[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57034-57041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23198]
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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: 052
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: 052'' (Recognition List Number: 052), 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 October 24, 2019.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 052.'' 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
[[Page 57035]]
modifications to the list of recognized standards, Recognition List
Number: 052.
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.gpo.gov/fdsys/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: 052 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:
052 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: 052'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg.
66, Rm. 5514, 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. 5514, Silver Spring, MD 20993, 301-796-6287,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514
allows FDA to recognize consensus standards developed by international
and national organizations for use in satisfying portions of device
premarket review submissions or other requirements.
In the Federal Register of September 14, 2018 (83 FR 46738), FDA
announced the availability of a guidance entitled ``Appropriate Use of
Voluntary Consensus Standards in Premarket Submissions for Medical
Devices.'' The guidance describes how FDA has implemented its standards
recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices.
Modifications to the initial list of recognized standards, as published
in the Federal Register, can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language (HTML) and portable document format (PDF) versions 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: 052
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: 052'' 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: 052.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Old Recognition No. Replacement Recognition No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-116...................... ........................... ISO 5360 Fourth edition 2016- Extent of Recognition.
02-15 Anaesthetic
vaporizers--Agent specific
filling systems.
1-122...................... ........................... ISO 5364 Fifth edition 2016- Extent of Recognition.
09-01 Anaesthetic and
respiratory equipment--
Oropharyngeal airways.
1-125...................... ........................... ISO 8836 Fourth edition 2014- Extent of Recognition.
10-15 Suction catheters for
use in the respiratory tract.
[[Page 57036]]
1-126...................... ........................... ISO 11712 First edition 2009- Extent of Recognition.
05-15 Anaesthetic and
respiratory equipment--
Supralaryngeal airways and
connectors.
1-131...................... 1-142...................... ISO 10079-1 Third Edition Withdrawn and replaced
2015-11-01 Medical suction with newer version
equipment--Part 1: including amendment.
Electrically powered suction
equipment [Including
AMENDMENT 1 (2018)].
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-162...................... 2-263...................... ASTM F1903-18 Standard Withdrawn and replaced
Practice for Testing for with newer version.
Cellular Responses to
Particles in vitro.
2-206...................... 2-264...................... ASTM F2148-18 Standard Withdrawn and replaced
Practice for Evaluation of with newer version.
Delayed Contact
Hypersensitivity Using the
Murine Local Lymph Node
Assay (LLNA).
2-223...................... 2-265...................... ASTM F2901-19 Standard Guide Withdrawn and replaced
for Selecting Tests to with newer version.
Evaluate Potential
Neurotoxicity of Medical
Devices.
2-257...................... 2-266...................... ASTM F2382-18 Standard Test Withdrawn and replaced
Method for Assessment of with newer version.
Circulating Blood-Contacting
Medical Device Materials on
Partial Thromboplastin Time
(PTT).
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-122...................... 3-160...................... ISO 81060-2 Third edition Withdrawn and replaced
2018-11 Non-invasive with newer version.
sphygmomanometers--Part 2:
Clinical investigation of
intermittent automated
measurement type.
3-123...................... ........................... IEC 80601-2-30 Edition 2.0 Extent of Recognition.
2018-03 Medical electrical
equipment--Part 2-30:
Particular requirements for
the basic safety and
essential performance of
automated non-invasive
sphygmomanometers.
3-137...................... ........................... ASTM F3036-13 Standard Guide Extent of Recognition.
for Testing Absorbable
Stents.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-182...................... 4-258...................... ISO 10139-2 Third edition Withdrawn and replaced
2016-06-15 Dentistry--Soft with newer version.
lining materials for
removable dentures--Part 2:
Materials for long-term use.
4-196...................... ........................... ISO 6872 Third edition 2008- Withdrawn. See #4-223.
09-01 Dentistry--Ceramic
materials.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-109...................... 5-123...................... ISO 80369-3 First edition Withdrawn and replaced
2016-07-01 Small-bore with newer version
connectors for liquids and including amendment.
gases in healthcare
applications --Part 3:
Connectors for enteral
applications [Including
AMENDMENT 1 (2019)].
5-115...................... ........................... ISO 80369-7 First edition Transition removed.
2016-10-15 Small-bore
connectors for liquids and
gases in healthcare
applications--Part 7:
Connectors for intravascular
or hypodermic applications.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-11....................... ........................... ISO 594-1 First edition 1986- Transition removed.
06-15 Conical fittings with Recognition restored.
a 6% (Luer) taper for
syringes, needles and
certain other medical
equipment--Part 1: General
requirements.
----------------------------------------------------------------------------------------------------------------
6-129...................... ........................... ISO 594-2 Second edition 1998- Transition removed.
09-01 Conical fittings with Recognition restored.
a 6% (Luer) taper for
syringes, needles and
certain other medical
equipment--Part 2: Lock
fittings.
6-403...................... 6-421...................... ISO 80601-2-56 Second edition Withdrawn and replaced
2017-03 Medical electrical with newer version
equipment--Part 2-56: including amendment.
Particular requirements for
basic safety and essential
performance of clinical
thermometers for body
temperature measurement
[Including AMENDMENT 1
(2018)].
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-215...................... 7-287...................... CLSI M44-S3 (2018) Zone Withdrawn and replaced
Diameter Interpretive with newer version.
Standards, Corresponding
Minimal Inhibitory
Concentration (MIC)
Interpretive Breakpoints,
and Quality Control Limits
for Antifungal Disk
Diffusion Susceptibility
Testing of Yeasts; Third
Informational Supplement.
7-222...................... 7-288...................... CLSI M24 3rd Edition Withdrawn and replaced
Susceptibility Testing of with newer version.
Mycobacteria, Nocardia spp.,
and Other Aerobic
Actinomycetes.
[[Page 57037]]
7-274...................... 7-289...................... CLSI MM17 2nd Edition Withdrawn and replaced
Validation and Verification with newer version.
of Multiplex Nucleic Acid
Assays.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-132...................... 8-491...................... ASTM F1088-18 Standard Withdrawn and replaced
Specification for Beta- with newer version.
Tricalcium Phosphate for
Surgical Implantation.
8-150...................... 8-492...................... ISO 5832-9 Third edition 2019- Withdrawn and replaced
02 Implants for surgery-- with newer version.
Metallic materials--Part 9:
Wrought high nitrogen
stainless steel.
8-188...................... 8-493...................... ISO 13779-2 Third edition Withdrawn and replaced
2018-12 Implants for with newer version.
surgery--Hydroxyapatite--Par
t 2: Thermally sprayed
coatings of hydroxyapatite.
8-194...................... 8-494...................... ISO 6474-1 Second edition Withdrawn and replaced
2019-03 Implants for with newer version.
surgery--Ceramic materials--
Part 1: Ceramic materials
based on high purity alumina.
8-213...................... 8-495...................... ISO 5834-3 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 3:
Accelerated ageing methods.
8-214...................... 8-496...................... ISO 5834-4 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 4:
Oxidation index measurement
method.
8-215...................... 8-497...................... ISO 5834-5 Second edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 5:
Morphology assessment method.
8-229...................... 8-498...................... ASTM F75-18 Standard Withdrawn and replaced
Specification for Cobalt-28 with newer version.
Chromium-6 Molybdenum Alloy
Castings and Casting Alloy
for Surgical Implants (UNS
R30075).
8-331...................... 8-499...................... ASTM F1580-18 Standard Withdrawn and replaced
Specification for Titanium with newer version.
and Titanium-6 Aluminum-4
Vanadium Alloy Powders for
Coatings of Surgical
Implants.
8-351...................... 8-500...................... ISO 5832-12 Third edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Metallic materials--
Part 12: Wrought cobalt-
chromium-molybdenum alloy.
8-352...................... 8-501...................... ISO 5834-1 Fourth edition Withdrawn and replaced
2019-02 Implants for with newer version.
surgery--Ultra-high-
molecular-weight
polyethylene--Part 1: Powder
form.
8-359...................... 8-502...................... ASTM F2038--18 Standard Guide Withdrawn and replaced
for Silicone Elastomers, with newer version.
Gels, and Foams Used in
Medical Applications Part I--
Formulations and Uncured
Materials.
8-360...................... 8-503...................... ASTM F2042-18 Standard Guide Withdrawn and replaced
for Silicone Elastomers, with newer version.
Gels, and Foams Used in
Medical Applications Part
II--Crosslinking and
Fabrication.
8-370...................... 8-504...................... ASTM F561-19 Standard Withdrawn and replaced
Practice for Retrieval and with newer version.
Analysis of Medical Devices,
and Associated Tissues and
Fluids.
8-388...................... 8-505...................... ISO 6474-2 Second edition Withdrawn and replaced
2019-03 Implants for with newer version.
surgery--Ceramic materials--
Part 2: Composite materials
based on a high-purity
alumina matrix with zirconia
reinforcement.
8-397...................... 8-506...................... ASTM F2516-18 Standard Test Withdrawn and replaced
Method for Tension Testing with newer version.
of Nickel-Titanium
Superelastic Materials.
8-402...................... 8-507...................... ASTM F688-19 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Cobalt-35Nickel-20Chromium-
10Molybdenum Alloy Plate,
Sheet, and Foil for Surgical
Implants (UNS R30035).
8-411...................... 8-508...................... ASTM F2579-18 Standard Withdrawn and replaced
Specification for Amorphous with newer version.
Poly(lactide) and
Poly(lactide-co-glycolide)
Resins for Surgical Implants.
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
10-89...................... ........................... ANSI Z80.7-2013 (R2018) Extent of recognition.
American National Standard
for Ophthalmic Optics--
Intraocular Lenses.
----------------------------------------------------------------------------------------------------------------
[[Page 57038]]
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-250..................... 11-349..................... ISO 14242-3 First edition Withdrawn and replaced
2009-03-15 Implants for with newer version.
surgery--Wear of total hip-
joint prostheses--Part 3:
Loading and displacement
parameters for orbital
bearing type wear testing
machines and corresponding
environmental conditions for
test [Including AMENDMENT 1
(2019)].
11-251..................... 11-350..................... ASTM F2554-18 Standard Withdrawn and replaced
Practice for Measurement of with newer version.
Positional Accuracy of
Computer Assisted Surgical
Systems.
11-273..................... 11-351..................... ISO 18192-1 Second edition Withdrawn and replaced
2011-03-01 Implants for with newer version.
surgery--Wear of total
intervertebral spinal disc
prostheses--Part 1: Loading
and displacement parameters
for wear testing and
corresponding environmental
conditions for test
[Including AMENDMENT 1
(2018)].
11-291..................... 11-352..................... ISO 14242-1 Third edition Withdrawn and replaced
2014-10-15 Implants for with newer version
surgery--Wear of total hip- including amendment.
joint prostheses --Part 1:
Loading and displacement
parameters for wear-testing
machines and corresponding
environmental conditions for
test [Including AMENDMENT 1
(2018)].
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-225..................... 12-325..................... NEMA XR 25-2019 Computed Withdrawn and replaced
Tomography Dose Check. with newer version.
----------------------------------------------------------------------------------------------------------------
12-265..................... 12-326..................... NEMA NU 2-2018 Performance Withdrawn and replaced
Measurements of Positron with newer version.
Emission Tomographs (PETS).
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
No new entries at this time..
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-377..................... 14-527..................... ASTM F2638-18 Standard Test Withdrawn and replaced
Method for Using Aerosol with newer version.
Filtration for Measuring the
Performance of Porous
Packaging Materials as a
Surrogate Microbial Barrier.
----------------------------------------------------------------------------------------------------------------
14-428..................... 14-528..................... ISO 11137-1 First edition Withdrawn and replaced
2006-04-15 Sterilization of with newer version
health care products-- including amendment.
Radiation--Part 1:
Requirements for
development, validation and
routine control of a
sterilization process for
medical devices [Including
AMENDMENT 1 (2013) and
AMENDMENT 2 (2018)].
14-452..................... 14-529..................... ISO 11135 Second edition 2014- Withdrawn and replaced
07-15 Sterilization of with newer version
health-care products-- including amendment.
Ethylene oxide--Requirements
for the development,
validation and routine
control of a sterilization
process for medical devices
[Including: AMENDMENT 1
(2018)].
14-454..................... 14-530..................... ISO 11607-1 Second edition Withdrawn and replaced
2019-02 Packaging for with newer version.
terminally sterilized
medical devices--Part 1:
Requirements for materials,
sterile barrier systems and
packaging systems.
14-455..................... 14-531..................... ISO 11607-2 Second edition Withdrawn and replaced
2019-02 Packaging for with newer version.
terminally sterilized
medical devices--Part 2:
Validation requirements for
forming, sealing and
assembly processes.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-27...................... 15-57...................... F2315-18 Standard Guide for Withdrawn and replaced
Immobilization or with newer version.
Encapsulation of Living
Cells or Tissue in Alginate
Gels.
----------------------------------------------------------------------------------------------------------------
15-28...................... 15-58...................... F2103-18 Standard Guide for Withdrawn and replaced
Characterization and Testing with newer version.
of Chitosan Salts as
Starting Materials Intended
for Use in Biomedical and
Tissue-Engineered Medical
Product Applications.
----------------------------------------------------------------------------------------------------------------
\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: 052. These entries are of standards not
previously recognized by FDA.
[[Page 57039]]
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-143.................. Medical electrical ISO 80601-2-79 First
equipment--Part 2-79: edition 2018-07.
Particular requirements
for basic safety and
essential performance of
ventilatory support
equipment for
ventilatory impairment.
1-144.................. Medical electrical ISO 80601-2-80 First
equipment--Part 2-80: edition 2018-07.
Particular requirements
for basic safety and
essential performance of
ventilatory support
equipment for
ventilatory
insufficiency.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-267.................. Standard Practice for ASTM F2888--19.
Platelet Leukocyte
Count--An In-Vitro
Measure for
Hemocompatibility
Assessment of
Cardiovascular Materials.
2-268.................. Biological evaluation of ISO/TS 21726 First
medical devices-- edition 2019-02.
Application of the
threshold of
toxicological concern
(TTC) for assessing
biocompatibility of
medical device
constituents.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-259.................. Dentistry--Implants--Dyna ISO 14801 Third
mic loading test for edition
endosseous dental 2016-11-01.
implants.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-35.................. Standard for Standby UL 1989 Edition 5,
Batteries. 2013-10-02, ANSI
November 2018.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-422.................. Medical device safety AAMI TIR38:2019.
assurance case guidance.
6-423.................. CONSOLIDATED VERSION IEC 60601-2-6
Medical electrical Edition 2.1 2016-
equipment--Part 2-6: 04.
Particular requirements
for the basic safety and
essential performance of
microwave therapy
equipment.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-290.................. Establishing and CLSI EP34 1st
Verifying an Extended Edition.
Measuring Interval
Through Specimen
Dilution and Spiking.
7-291.................. How to Construct and CLSI EP27-A Vol. 32
Interpret an Error Grid No. 12, Replaces
for Quantitative EP27-P Vol. 29 No.
Diagnostic Assays; 16.
Approved Guideline.
7-292.................. Performance Standards for CLSI M62 1st
Susceptibility Testing Edition.
of Mycobacteria,
Nocardia spp., and other
Aerobic Actinomycetes.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-509.................. Standard Specification ASTM F702--18.
for Polysulfone Resin
for Medical Applications.
8-510.................. Standard Specification ASTM F997--18.
for Polycarbonate Resin
for Medical Applications.
8-511.................. Standard Specification ASTM F1925--17.
for Semi-Crystalline
Poly(lactide) Polymer
and Copolymer Resins for
Surgical Implants.
8-512.................. Standard Specification ASTM F2026--17.
for Polyetheretherketone
(PEEK) Polymers for
Surgical Implant
Applications.
8-513.................. Implants for surgery-- ISO 20160 First
Metallic materials-- edition 2006-05-01.
Classification of
microstructures for
alpha+beta titanium
alloy bars.
8-514.................. Implants for surgery-- ISO 5834-2 Fifth
Ultra-high-molecular- edition 2019-02.
weight polyethylene--
Part 2: Moulded forms.
8-515.................. Implants for surgery-- ISO 13779-3 Second
Hydroxyapatite--Part 3: edition 2018-12.
Chemical analysis and
characterization of
crystallinity ratio and
phase purity.
8-516.................. Implants for surgery-- ISO 13779-4 Second
Hydroxyapatite--Part 4: edition 2018-12.
Determination of coating
adhesion strength.
8-517.................. Non-active surgical ISO 17327-1 First
implants--Implant edition 2018-02.
coating--Part 1: General
requirements.
8-518.................. Standard Test Method for ASTM F3306--19.
Ion Release Evaluation
of Medical Implants.
------------------------------------------------------------------------
[[Page 57040]]
J. Nanotechnology
------------------------------------------------------------------------
18-13.................. Nanotechnologies--Electro ISO/TS 18827 First
n spin resonance (ESR) edition 2017-06.
as a method for
measuring reactive
oxygen species (ROS)
generated by metal oxide
nanomaterials.
18-14.................. Nanotechnologies--Methodo ISO/TR 11360 First
logy for the edition 2010-07-15.
classification and
categorization of
nanomaterials.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
10-116................. American National ANSI Z80.35-2018.
Standard for
Ophthalmics--Extended
Depth of Focus
Intraocular Lenses.
10-117................. American National ANSI Z80.37-2017.
Standard for
Ophthalmics--Slit-Lamp
Microscopes.
10-118................. American National ANSI Z80.38-2017.
Standard for
Ophthalmics--Light
Hazard from Operation
Microscopes Used in
Ocular Surgery.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-353................. Implants for surgery-- ISO 18192-3 First
Wear of total edition 2017-06.
intervertebral spinal
disc prostheses --Part
3: Impingement-wear
testing and
corresponding
environmental conditions
for test of lumbar
prostheses under adverse
kinematic conditions.
11-354................. Standard Guide for ASTM F3295--18.
Impingement Testing of
Total Disc Prostheses.
11-355................. Implants for surgery-- ISO 15142-1 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 1:
Intramedullary nails.
11-356................. Implants for surgery-- ISO 15142-2 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 2:
Locking components.
11-357................. Implants for surgery-- ISO 15142-3 First
Metal intramedullary edition 2003-08-01.
nailing systems--Part 3:
Connection devices and
reamer diameter
instruments.
11-358................. Implants for surgery-- ISO 14242-4 First
Wear of total hip-joint edition 2018-05.
prostheses--Part 4:
Testing hip prostheses
under variations in
component positioning
which results in direct
edge loading.
11-359................. Implants for surgery-- ISO 7206-10 Second
Partial and total hip- edition 2018-08.
joint prostheses--Part
10: Determination of
resistance to static
load of modular femoral
heads.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
16-206................. Wheelchairs--Part 30: ISO 7176-30 First
Wheelchairs for changing edition 2018-12.
occupant posture--Test
methods and requirements.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this
time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-108................. Health informatics--Point- IEEE Std 11073-20701-
of-care medical device 2018.
communication--Part
20701: Service-Oriented
Medical Device Exchange
Architecture and
Protocol Binding.
13-109................. (American National ANSI/AAMI/UL 2800-1:
Standard) Standard for 2019.
Safety for Medical
Device Interoperability.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-532................. Standard Test Method for ASTM F3287--17e1.
Nondestructive Detection
of Leaks in Packages by
Mass Extraction Method.
14-533................. Guidance on aspects of a ISO/TS 19930 First
risk-based approach to edition 2017-12.
assuring sterility of
terminally sterilized,
single-use health care
product that is unable
to withstand processing
to achieve maximally a
sterility assurance
level of 10-6.
------------------------------------------------------------------------
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 57041]]
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 following information available at
https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/recognition-standard.
Dated: October 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23198 Filed 10-23-19; 8:45 am]
BILLING CODE 4164-01-P