......... 3-173 ISO 5840-3 Second Withdrawn and
edition 2021-01 replaced with
Cardiovascular newer version.
implants--Cardiac
valve prostheses--
Part 3: Heart valve
substitutes
implanted by
transcatheter
techniques.
3-145.......... 3-174 ISO 5840-1 Second Withdrawn and
edition 2021-01 replaced with
Cardiovascular newer version.
implants--Cardiac
valve prostheses--
Part 1: General
requirements.
3-147.......... 3-175 ISO 5840-2 Second Withdrawn and
edition 2021-01 replaced with
Cardiovascular newer version.
implants--Cardiac
valve prostheses--
Part 2: Surgically
implanted heart
valve substitutes.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-89........... .............. ANSI/ADA Standard No. Withdrawn.
53--2008 (R2013)
Polymer-Based Crown
and Bridge Materials.
------------------------------------------------------------------------
4-282.......... 4-284 ISO 10873 Second Withdrawn and
edition 2021-07 replaced with
Dentistry--Denture newer version.
adhesives.
------------------------------------------------------------------------
[[Page 24177]]
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-117.......... 5-134 ISO 15223-1 Fourth Withdrawn and
edition 2021-07 replaced with
Medical devices-- newer version.
Symbols to be used
with medical device
labels, labelling,
and information to
be supplied--Part 1:
General requirements.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34.......... 19-41 ANSI/UL 61010-1 3rd Withdrawn and
Ed, dated May 12, replaced with
2012 with revision newer version.
through July 19,
2019 Standard for
Safety for
Electrical Equipment
For Measurement,
Control and
Laboratory Use; Part
1: General
Requirements.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-365.......... 6-464 ISO 11040-4 Third Withdrawn and
edition 2015-04-01 replaced with
Prefilled syringes-- newer version.
Part 4: Glass
barrels for
injectables and
sterilized
subassembled
syringes ready for
filling [Including
AMENDMENT 1 (2020)].
6-451.......... 6-465 USP-NF M76090_03_01 Withdrawn and
Sodium Chloride replaced with
Irrigation. newer version.
6-452.......... 6-466 USP-NF M76070_03_01 Withdrawn and
Sodium Chloride replaced with
Injection. newer version.
6-453.......... 6-467 USP-NF M80200_04_01 Withdrawn and
Nonabsorbable replaced with
Surgical Suture. newer version.
6-454.......... 6-468 USP-NF M99670_02_01 Withdrawn and
<881> Tensile replaced with
Strength. newer version.
6-455.......... 6-469 USP-NF M99650_02_01 Withdrawn and
<861> Sutures-- replaced with
Diameter. newer version.
6-456.......... 6-470 USP-NF M99660_03_01 Withdrawn and
<871> Sutures-- replaced with
Needle Attachment. newer version.
6-457.......... 6-471 USP-NF M88880_05_01 Withdrawn and
Sterile Water for replaced with
Irrigation. newer version.
6-458.......... 6-472 USP-NF M36660_04_01 Withdrawn and
Heparin Lock Flush replaced with
Solution.. newer version.
6-459.......... 6-473 USP-NF M80190_04_01 Withdrawn and
Absorbable Surgical replaced with
Suture. newer version.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-103.......... 8-563 ASTM F1801-20 Withdrawn and
Standard Practice replaced with
for Corrosion newer version.
Fatigue Testing of
Metallic Implant
Materials.
8-121.......... 8-564 ASTM F2005-21 Withdrawn and
Standard Terminology replaced with
for Nickel-Titanium newer version.
Shape Memory Alloys.
8-193.......... 8-565 ASTM F2754/F2754M-21 Withdrawn and
Standard Test Method replaced with
for Measurement of newer version.
Camber Cast Helix
and Direction of
Helix of Coiled Wire.
8-346.......... 8-566 ASTM F1813-21 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Titanium--12
Molybdenum--6
Zirconium--2 Iron
Alloy for Surgical
Implant (UNS R58120).
8-353.......... 8-567 ASTM F86-21 Standard Withdrawn and
Practice for Surface replaced with
Preparation and newer version.
Marking of Metallic
Surgical Implants.
8-355.......... 8-568 ASTM F1586-21 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Nitrogen
Strengthened 21
Chromium-10 Nickel-3
Manganese-2.5
Molybdenum Stainless
Steel Bar for
Surgical Implants
(UNS S31675).
8-385.......... 8-569 ASTM F648-21 Standard Withdrawn and
Specification for replaced with
Ultra-High-Molecular- newer version.
Weight Polyethylene
Powder and
Fabricated Form for
Surgical Implants.
8-398.......... 8-570 ASTM F1108-21 Withdrawn and
Standard replaced with
Specification for newer version.
Titanium-6Aluminum-
4Vanadium Alloy
Castings for
Surgical Implants.
8-422.......... 8-571 ASTM F2052-21 Withdrawn and
Standard Test Method replaced with
for Measurement of newer version.
Magnetically Induced
Displacement Force
on Medical Devices
in the Magnetic
Resonance
Environment.
8-423.......... 8-572 ASTM F2565-21 Withdrawn and
Standard Guide for replaced with
Extensively newer version.
Irradiation-
Crosslinked Ultra-
High Molecular
Weight Polyethylene
Fabricated Forms for
Surgical Implant
Applications.
8-424.......... 8-573 ASTM F2695-12(2020) Withdrawn and
Standard replaced with
Specification for newer version.
Ultra-High Molecular
Weight Polyethylene
Powder Blended With
Alpha-Tocopherol
(Vitamin E) and
Fabricated Forms for
Surgical Implant
Applications.
[[Page 24178]]
8-425.......... 8-574 ASTM F2820-12(2021)e1 Withdrawn and
Standard replaced with
Specification for newer version.
Polyetherketoneketon
e (PEKK) Polymers
for Surgical Implant
Applications.
8-443.......... 8-575 ASTM F3160-21 Withdrawn and
Standard Guide for replaced with
Metallurgical newer version.
Characterization of
Absorbable Metallic
Materials for
Medical Implants.
8-450.......... 8-576 ASTM F451-21 Standard Withdrawn and
Specification for replaced with
Acrylic Bone Cement. newer version.
8-456.......... 8-577 ISO 13179-1 Second Withdrawn and
Edition 2021-09 replaced with
Implants for newer version.
surgery--Coatings on Title change.
metallic surgical
implants--Part 1:
Plasma-sprayed
coatings derived
from titanium or
titanium-6 aluminum-
4 vanadium alloy
powders.
8-460.......... 8-578 ASTM F2848-21 Withdrawn and
Standard replaced with
Specification for newer version.
Medical-Grade Ultra-
High-Molecular-
Weight Polyethylene
Yarns.
8-515.......... 8-579 ISO 13779-3 Second Withdrawn and
Edition 2018-12 replaced with
Implants for newer version.
surgery--Hydroxyapat
ite--Part 3:
Chemical analysis
and characterization
of crystallinity
ratio and phase
purity [Including
AMENDMENT 1 (2021)].
------------------------------------------------------------------------
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
------------------------------------------------------------------------
10-73.......... 10-127 ANSI Z80.21-2020 Withdrawn and
American National replaced with
Standard for newer version.
Ophthalmics--Instrum
ents--General-
Purpose Clinical
Visual Acuity Charts.
10-87.......... 10-128 ASTM D882-18 Standard Withdrawn and
Test Method for replaced with
Tensile Properties newer version.
of Thin Plastic
Sheeting.
10-88.......... 10-129 ASTM D790-17 Standard Withdrawn and
Test Methods for replaced with
Flexural Properties newer version.
of Unreinforced and
Reinforced Plastics
and Electrical
Insulating Materials.
10-102......... 10-130 ANSI Z80.36-2021 Withdrawn and
American National replaced with
Standard for newer version.
Ophthalmics--Light
Hazard Protection
for Ophthalmic
Instruments.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-239......... 11-385 ASTM F2345-21 Withdrawn and
Standard Test replaced with
Methods for newer version.
Determination of
Cyclic Fatigue
Strength of Ceramic
Modular Femoral
Heads.
11-266......... 11-386 ASTM F2665-21 Withdrawn and
Standard replaced with
Specification for newer version.
Total Ankle
Replacement
Prosthesis.
11-305......... 11-387 ASTM F1781-21 Withdrawn and
Standard replaced with
Specification for newer version.
Elastomeric Flexible
Hinge Finger Total
Joint Implants.
11-345......... 11-388 ASTM F1717-21 Withdrawn and
Standard Test replaced with
Methods for Spinal newer version.
Implant Constructs
in a Vertebrectomy
Model.
11-359......... 11-389 ISO 7206-10 Second Withdrawn and
edition 2018-08 replaced with
Implants for newer version.
surgery--Partial and
total hip-joint
prostheses--Part 10:
Determination of
resistance to static
load of modular
femoral heads
[Including AMENDMENT
1 (2021)].
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-299......... 12-341 IEC 62563-1 Edition Withdrawn and
1.2 2021-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Medical
image display
systems--Part 1:
Evaluation methods.
12-300......... 12-342 NEMA DICOM PS 3.1-- Withdrawn and
3.20 2021e Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM) Set.
------------------------------------------------------------------------
[[Page 24179]]
Q. Software/Informatics
------------------------------------------------------------------------
13-46.......... .............. ASTM F2761-09 (2013) Withdrawn. See
Medical Devices and 13-120.
Medical Systems--
Essential safety
requirements for
equipment comprising
the patient-centric
integrated clinical
environment (ICE)--
Part 1: General
requirements and
conceptual model.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-424......... 14-563 ISO 13408-6 Second Withdrawn and
edition 2021-04 replaced with
Aseptic processing newer version.
of health care
products--Part 6:
Isolator systems.
14-555......... 14-564 USP-NF M98910_01_01 Withdrawn and
<161> Medical replaced with
Devices-Bacterial newer version.
Endotoxin and
Pyrogen Tests.
14-556......... 14-565 USP-NF M98802_01_01 Withdrawn and
<62> Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Tests for Specified
Microorganisms.
14-557......... 14-566 USP-NF M98795_02_01 Withdrawn and
<55> Biological replaced with
Indicators--Resistan newer version.
ce Performance Tests.
14-558......... 14-567 USP-NF M7414_01_01 Withdrawn and
<1229.5> Biological replaced with
Indicators for newer version.
Sterilization.
14-559......... 14-568 USP-NF M98800_01_01 Withdrawn and
<61> Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Microbial
Enumeration Tests.
14-560......... 14-569 USP-NF M98810_01_01 Withdrawn and
<71> Sterility Tests. replaced with
newer version.
14-561......... 14-570 USP-NF M98830_02_01 Withdrawn and
<85> Bacterial replaced with
Endotoxins Test. newer version.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
15-29.......... .............. ASTM F2259-10 Withdrawn.
(Reapproved 2012)e1
Standard Test Method
for Determining the
Chemical Composition
and Sequence in
Alginate by Proton
Nuclear Magnetic
Resonance (1H NMR)
Spectroscopy.
------------------------------------------------------------------------
\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: 057. 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
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-176................ Cardiovascular implants ISO 18193 First
and artificial organs-- edition 2021-08.
Cannulae for
extracorporeal
circulation.
3-177................ Standard Guide for Three- ASTM F2606-08
Point Bending of Balloon- (Reapproved 2021).
Expandable Vascular
Stents and Stent Systems.
3-178................ Standard Guide for Radial ASTM F3067-14
Loading of Balloon- (Reapproved 2021).
Expandable and Self-
Expanding Vascular Stents.
3-179................ Standard Guide for Design ASTM F3172-15
Verification Device Size (Reapproved 2021).
and Sample Size Selection
for Endovascular Devices.
3-180................ Standard Test Method for ASTM F3505-21.
Stent and Endovascular
Prosthesis Kink
Resistance.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-285................ Dental Abrasive Powders... ANSI/ADA Standard No.
37--1986 (R2020).
4-286................ Dental Impression Trays... ANSI/ADA Standard No.
87--1995 (R2014).
[[Page 24180]]
4-287................ Oral Rinses (Modified ANSI/ADA Standard No.
adoption of ISO 116--2020.
16408:2015, Dentistry
Oral Care Products--Oral
Rinses).
4-288................ Dentistry--Mixing machines ISO 7488 Second
for dental amalgam. edition 2018-04.
4-289................ Dentistry--Intraoral ISO 18556 First
spatulas. edition 2016-04.
4-290................ Dentistry--Integrated ISO 28158 Second
dental floss and handles. edition 2018-09.
4-291................ Dentistry--Products for ISO 28399 First
external tooth bleaching. edition 2011-01.
4-292................ Dentistry--Screening ISO 28888 First
method for erosion edition 2013-10.
potential of oral rinses
on dental hard tissues.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-42................ Electrical equipment for IEC 61326-1 Edition
measurement, control and 3.0 2020-10.
laboratory use--EMC
requirements--Part 1:
General requirements.
19-43................ Electrical equipment for IEC 61326-2-6 Edition
measurement, control and 3.0 2020-10.
laboratory use--EMC
requirements--Part 2-6:
Particular requirements--
In vitro diagnostic (IVD)
medical equipment.
19-44................ American National ANSI/IEEE C63.24-
Standard--Recommended 2021.
Practice for In Situ RF
Immunity Evaluation of
Electronic Devices and
Systems.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-474................ Standard Specification for ASTM F3352-19.
Isolation Gowns Intended
for Use in Healthcare
Facilities.
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-309................ Radiological protection-- ISO 17099 First
Performance criteria for edition 2014-11-15.
laboratories using the
cytokinesis block
micronucleus (CBMN) assay
in peripheral blood
lymphocytes for
biological dosimetry.
7-310................ Radiological protection-- ISO 19238 Second
Performance criteria for edition 2014-02-01.
service laboratories
performing biological
dosimetry by cytogenetics.
7-311................ A Hierarchical Approach to CLSI EP39, 1st
Selecting Surrogate Edition
Samples for the
Evaluation of In Vitro
Medical Laboratory Tests.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-580................ Eyewear display--Part 20- IEC 63145-20-10
10: Fundamental Edition 1.0 2019-08.
measurement methods--
Optical properties.
8-581................ Eyewear display--Part 20- IEC 63145-20-20
20: Fundamental Edition 1.0 2019-09.
measurement methods--
Image quality.
8-582................ Eyewear display--Part 22- IEC 63145-22-10
10: Specific measurement Edition 1.0 2020-01.
methods for AR type--
Optical properties.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-19................ Nanotechnologies--Measurem ISO 19749 First
ents of particle size and edition 2021-07.
shape distributions by
scanning electron
microscopy.
18-20................ Standard Guide for ASTM E3275-21.
Visualization and
Identification of
Nanomaterials in
Biological and
Nonbiological Matrices
Using Darkfield
Microscopy/Hyperspectral
Imaging (DFM/HSI)
Analysis.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
11-390............... Implants for surgery--Pre- ISO 23089-2 First
clinical mechanical edition 2021-05.
assessment of spinal
implants and particular
requirements--Part 2:
Spinal intervertebral
body fusion devices.
11-391............... Standard Practice for ASTM F2722-21.
Evaluating Mobile Bearing
Knee Tibial Baseplate
Rotational Stops.
11-392............... Standard Test Method for ASTM F2723-21.
Evaluating Mobile Bearing
Knee Tibial Baseplate/
Bearing Resistance to
Dynamic Disassociation.
[[Page 24181]]
11-393............... Standard Test Method for ASTM F2724-21.
Evaluating Mobile Bearing
Knee Dislocation.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-232............... Medical electrical IEC 80601-2-78
equipment--Part 2-78: Edition 1.0 2019-07.
Particular requirements
for basic safety and
essential performance of
medical robots for
rehabilitation,
assessment, compensation
or alleviation.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-120............... Medical Devices and ANSI/AAMI 2700-
Medical Systems-- 1:2019.
Essential safety
requirements for
equipment comprising the
patient-centric
integrated clinical
environment (ICE)--Part
1: General requirements
and conceptual model.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-571............... Sterilization of health ISO 11138-8 First
care products--Biological edition 2021-07.
indicators--Part 8:
Method for validation of
a reduced incubation time
for a biological
indicator.
------------------------------------------------------------------------
S. Tissue Engineering
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08571 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P