Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 054, 12476-12482 [2021-04376]
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
NDA holder not to avail itself of the
opportunity for a hearing concerning
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This notice is issued under section
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Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 2021–04344 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
054
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
SUMMARY:
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17:29 Mar 02, 2021
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modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 054’’
(Recognition List Number: 054), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
March 3, 2021.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: 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.’’
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Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 054.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500. FDA will
consider any comments received in
determining whether to amend the
current listing of modifications to the
list of recognized standards, Recognition
List Number: 054.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
An electronic copy of Recognition List
Number: 054 is available on the internet
at https://www.fda.gov/MedicalDevices/
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DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
IV for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 054
modifications and other standards
related information. Submit written
requests for a single hard copy of the
document entitled ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 054’’ to Scott
Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring,
MD 20993, 301–796–6287. Send one
self-addressed adhesive label to assist
that office in processing your request, or
fax your request to 301–847–8144.
FOR FURTHER INFORMATION CONTACT:
Scott Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring,
MD 20993, 301–796–6287,
CDRHStandardsStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
514 of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360d). Amended section 514 allows
FDA to recognize consensus standards
developed by international and national
organizations for use in satisfying
portions of device premarket review
submissions or other requirements.
In the Federal Register of September
14, 2018 (83 FR 46738), FDA announced
the availability of a guidance entitled
‘‘Appropriate Use of Voluntary
Consensus Standards in Premarket
Submissions for Medical Devices.’’ The
guidance describes how FDA has
implemented its standards recognition
program and is available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
appropriate-use-voluntary-consensusstandards-premarket-submissionsmedical-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-andconformity-assessment-program/federalregister-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-assessmentprogram/federal-register-documents.
Additional information on the Agency’s
Standards and Conformity Assessment
Program is available at https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 054
FDA is announcing the addition,
withdrawal, correction, and revision of
certain consensus standards the Agency
is recognizing for use in premarket
submissions and other requirements for
devices. FDA is incorporating these
modifications to the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database. FDA is
using the term ‘‘Recognition List
Number: 054’’ to identify the current
modifications.
In table 1, FDA describes the
following modifications: (1) The
withdrawal of standards and their
replacement by others, if applicable; (2)
the correction of errors made by FDA in
listing previously recognized standards;
and (3) the changes to the
supplementary information sheets of
recognized standards that describe
revisions to the applicability of the
standards.
In section III, FDA lists modifications
the Agency is making that involve new
entries and consensus standards added
as modifications to the list of recognized
standards under Recognition List
Number: 054.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Anesthesiology
1–98 .......................
1–146
ISO 80601–2–12 Second edition 2020–02 Medical electrical equipment—Part 2–12: Particular requirements for basic safety and essential performance of critical care ventilators.
Withdrawn and
newer version.
replaced
with
B. Biocompatibility
2–168 .....................
2–273
2–197 .....................
2–274
2–238 .....................
........................
ISO 10993–9 Third edition 2019–11 Biological evaluation of medical
devices—Part 9: Framework for identification and quantification of
potential degradation products.
ASTM F749—20 Standard Practice for Evaluating Material Extracts
by Intracutaneous Injection in the Rabbit.
ANSI/AAMI BE83:2006/(R)2011 Biological evaluation of medical devices—Part 18: Chemical characterization of materials.
Withdrawn and replaced with
newer version. Extent of recognition.
Withdrawn and replaced with
newer version.
Withdrawn.
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C. Cardiovascular
3–55 .......................
3–164
3–56 .......................
3–165
3–127 .....................
3–155
3–142 .....................
8–525
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ASTM F1830—19 Standard Practice for Collection and Preparation
of Blood for Dynamic In Vitro Evaluation of Blood Pumps.
ASTM 1841—19 Standard Practice for Assessment of Hemolysis in
Continuous Flow Blood Pumps.
ANSI/AAMI/IEC 60601–2–47:2012/(R)2016 Medical electrical equipment—Part 2–47: Particular requirements for the basic safety and
essential performance of ambulatory electrocardiographic systems.
ISO/TS 17137 Second edition 2019–09 Cardiovascular implants and
extracorporeal systems—Cardiovascular absorbable implants.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
3–152 .....................
3–123
3–160 .....................
3–166
Title of standard 1
Change
IEC 80601–2–30: Edition 2.0 2018–03 Medical electrical equipment
Part 2–30: Particular requirements for basic safety and essential
performance of automated type non-invasive sphygmomanometers.
ISO 81060–2 Third edition 2018–11 Non-invasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated
measurement type [Including AMENDMENT1 (2020)].
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and replaced
newer version.
Withdrawn and replaced
newer version.
Withdrawn and replaced
newer version.
Extent of recognition.
with
Withdrawn and
newer version.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
D. Dental/Ear, Nose, and Throat (ENT)
4–201 .....................
4–263
ISO 9693 Third edition 2019–10 Dentistry—Compatibility testing for
metal-ceramic and ceramic-ceramic systems.
E. General I (Quality Systems/Risk Management) (QS/RM)
5–110 .....................
5–126
5–111 .....................
5–127
5–112 .....................
5–128
5–114 .....................
5–129
5–116 .....................
5–130
ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less.
ISTA 3B 2017 Packaged-Products for Less-Than-Truckload (LTL)
Shipment.
ISTA 3E 2017 Similar Packaged-Products in Unitized Loads of
Truckload Shipment.
IEC 62366–1 Edition 1.1 2020–06 CONSOLIDATED VERSION
Medical devices—Part 1: Application of usability engineering to
medical devices.
ISO 7010 Third edition 2019–07 Graphical symbols—Safety colours
and safety signs—Registered safety signs.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–68 .......................
6–439
6–145 .....................
6–440
6–148 .....................
6–441
6–165 .....................
6–442
6–168 .....................
6–443
6–176 .....................
6–444
6–178 .....................
........................
6–183 .....................
6–445
6–244 .....................
6–446
6–318 .....................
6–447
ISO 7886–2 Second edition 2020–04 Sterile hypodermic syringes
for single use—Part 2: Syringes for use with power-driven syringe
pumps.
ASTM D3578—19 Standard Specification for Rubber Examination
Gloves.
ISO 7886–3 Second edition 2020–05 Sterile hypodermic syringes
for single use—Part 3: Auto-disabled syringes for fixed-dose immunization.
ASTM D6977—19 Standard Specification for Polychloroprene Examination Gloves for Medical Application.
ASTM D3577—19 Standard Specification for Rubber Surgical
Gloves.
ASTM D7103—19 Standard Guide for Assessment of Medical
Gloves.
ASTM D6124—06 (Reapproved 2017) Standard Test Method for
Residual Powder on Medical Gloves.
ASTM D5250—19 Standard Specification for Poly(vinyl chloride)
Gloves for Medical Application.
ASTM D6319—19 Standard Specification for Nitrile Examination
Gloves for Medical Application.
ISO 8536–4 Sixth edition 2019–09 Infusion equipment for medical
use—Part 4: Infusion sets for single use, gravity feed.
with
with
H. In Vitro Diagnostics (IVD)
No new entries at this time.
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I. Materials
8–227 .....................
8–526
8–343 .....................
8–527
8–349 .....................
8–528
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ASTM F2182—19e2 Standard Test Method for Measurement of
Radio Frequency Induced Heating On or Near Passive Implants
During Magnetic Resonance Imaging.
ASTM F899—20 Standard Specification for Wrought Stainless
Steels for Surgical Instruments.
ASTM F2503—20 Standard Practice for Marking Medical Devices
and Other Items for Safety in the Magnetic Resonance Environment.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
8–374 .....................
8–529
8–461 .....................
8–530
Title of standard 1
Change
ASTM F2633—19 Standard Specification for Wrought Seamless
Nickel-Titanium Shape Memory Alloy Tube for Medical Devices
and Surgical Implants.
ASTM F3208—19 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
with
Withdrawn and
newer version.
replaced
with
replaced
with
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11–215 ...................
11–363
11–222 ...................
11–364
11–253 ...................
11–365
11–275 ...................
11–366
11–292 ...................
11–367
ASTM F897—19 Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws.
ISO 14243–1 Second edition 2009–11–15 Implants for surgery—
Wear of total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control
and corresponding environmental conditions for test [Including
AMENDMENT1 (2020)].
ASTM F1800—19e1 Standard Practice for Cyclic Fatigue Testing of
Metal Tibial Tray Components of Total Knee Joint Replacements.
ASTM F2381—19 Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene
Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy.
ISO 14243–3 Second edition 2014–11–01 Implants for surgery—
Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
[Including AMENDMENT 1 (2020)].
O. Physical Medicine
16–170 ...................
........................
ANSI RESNA WC–1:2009 Section 3 American National Standard for
Wheelchairs—Volume 1: Additional Requirements for Wheelchairs
(including Scooters) Section 3: Determination of effectiveness of
brakes.
Title change.
P. Radiology
12–287 ...................
12–330
12–325 ...................
........................
NEMA Standards Publication XR 28–2018 Supplemental Requirements for User Information and System Function Related to Dose
in CT.
NEMA Standards Publication XR 25–2019 Computed Tomography
Dose Check.
Withdrawn and
newer version.
Transition period extended.
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Q. Software/Informatics
13–80 .....................
13–113
13–110 ...................
13–114
IEEE Std 11073–20601–2019 Health informatics—Personal health
device communication—Part 20601: Application profile—Optimized exchange protocol.
IEEE Std 11073–10101–2019 Health informatics—Point-of-care
medical device communication—Part 10101: Nomenclature.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
R. Sterility
14–313 ...................
VerDate Sep<11>2014
14–539
17:29 Mar 02, 2021
ASTM F2475—20 Standard Guide for Biocompatibility Evaluation of
Medical Device Packaging Materials.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
14–327 ...................
14–540
14–360 ...................
14–541
14–408 ...................
2–275
14–436 ...................
14–542
14–515 ...................
........................
14–528 ...................
14–543
14–529 ...................
14–544
14–530 ...................
14–545
14–531 ...................
14–546
14–532 ...................
14–533 ...................
14–547
14–548
Title of standard 1
Change
ISO 11737–2 Third edition 2019–12 Sterilization of health care products—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
ANSI/AAMI ST72:2019 Bacterial endotoxins—Test methods, routine
monitoring, and alternatives to batch testing.
ISO 10993–7 Second edition 2008–10–15 Biological evaluation of
medical devices—Part 7: Ethylene oxide sterilization residuals [Including Corrigendum 1 (2009) and AMENDMENT 1 (2020)].
ISO/ASTM 52628 Second edition 2020–04 Standard practice for dosimetry in radiation processing.
ISO 17664 Second edition 2017–10 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 11139 First edition 2018–08 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards.
ISO 18472 Second edition 2018–08 Sterilization of health care products—Biological and chemical indicators—Test equipment.
ISO/ASTM 51276 Fourth edition 2019–08 Practice for use of a
polymethylmethacrylate dosimetry system.
USP 42–NF37:2019 <61> Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests.
USP 42–NF37:2019 <71> Sterility Tests ............................................
USP 42–NF37:2019 <85> Bacterial Endotoxins Test .........................
Withdrawn and
newer version.
replaced
with
Withdrawn and replaced with
newer version.
Withdrawn and replaced with
newer version. Transferred.
Withdrawn and replaced
newer version.
Extent of recognition.
with
New recognition number.
New recognition number.
New recognition number.
New recognition number.
New recognition number.
New recognition number.
S. Tissue Engineering
15–19 .....................
15–59
15–30 .....................
15–60
15–39 .....................
15–61
15–41 .....................
15–62
15–50 .....................
15–63
1 All
ASTM F2450—18 Standard Guide for Assessing Microstructure of
Polymeric Scaffolds for Use in Tissue-Engineered Medical Products.
ASTM F2212—19 Standard Guide for Characterization of Type I
Collagen as Starting Material for Surgical Implants and Substrates
for Tissue Engineered Medical Products (TEMPs).
ASTM F2150 19 Standard Guide for Characterization and Testing of
Biomaterial Scaffolds Used in Regenerative Medicine and TissueEngineered Medical Products.
ASTM F2602—18 Standard Test Method for Determining the Molar
Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).
ASTM F2739—19 Standard Guide for Quantifying Cell Viability and
Related Attributes within Biomaterial Scaffolds.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
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newer version.
replaced
with
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newer version.
replaced
with
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newer version.
replaced
with
standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In Table 2, FDA provides the listing
of new entries and consensus standards
added as modifications to the list of
recognized standards under Recognition
List Number: 054. These entries are of
standards not previously recognized by
FDA.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. Anesthesiology
No new entries at this time.
B. Biocompatibility
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2–276 ..................
Biological evaluation of medical devices—Part 18: Chemical characterization of
medical device materials within a risk management process.
ISO 10993–18 Second edition 2020–01.
C. Cardiovascular
3–167 ..................
VerDate Sep<11>2014
Non-invasive sphygmomanometers—Part 5: Requirements for the repeatability
and reproducibility of NIBP simulators for testing of automated non-invasive
sphygmomanometers.
17:29 Mar 02, 2021
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ISO/TS 81060–5 First edition 2020–02.
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12481
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition No.
Title of standard 1
3–168 ..................
Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including
Amendment 1 (2019)].
Reference No. and date
IEEE Std 1708–2014.
D. Dental/Ear, Nose, and Throat (ENT)
No new entries at this time.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
No new entries at this time.
H. In Vitro Diagnostics (IVD)
7–296 ..................
7–297 ..................
7–298 ..................
Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
Medical laboratories—Practical guidance for the estimation of measurement uncertainty.
Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures.
CLSI EP09c 3rd Edition.
ISO/TS 20914 First edition 2019–07.
CLSI EP35 1st Edition.
I. Materials
8–531 ..................
8–532 ..................
8–533 ..................
8–534 ..................
8–535 ..................
8–536 ..................
Standard Guide for Methods of Extraction of Test Soils for the Validation of
Cleaning Methods for Reusable Medical Devices.
Standard Guide for Assessing the Removal of Additive Manufacturing Residues
in Medical Devices Fabricated by Powder Bed Fusion.
Additive Manufacturing—Feedstock materials—Methods to characterize metal
powders.
Additive Manufacturing—Design—Part 1: Laser-based powder bed fusion of metals.
Additive Manufacturing—Design—Part 2: Laser-based powder bed fusion of polymers.
Additive Manufacturing—Test Artifacts—Geometric capability assessment of additive manufacturing systems.
ASTM F3321—19.
ASTM F3335—20.
ISO/ASTM
11.
ISO/ASTM
07.
ISO/ASTM
09.
ISO/ASTM
07.
52907: First Edition 2019–
52911–1: First Edition 2019–
52911–2: First Edition 2019–
52902: First Edition 2019–
J. Nanotechnology
18–15 ..................
18–16 ..................
Standard Guide for Tiered Approach to Detection and Characterization of Silver
Nanomaterials in Textiles..
Nanotechnologies—Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow fractionation.
ASTM E3025—16.
ISO/TS 21362 First edition 2018–06.
K. Neurology
No new entries at this time.
jbell on DSKJLSW7X2PROD with NOTICES
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–124 ..................
9–125 ..................
Colorimetry—Part 1: CIE standard colorimetric observers ......................................
Colorimetry—Part 2: CIE standard illuminants ........................................................
9–126 ..................
9–127 ..................
9–128 ..................
Colorimetry—Part 3: CIE tristimulus values .............................................................
Colorimetry—Part 4: CIE 1976 L*a*b* colour space ...............................................
Colorimetry—Part 6: CIEDE2000 colour-difference formula ....................................
9–129 ..................
Multimedia systems and equipment—Colour measurement and management—
Part 2–1: Colour management—Default RGB colour space—sRGB [Including
Amendment 1 (2003) and Corrigendum 1 (2014)].
VerDate Sep<11>2014
17:29 Mar 02, 2021
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ISO/CIE 11664–1 First edition 2019–06.
ISO 11664–2 CIE S 014–2/E First edition 2007–10–15 Corrected version
2008–11–01.
ISO/CIE 11664–3 First edition 2019–06.
ISO/CIE 11664–4 First edition 2019–06.
ISO/CIE 11664–6 First edition 2014–02–
01.
IEC 61966–2–1 First edition 1999–10.
03MRN1
12482
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11–368 ................
11–369 ................
Standard Practice for Finite Element Analysis (FEA) of Metallic Orthopaedic Total
Knee Tibial Components.
Standard Practice for Inspection of Spinal Implants Undergoing Testing ...............
ASTM F3334—19.
ASTM F3292—19.
O. Physical Medicine
No new entries at this time.
P. Radiology
12–331 ................
12–332 ................
12–333 ................
12–334 ................
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance
Imaging Systems.
Magnetic resonance equipment for medical imaging—Part 1: Determination of
essential image quality parameters.
Guidance on error and warning messages for software used in radiotherapy .......
Radiation therapy machine characterization ............................................................
NEMA Standards Publication MS 14–
2019.
IEC 62464–1 Edition 2.0 2018–12.
IEC TR 63183 Edition 1.0 2019–12.
AAMI RT3:2020.
Q. Software/Informatics
13–115 ................
Software and systems engineering—Software testing—Part 1: Concepts and definitions.
ISO/IEC/IEEE 29119–1
2013–09–01.
First
edition
R. Sterility
14–549 ................
Standard Test Method for Evaluation of Seal Quality and Integrity Using Airborne
Ultrasound.
ASTM F3004—13e1.
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.
jbell on DSKJLSW7X2PROD with NOTICES
V. Recommendation of Standards for
Recognition by FDA
17:29 Mar 02, 2021
Jkt 253001
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04376 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1638]
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
VerDate Sep<11>2014
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/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Lawrence B. Ryan: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00073
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) permanently debarring Lawrence B.
Ryan from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Ryan was convicted of
a felony under Federal law for conduct
that relates to the regulation of a drug
product under the FD&C Act. Mr. Ryan
was given notice of the proposed
permanent debarment and an
opportunity to request a hearing to show
why he should not be debarred. As of
October 18, 2020 (30 days after receipt
of the notice), Mr. Ryan had not
responded. Mr. Ryan’s failure to
respond and request a hearing
constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is applicable March 3,
2021.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
SUMMARY:
E:\FR\FM\03MRN1.SGM
03MRN1
]]>Agencies
[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12476-12482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 054
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a publication containing modifications the Agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
Recognized Consensus Standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 054'' (Recognition List Number: 054), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable March 3, 2021.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: 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: 054.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
FDA will consider any comments received in determining whether to amend
the current listing of modifications to the list of recognized
standards, Recognition List Number: 054.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
An electronic copy of Recognition List Number: 054 is available on
the internet at https://www.fda.gov/MedicalDevices/
[[Page 12477]]
DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for
electronic access to the searchable database for the current list of
FDA recognized consensus standards, including Recognition List Number:
054 modifications and other standards related information. Submit
written requests for a single hard copy of the document entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 054'' to Scott Colburn, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-847-8144.
FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5606, Silver Spring, MD 20993, 301-796-6287,
[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 on its
website hypertext markup language (HTML) and portable document format
(PDF) versions of the list of FDA Recognized Consensus Standards,
available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. Additional
information on the Agency's Standards and Conformity Assessment Program
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 054
FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency is recognizing for
use in premarket submissions and other requirements for devices. FDA is
incorporating these modifications to the list of FDA Recognized
Consensus Standards in the Agency's searchable database. FDA is using
the term ``Recognition List Number: 054'' to identify the current
modifications.
In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III, FDA lists modifications the Agency is making that
involve new entries and consensus standards added as modifications to
the list of recognized standards under Recognition List Number: 054.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-98............................... 1-146 ISO 80601-2-12 Second edition Withdrawn and replaced
2020-02 Medical electrical with newer version.
equipment--Part 2-12:
Particular requirements for
basic safety and essential
performance of critical care
ventilators.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-168.............................. 2-273 ISO 10993-9 Third edition 2019- Withdrawn and replaced
11 Biological evaluation of with newer version.
medical devices--Part 9: Extent of recognition.
Framework for identification
and quantification of
potential degradation products.
2-197.............................. 2-274 ASTM F749--20 Standard Practice Withdrawn and replaced
for Evaluating Material with newer version.
Extracts by Intracutaneous
Injection in the Rabbit.
2-238.............................. .............. ANSI/AAMI BE83:2006/(R)2011 Withdrawn.
Biological evaluation of
medical devices--Part 18:
Chemical characterization of
materials.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-55............................... 3-164 ASTM F1830--19 Standard Withdrawn and replaced
Practice for Collection and with newer version.
Preparation of Blood for
Dynamic In Vitro Evaluation of
Blood Pumps.
3-56............................... 3-165 ASTM 1841--19 Standard Practice Withdrawn and replaced
for Assessment of Hemolysis in with newer version.
Continuous Flow Blood Pumps.
3-127.............................. 3-155 ANSI/AAMI/IEC 60601-2-47:2012/ Transferred.
(R)2016 Medical electrical
equipment--Part 2-47:
Particular requirements for
the basic safety and essential
performance of ambulatory
electrocardiographic systems.
3-142.............................. 8-525 ISO/TS 17137 Second edition Withdrawn and replaced
2019-09 Cardiovascular with newer version.
implants and extracorporeal Transferred.
systems--Cardiovascular
absorbable implants.
[[Page 12478]]
3-152.............................. 3-123 IEC 80601-2-30: Edition 2.0 Withdrawn and replaced
2018-03 Medical electrical with newer version.
equipment Part 2-30:
Particular requirements for
basic safety and essential
performance of automated type
non-invasive sphygmomanometers.
3-160.............................. 3-166 ISO 81060-2 Third edition 2018- Withdrawn and replaced
11 Non-invasive with newer version.
sphygmomanometers--Part 2:
Clinical investigation of
intermittent automated
measurement type [Including
AMENDMENT1 (2020)].
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-201.............................. 4-263 ISO 9693 Third edition 2019-10 Withdrawn and replaced
Dentistry--Compatibility with newer version.
testing for metal-ceramic and
ceramic-ceramic systems.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-110.............................. 5-126 ISTA 3A 2018 Packaged-Products Withdrawn and replaced
for Parcel Delivery System with newer version.
Shipment 70 kg (150 lb) or
Less.
5-111.............................. 5-127 ISTA 3B 2017 Packaged-Products Withdrawn and replaced
for Less-Than-Truckload (LTL) with newer version.
Shipment.
5-112.............................. 5-128 ISTA 3E 2017 Similar Packaged- Withdrawn and replaced
Products in Unitized Loads of with newer version.
Truckload Shipment.
5-114.............................. 5-129 IEC 62366-1 Edition 1.1 2020-06 Withdrawn and replaced
CONSOLIDATED VERSION Medical with newer version.
devices--Part 1: Application
of usability engineering to
medical devices.
5-116.............................. 5-130 ISO 7010 Third edition 2019-07 Withdrawn and replaced
Graphical symbols--Safety with newer version.
colours and safety signs--
Registered safety signs.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-68............................... 6-439 ISO 7886-2 Second edition 2020- Withdrawn and replaced
04 Sterile hypodermic syringes with newer version.
for single use--Part 2:
Syringes for use with power-
driven syringe pumps.
6-145.............................. 6-440 ASTM D3578--19 Standard Withdrawn and replaced
Specification for Rubber with newer version.
Examination Gloves.
6-148.............................. 6-441 ISO 7886-3 Second edition 2020- Withdrawn and replaced
05 Sterile hypodermic syringes with newer version.
for single use--Part 3: Auto-
disabled syringes for fixed-
dose immunization.
6-165.............................. 6-442 ASTM D6977--19 Standard Withdrawn and replaced
Specification for with newer version.
Polychloroprene Examination
Gloves for Medical Application.
6-168.............................. 6-443 ASTM D3577--19 Standard Withdrawn and replaced
Specification for Rubber with newer version.
Surgical Gloves.
6-176.............................. 6-444 ASTM D7103--19 Standard Guide Withdrawn and replaced
for Assessment of Medical with newer version.
Gloves.
6-178.............................. .............. ASTM D6124--06 (Reapproved Extent of recognition.
2017) Standard Test Method for
Residual Powder on Medical
Gloves.
6-183.............................. 6-445 ASTM D5250--19 Standard Withdrawn and replaced
Specification for Poly(vinyl with newer version.
chloride) Gloves for Medical
Application.
6-244.............................. 6-446 ASTM D6319--19 Standard Withdrawn and replaced
Specification for Nitrile with newer version.
Examination Gloves for Medical
Application.
6-318.............................. 6-447 ISO 8536-4 Sixth edition 2019- Withdrawn and replaced
09 Infusion equipment for with newer version.
medical use--Part 4: Infusion
sets for single use, gravity
feed.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-227.............................. 8-526 ASTM F2182--19[epsi]2 Standard Withdrawn and replaced
Test Method for Measurement of with newer version.
Radio Frequency Induced
Heating On or Near Passive
Implants During Magnetic
Resonance Imaging.
8-343.............................. 8-527 ASTM F899--20 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Stainless Steels for Surgical
Instruments.
8-349.............................. 8-528 ASTM F2503--20 Standard Withdrawn and replaced
Practice for Marking Medical with newer version.
Devices and Other Items for
Safety in the Magnetic
Resonance Environment.
[[Page 12479]]
8-374.............................. 8-529 ASTM F2633--19 Standard Withdrawn and replaced
Specification for Wrought with newer version.
Seamless Nickel-Titanium Shape
Memory Alloy Tube for Medical
Devices and Surgical Implants.
8-461.............................. 8-530 ASTM F3208--19 Standard Guide Withdrawn and replaced
for Selecting Test Soils for with newer version.
Validation of Cleaning Methods
for Reusable Medical Devices.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-215............................. 11-363 ASTM F897--19 Standard Test Withdrawn and replaced
Method for Measuring Fretting with newer version.
Corrosion of Osteosynthesis
Plates and Screws.
11-222............................. 11-364 ISO 14243-1 Second edition 2009- Withdrawn and replaced
11-15 Implants for surgery-- with newer version.
Wear of total knee-joint
prostheses--Part 1: Loading
and displacement parameters
for wear-testing machines with
load control and corresponding
environmental conditions for
test [Including AMENDMENT1
(2020)].
11-253............................. 11-365 ASTM F1800--19[epsi]1 Standard Withdrawn and replaced
Practice for Cyclic Fatigue with newer version.
Testing of Metal Tibial Tray
Components of Total Knee Joint
Replacements.
11-275............................. 11-366 ASTM F2381--19 Standard Test Withdrawn and replaced
Method for Evaluating Trans- with newer version.
Vinylene Yield in Irradiated
Ultra-High Molecular Weight
Polyethylene Fabricated Forms
Intended for Surgical Implants
by Infrared Spectroscopy.
11-292............................. 11-367 ISO 14243-3 Second edition 2014- Withdrawn and replaced
11-01 Implants for surgery-- with newer version.
Wear of total knee-joint
prostheses--Part 3: Loading
and displacement parameters
for wear-testing machines with
displacement control and
corresponding environmental
conditions for test [Including
AMENDMENT 1 (2020)].
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-170............................. .............. ANSI RESNA WC-1:2009 Section 3 Title change.
American National Standard for
Wheelchairs--Volume 1:
Additional Requirements for
Wheelchairs (including
Scooters) Section 3:
Determination of effectiveness
of brakes.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-287............................. 12-330 NEMA Standards Publication XR Withdrawn and replaced
28-2018 Supplemental with newer version.
Requirements for User
Information and System
Function Related to Dose in CT.
12-325............................. .............. NEMA Standards Publication XR Transition period
25-2019 Computed Tomography extended.
Dose Check.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-80.............................. 13-113 IEEE Std 11073-20601-2019 Withdrawn and replaced
Health informatics--Personal with newer version.
health device communication--
Part 20601: Application
profile--Optimized exchange
protocol.
13-110............................. 13-114 IEEE Std 11073-10101-2019 Withdrawn and replaced
Health informatics--Point-of- with newer version.
care medical device
communication--Part 10101:
Nomenclature.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-313............................. 14-539 ASTM F2475--20 Standard Guide Withdrawn and replaced
for Biocompatibility with newer version.
Evaluation of Medical Device
Packaging Materials.
[[Page 12480]]
14-327............................. 14-540 ISO 11737-2 Third edition 2019- Withdrawn and replaced
12 Sterilization of health with newer version.
care products--Microbiological
methods--Part 2: Tests of
sterility performed in the
definition, validation and
maintenance of a sterilization
process.
14-360............................. 14-541 ANSI/AAMI ST72:2019 Bacterial Withdrawn and replaced
endotoxins--Test methods, with newer version.
routine monitoring, and
alternatives to batch testing.
14-408............................. 2-275 ISO 10993-7 Second edition 2008- Withdrawn and replaced
10-15 Biological evaluation of with newer version.
medical devices--Part 7: Transferred.
Ethylene oxide sterilization
residuals [Including
Corrigendum 1 (2009) and
AMENDMENT 1 (2020)].
14-436............................. 14-542 ISO/ASTM 52628 Second edition Withdrawn and replaced
2020-04 Standard practice for with newer version.
dosimetry in radiation
processing.
14-515............................. .............. ISO 17664 Second edition 2017- Extent of recognition.
10 Processing of health care
products--Information to be
provided by the medical device
manufacturer for the
processing of medical devices.
14-528............................. 14-543 ISO 11139 First edition 2018-08 New recognition number.
Sterilization of health care
products--Vocabulary of terms
used in sterilization and
related equipment and process
standards.
14-529............................. 14-544 ISO 18472 Second edition 2018- New recognition number.
08 Sterilization of health
care products--Biological and
chemical indicators--Test
equipment.
14-530............................. 14-545 ISO/ASTM 51276 Fourth edition New recognition number.
2019-08 Practice for use of a
polymethylmethacrylate
dosimetry system.
14-531............................. 14-546 USP 42-NF37:2019 <61> New recognition number.
Microbiological Examination of
Nonsterile Products: Microbial
Enumeration Tests.
14-532............................. 14-547 USP 42-NF37:2019 <71> Sterility New recognition number.
Tests.
14-533............................. 14-548 USP 42-NF37:2019 <85> Bacterial New recognition number.
Endotoxins Test.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-19.............................. 15-59 ASTM F2450--18 Standard Guide Withdrawn and replaced
for Assessing Microstructure with newer version.
of Polymeric Scaffolds for Use
in Tissue-Engineered Medical
Products.
15-30.............................. 15-60 ASTM F2212--19 Standard Guide Withdrawn and replaced
for Characterization of Type I with newer version.
Collagen as Starting Material
for Surgical Implants and
Substrates for Tissue
Engineered Medical Products
(TEMPs).
15-39.............................. 15-61 ASTM F2150 19 Standard Guide Withdrawn and replaced
for Characterization and with newer version.
Testing of Biomaterial
Scaffolds Used in Regenerative
Medicine and Tissue-Engineered
Medical Products.
15-41.............................. 15-62 ASTM F2602--18 Standard Test Withdrawn and replaced
Method for Determining the with newer version.
Molar Mass of Chitosan and
Chitosan Salts by Size
Exclusion Chromatography with
Multi-angle Light Scattering
Detection (SEC-MALS).
15-50.............................. 15-63 ASTM F2739--19 Standard Guide Withdrawn and replaced
for Quantifying Cell Viability with newer version.
and Related Attributes within
Biomaterial Scaffolds.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
III. Listing of New Entries
In Table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 054. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Recognition No. Title of standard \1\ Reference No. and date
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-276......................... Biological evaluation of medical devices--Part ISO 10993-18 Second edition
18: Chemical characterization of medical device 2020-01.
materials within a risk management process.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-167......................... Non-invasive sphygmomanometers--Part 5: ISO/TS 81060-5 First edition
Requirements for the repeatability and 2020-02.
reproducibility of NIBP simulators for testing
of automated non-invasive sphygmomanometers.
[[Page 12481]]
3-168......................... Standard for Wearable, Cuffless Blood Pressure IEEE Std 1708-2014.
Measuring Devices [Including Amendment 1 (2019)].
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-296......................... Measurement Procedure Comparison and Bias CLSI EP09c 3rd Edition.
Estimation Using Patient Samples.
7-297......................... Medical laboratories--Practical guidance for the ISO/TS 20914 First edition
estimation of measurement uncertainty. 2019-07.
7-298......................... Assessment of Equivalence or Suitability of CLSI EP35 1st Edition.
Specimen Types for Medical Laboratory
Measurement Procedures.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-531......................... Standard Guide for Methods of Extraction of Test ASTM F3321--19.
Soils for the Validation of Cleaning Methods for
Reusable Medical Devices.
8-532......................... Standard Guide for Assessing the Removal of ASTM F3335--20.
Additive Manufacturing Residues in Medical
Devices Fabricated by Powder Bed Fusion.
8-533......................... Additive Manufacturing--Feedstock materials-- ISO/ASTM 52907: First Edition
Methods to characterize metal powders. 2019-11.
8-534......................... Additive Manufacturing--Design--Part 1: Laser- ISO/ASTM 52911-1: First
based powder bed fusion of metals. Edition 2019-07.
8-535......................... Additive Manufacturing--Design--Part 2: Laser- ISO/ASTM 52911-2: First
based powder bed fusion of polymers. Edition 2019-09.
8-536......................... Additive Manufacturing--Test Artifacts--Geometric ISO/ASTM 52902: First Edition
capability assessment of additive manufacturing 2019-07.
systems.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-15......................... Standard Guide for Tiered Approach to Detection ASTM E3025--16.
and Characterization of Silver Nanomaterials in
Textiles..
18-16......................... Nanotechnologies--Analysis of nano-objects using ISO/TS 21362 First edition
asymmetrical-flow and centrifugal field-flow 2018-06.
fractionation.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-124......................... Colorimetry--Part 1: CIE standard colorimetric ISO/CIE 11664-1 First edition
observers. 2019-06.
9-125......................... Colorimetry--Part 2: CIE standard illuminants.... ISO 11664-2 CIE S 014-2/E
First edition 2007-10-15
Corrected version 2008-11-
01.
9-126......................... Colorimetry--Part 3: CIE tristimulus values...... ISO/CIE 11664-3 First edition
2019-06.
9-127......................... Colorimetry--Part 4: CIE 1976 L*a*b* colour space ISO/CIE 11664-4 First edition
2019-06.
9-128......................... Colorimetry--Part 6: CIEDE2000 colour-difference ISO/CIE 11664-6 First edition
formula. 2014-02-01.
9-129......................... Multimedia systems and equipment--Colour IEC 61966-2-1 First edition
measurement and management--Part 2-1: Colour 1999-10.
management--Default RGB colour space--sRGB
[Including Amendment 1 (2003) and Corrigendum 1
(2014)].
----------------------------------------------------------------------------------------------------------------
[[Page 12482]]
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-368........................ Standard Practice for Finite Element Analysis ASTM F3334--19.
(FEA) of Metallic Orthopaedic Total Knee Tibial
Components.
11-369........................ Standard Practice for Inspection of Spinal ASTM F3292--19.
Implants Undergoing Testing.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-331........................ Characterization of Radiofrequency (RF) Coil NEMA Standards Publication MS
Heating in Magnetic Resonance Imaging Systems. 14-2019.
12-332........................ Magnetic resonance equipment for medical imaging-- IEC 62464-1 Edition 2.0 2018-
Part 1: Determination of essential image quality 12.
parameters.
12-333........................ Guidance on error and warning messages for IEC TR 63183 Edition 1.0 2019-
software used in radiotherapy. 12.
12-334........................ Radiation therapy machine characterization....... AAMI RT3:2020.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-115........................ Software and systems engineering--Software ISO/IEC/IEEE 29119-1 First
testing--Part 1: Concepts and definitions. edition 2013-09-01.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-549........................ Standard Test Method for Evaluation of Seal ASTM F3004--13[epsi]1.
Quality and Integrity Using Airborne Ultrasound.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[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/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04376 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P
