Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056, 70132-70139 [2021-26635]
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
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INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326,
Silver Spring, MD 20993–0002, 301–
796–3161, Dianne.Paraoan@
fda.hhs.gov; or Stephen Ripley, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911, Stephen.Ripley@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Considerations for the Use of RealWorld Data and Real-World Evidence to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ The
draft guidance discusses the following
major topics: (1) Applicability of part
312 (21 CFR part 312) to studies using
RWD and (2) regulatory considerations
for non-interventional (observational)
studies using RWD. Topics covered
under regulatory considerations include
the following: (1) Transparency for data
collection and analysis, (2) data access,
(3) study monitoring, (4) safety
reporting, and (5) sponsor
responsibilities.
Section 3022 of the 21st Century
Cures Act (Cures Act) amended the
FD&C Act to add section 505F, Utilizing
Real World Evidence (21 U.S.C. 355g).
This section requires the establishment
of a program to evaluate the potential
use of RWE to help support the approval
of a new indication for a drug approved
under section 505(c) of the FD&C Act
(21 U.S.C. 355(c)) and to help support
or satisfy postapproval study
requirements. This section also requires
that FDA utilize the program to inform
guidance for industry on the
circumstances under which sponsors of
drugs may rely on RWE and the
appropriate standards and
methodologies for collection and
analysis of RWE submitted to evaluate
the potential use of RWE for those
purposes. Further, under the
Prescription Drug User Fee
Amendments of 2017 (PDUFA VI), FDA
is committed to publishing draft
guidance on how RWE can contribute to
the assessment of safety and
effectiveness in regulatory submissions.
FDA is issuing the draft guidance
entitled ‘‘Considerations for the Use of
Real-World Data and Real-World
Evidence to Support Regulatory
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Decision-Making for Drug and
Biological Products’’ as part of a series
of guidance documents to satisfy the
Cures Act mandate and the PDUFA VI
commitment.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Considerations for the Use of RealWorld Data and Real-World Evidence to
Support Regulatory Decision-Making for
Drug and Biological Products.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 11 have been
approved under OMB control number
0910–0303. The collections of
information in 21 CFR parts 50 and 56
have been approved under OMB control
number 0910–0130. The collections of
information in 21 CFR part 54 have been
approved under OMB control number
0910–0396. The collections of
information in 21 CFR part 310 have
been approved under OMB control
number 0910–0230. The collections of
information in 21 CFR parts 310, 314,
and 600 have been approved under
OMB control number 0910–0645. The
collections of information in 21 CFR
parts 310, 314, and 600 have been
approved under OMB control number
0910–0291. The collections of
information in part 312 have been
approved under OMB control number
0910–0014. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001. The collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338. The collections of
information in 21 CFR part 600 have
been approved under OMB control
number 0910–0458. The collections of
information in FDA’s guidance for
industry entitled ‘‘Oversight of Clinical
Investigations: A Risk-Based Approach
to Monitoring’’ have been approved
under OMB control number 0910–0733.
The collections of information in FDA’s
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guidance for industry entitled ‘‘Formal
Meetings with Sponsors and Applicants
for PDUFA Products’’ have been
approved under OMB control number
0910–0429.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: December 2, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26640 Filed 12–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
056
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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: 056’’
(Recognition List Number: 056), 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
December 9, 2021.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
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• 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: 056.’’ 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: 056.
• 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
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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: 056 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 FDArecognized consensus standards,
including Recognition List Number: 056
modifications and other standardsrelated information. Submit written
requests for a single hard copy of the
document entitled ‘‘Modifications to the
List of Recognized Standards,
Recognition List Number: 056’’ 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
PO 00000
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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: 056
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
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Number: 056’’ 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
Old recognition No.
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.
Replacement
recognition
No.
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: 056.
Title of standard 1
Change
A. Anesthesiology
1–115 .....................
1–151
ISO 80601–2–70 Second edition 2020–11 Medical electrical equipment—Part 2–70: Particular requirements for the basic safety and
essential performance of sleep apnea breathing therapy equipment.
Withdrawn and
newer version.
replaced
with
Withdrawn and replaced
newer version.
Withdrawn. See 2–290.
with
Withdrawn and replaced
newer version.
Extent of recognition.
with
B. Biocompatibility
2–191 .....................
2–289
2–241 .....................
........................
ISO 10993–12 Fifth edition 2021–01 Biological evaluation of medical
devices—Part 12: Sample preparation and reference materials.
ISO/TR 37137 First edition 2014–05–15 Cardiovascular biological
evaluation of medical devices—Guidance for absorbable implants.
C. Cardiovascular
3–92 .......................
3–170
3–129 .....................
........................
3–166 .....................
........................
3–168 .....................
........................
ISO 14708–5 Second edition 2020–05 Implants for surgery—Active
implantable medical devices—Part 5: Circulatory support devices.
ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient
leadwires.
ISO 81060–2 Third edition 2018–11 Noninvasive sphygmomanometers—Part 2: Clinical investigation of intermittent automated
measurement type [Including: Amendment 1 (2020)].
IEEE Std 1708–2014 Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)].
Extent of recognition.
Extent of recognition.
D. Dental/Ear, Nose, and Throat (ENT)
4–105 .....................
........................
4–164 .....................
4–273
4–183 .....................
4–274
4–194 .....................
........................
4–195 .....................
........................
4–203 .....................
4–275
4–206 .....................
4–276
4–216 .....................
4–277
4–225 .....................
4–278
ANSI/ADA Standard No. 75—1997 (R2014) Resilient Lining Materials for Removable Dentures, Part 1: Short-Term Materials.
ANSI/ASA S3.7–2016 (Reaffirmed 2020) American National Standard Method for Measurement and Calibration of Earphones.
ANSI/ASA S3.2–2020 American National Standard Method for
Measuring the Intelligibility of Speech over Communication Systems.
ANSI/ADA Standard No. 78—2006 Dental obturating cones (Modified adoption of ISO 6877–1:1995, Dental obturating points).
ISO 14801 Second edition 2007–11–15 Dentistry—Implants—Dynamic fatigue test for endosseous dental implants.
ANSI/ASA S3.6–2018 American National Standard Specification for
Audiometers.
ISO 14457 Second edition 2017–10 Dentistry—Handpieces and motors.
ANSI/IEEE C63.19–2019 American National Standard Methods of
Measurement of Compatibility between Wireless Communication
Devices and Hearing Aids.
ISO 4823 Fifth edition 2021–02 Dentistry—Elastomeric impression
and bite registration materials.
Withdrawn.
Withdrawn and
newer version.
Withdrawn and
newer version.
replaced
with
replaced
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.
replaced
with
Withdrawn.
Withdrawn.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
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F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–23 .....................
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IEC 60086–4 Edition 5.0 2019–04 Primary batteries—Part 4: Safety
of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)].
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Old recognition No.
Replacement
recognition
No.
Title of standard 1
Change
G. General Hospital/General Plastic Surgery (GH/GPS)
6–385 .....................
6–461
6–386 .....................
6–462
6–388 .....................
6–463
6–389 .....................
........................
IEC 60601–2–19 Edition 3.0 2020–09 Medical electrical equipment—Part 2–19: Particular requirements for the basic safety and
essential performance of infant incubators.
IEC 60601–2–20 Edition 3.0 2020–09 Medical electrical equipment—Part 2–20: Particular requirements for the basic safety and
essential performance of infant transport incubators.
IEC 60601–2–21 Edition 3.0 2020–09 Medical electrical equipment—Part 2–21: Particular requirements for the basic safety and
essential performance of infant radiant warmers.
IEC 60601–2–2 Edition 6.0 2017–03 Medical electrical equipment—
Part 2–2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high
frequency surgical accessories.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Extent of recognition.
H. In Vitro Diagnostics (IVD)
7–193 .....................
7–306
7–209 .....................
7–307
7–236 .....................
........................
7–262 .....................
........................
7–292 .....................
........................
7–294 .....................
7–308
CLSI EP06 2nd Edition Evaluation of the Linearity of Quantitative
Measurement Procedures.
CLSI POCT05 2nd Edition Performance Metrics for Continuous Interstitial Glucose Monitoring.
CLSI M43–A October 2011 Methods for Antimicrobial Susceptibility
Testing for Human Mycoplasmas; Approved Guideline.
CLSI M45 3rd Edition Methods for Antimicrobial Dilution and Disk
Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria.
CLSI M62 1st Edition Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic
Actinomycetes.
CLSI M100 31st Edition Performance Standards for Antimicrobial
Susceptibility Testing.
Withdrawn and replaced
newer version.
Withdrawn and replaced
newer version.
Extent of recognition.
with
with
Extent of recognition.
Extent of recognition.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and replaced
newer version.
Withdrawn. See 8–561.
with
Withdrawn and replaced
newer version.
Withdrawn. See 8–562.
with
I. Materials
8–394 .....................
8–555
8–418 .....................
8–556
8–445 .....................
........................
8–486 .....................
8–557
8–490 .....................
........................
ASTM F1472–20a Standard Specification for Wrought Titanium6Aluminum-4Vanadium Alloy for Surgical Implant Applications
(UNS R56400).
ASTM F640–20 Standard Test Methods for Determining Radiopacity
for Medical Use.
ISO 17296–4 First edition 2014–09–01 Additive manufacturing—
General principles—Part 4: Overview of data processing.
ASTM F3268—18a Standard Guide for in vitro Degradation Testing
of Absorbable Metals.
ASTM F3303–18 Standard for additive manufacturing—Process
characteristics and performance—Practice for metal powder bed
fusion process to meet critical applications.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
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L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–39 .......................
9–131
9–44 .......................
9–132
9–53 .......................
........................
9–95 .......................
........................
9–97 .......................
........................
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ISO 8600–5 Second Edition 2020–10 Optics and photonics—Medical endoscopes and endotherapy devices—Part 5: Determination
of optical resolution of rigid endoscopes with optics.
ASTM F623–19 Standard Performance Specification for Foley Catheter.
ASTM F1992–99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes.
CENEN 1615:2000 Enteral Feeding Catheters and Enteral Giving
Sets for Single Use and their Connectors-Design and Testing.
ISO 13958 Third edition 2014–04–01 Concentrates for
haemodialysis and related therapies.
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Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
Withdrawn.
replaced
with
Withdrawn. See 9–138.
Withdrawn. See 9–136.
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Old recognition No.
Replacement
recognition
No.
9–98 .......................
........................
9–99 .......................
........................
9–100 .....................
........................
9–101 .....................
........................
9–113 .....................
........................
Title of standard 1
Change
ISO 13959 Third edition 2014–04–01 Water for haemodialysis and
related therapies.
ISO 23500 Second edition 2014–04–01 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies.
ISO 11663 Second edition 2014–04–01 Quality of dialysis fluid for
haemodialysis and related therapies.
ISO 26722 Second edition 2014–04–01 Water treatment equipment
for haemodialysis applications and related therapies.
CENEN 1618:1997 Catheters other than intravascular catheters—
Test methods for common properties.
Withdrawn. See 9–135.
Withdrawn. See 9–133.
Withdrawn. See 9–137.
Withdrawn. See 9–134.
Withdrawn. See 9–138.
M. Ophthalmic
10–35 .....................
10–122
10–72 .....................
10–123
10–79 .....................
10–124
10–81 .....................
10–125
10–90 .....................
........................
ISO 10939 Third edition 2017–05 Ophthalmic instruments—Slit-lamp
microscopes.
ISO 15004–1 Second edition 2020–5 Ophthalmic instruments—Fundamental requirements and test methods—Part 1: General requirements applicable to all ophthalmic instruments.
ISO 11979–1 Fourth edition 2018–11 Ophthalmic implants—Intraocular lenses—Part 1: Vocabulary.
ISO 11979–7 Fourth edition 2018–03 Ophthalmic implants—Intraocular lenses—Part 7: Clinical investigations of intraocular lenses
for the correction of aphakia.
ISO 11979–9 First edition 2006–09–01 Ophthalmic implants—Intraocular lenses—Part 9: Multifocal intraocular lenses [Including:
Amendment 1 (2014)].
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
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.
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
newer version.
replaced
with
Withdrawn.
N. Orthopedic
11–238 ...................
11–376
11–258 ...................
11–377
11–270 ...................
11–378
11–285 ...................
11–379
11–286 ...................
11–380
11–293 ...................
11–381
ASTM F2033–20 Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic,
Ceramic, and Polymeric Materials.
ASTM F2083–21 Standard Specification for Knee Replacement
Prosthesis.
ASTM F2502–17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants.
ASTM F2978–20 Standards Guide to Optimize Scan Sequences for
Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty
Devices using Magnetic Resonance Imaging.
ASTM F2979–20 Standard Guide for Characterization of Wear from
the Articulating Surfaces in Retrieved Metal-on-Metal and other
Hard-on-Hard Hip Prostheses.
ASTM F2582–20 Standard Test Method for Dynamic Impingement
Between Femoral and Acetabular Hip Components.
O. Physical Medicine
No new entries at this time.
khammond on DSKJM1Z7X2PROD with NOTICES
P. Radiology
12–260 ...................
12–335
12–269 ...................
12–336
12–284 ...................
12–337
12–285 ...................
12–338
12–310 ...................
12–339
VerDate Sep<11>2014
17:41 Dec 08, 2021
IEC 60336 Edition 5.0 2020–12 Medical electrical equipment—X-ray
tube assemblies for medical diagnosis—Focal spot dimensions
and related characteristics.
IEC 60601–1–3 Edition 2.2 2021–01 CONSOLIDATED VERSION
Medical electrical equipment—Part 1–3: General requirements for
basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment.
NEMA NU 1–2018 Performance Measurements of Gamma Cameras.
IEC 60601–2–1 Edition 4.0 2020–10 Medical electrical equipment—
Part 2–1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50
MeV.
IEC 60601–2–63 Edition 1.2 2021–05 CONSOLIDATED VERSION
Medical electrical equipment—Part 2–63: Particular requirements
for the basic safety and essential performance of dental extra-oral
X-ray equipment.
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Old recognition No.
Replacement
recognition
No.
12–311 ...................
12–340
Title of standard 1
Change
IEC 60601–2–65 Edition 1.2 2021–05 CONSOLIDATED VERSION
Medical electrical equipment—Part 2–65: Particular requirements
for the basic safety and essential performance of dental intra-oral
X-ray equipment.
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Withdrawn and
newer version.
replaced
with
Q. Software/Informatics
No new entries at this time.
R. Sterility
14–511 ...................
14–562
ANSI/AAMI ST79:2017 & 2020 Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive guide to steam sterilization and
sterility assurance in health care facilities.
S. Tissue Engineering
15–10 .....................
........................
15–32 .....................
15–66
15–60 .....................
15–67
1 All
ASTM F2451–05 (Reapproved 2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage.
ASTM F2260–18 Standard Test Method for Determining Degree of
Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1HNMR) Spectroscopy.
ASTM F2212–20 Standard Guide for Characterization of Type I Collagen as Starting Materials for Surgical Implants and Substrates
for Tissue Engineered Medical Products (TEMPs).
Withdrawn.
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: 056. 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
2–290 ................
2–291 ................
Biological evaluation of absorbable medical devices—Part 1: General requirements.
Biological evaluation of medical devices—Part 23: Tests for irritation ..................
ISO/TS 37137–1 First edition 2021–03.
ISO 10993–23 First edition 2021–01.
C. Cardiovascular
No new entries at this time
D. Dental/Ear, Nose, and Throat (ENT)
4–279 ................
4–280 ................
4–281. ...............
4–282 ................
4–283 ................
Part 1: Disposable Prophy Angles .........................................................................
Fluoride Varnishes ..................................................................................................
Dentistry—Shanks for rotary and oscillating instruments ......................................
Dentistry—Denture adhesives ................................................................................
Dentistry—Oral care products—Manual interdental brushes .................................
ANSI/ADA Standard No. 85–2004 (R2009).
ANSI/ADA Standard No. 117–2018.
ISO 1797 Third edition 2017–05.
ISO 10873 First edition 2010–09.
ISO 16409 Second edition 2016–10.
khammond on DSKJM1Z7X2PROD with NOTICES
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–460 ................
VerDate Sep<11>2014
Standard Specification for Barrier Face Coverings ................................................
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E:\FR\FM\09DEN1.SGM
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
H. In Vitro Diagnostics (IVD)
No new entries at this time.
I. Materials
8–558 ................
8–559 ................
8–560 ................
8–561 ................
8–562 ................
Standard Specification for Chopped Carbon Fiber Reinforced (CFR)
Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—
Tension.
Standard Test Method for Rubber Property—International Hardness ...................
Additive manufacturing—General principles—Overview of data processing .........
Additive manufacturing—Process characteristics and performance—Practice for
metal powder bed fusion process to meet critical applications.
ASTM F3333–20.
ASTM D412–16e1.
ASTM D1415–18.
ISO/ASTM 52950 First edition 2021–01.
ISO/ASTM 52904 First edition 2019–08.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–133 ................
9–134 ................
9–135 ................
9–136 ................
9–137 ................
9–138 ................
Preparation and quality management of fluids for haemodialysis and related
therapies—Part 1: General requirements.
Preparation and quality management of fluids for haemodialysis and related
therapies—Part 2: Water treatment equipment for haemodialysis applications
and related therapies.
Preparation and quality management of fluids for haemodialysis and related
therapies—Part 3: Water for haemodialysis and related therapies.
Preparation and quality management of fluids for haemodialysis and related
therapies—Part 4: Concentrates for haemodialysis and related therapies.
Preparation and quality management of fluids for haemodialysis and related
therapies—Part 5: Quality of dialysis fluid for haemodialysis and related therapies.
Enteral feeding systems—Design and testing .......................................................
ISO 23500–1 First edition 2019–02.
ISO 23500–2 First edition 2019–02.
ISO 23500–3 First edition 2019–02.
ISO 23500–4 First edition 2019–02.
ISO 23500–5 First edition 2019–02.
ISO 20695 First edition 2020–03.
M. Ophthalmic
10–126 ..............
Medical electrical equipment—Part 2–58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices
for ophthalmic surgery [Including AMENDMENT 1 (2016)].
IEC 80601–2–58 Edition 2.0 2014–09.
N. Orthopedic
11–382 ..............
11–383 ..............
11–384 ..............
Standard Test Method for Fatigue Testing of Acetabular Devices for Total Hip
Replacement.
Standard Test Method for Determination of Frictional Torque and Friction Factor
for Hip Replacement Bearings under Standard Conditions Using a Reciprocal
Friction Simulator.
Standard Test Method for Determination of Frictional Torque and Friction Factor
for Hip Implants Using an Anatomical Motion Hip Simulator.
ASTM F3090–20.
ASTM F3143–20.
ASTM F3446–20.
O. Physical Medicine
16–231 ..............
Prosthetics—Structural testing of lower-limb prostheses—Requirements and test
methods.
ISO 10328 Second edition 2016–06–01.
P. Radiology
No new entries at this time.
khammond on DSKJM1Z7X2PROD with NOTICES
Q. Software/Informatics
13–117 ..............
13–118 ..............
13–119 ..............
VerDate Sep<11>2014
Health informatics—Device interoperability Part 40101: Foundational—Cybersecurity—Processes for vulnerability assessment.
Health informatics—Device interoperability Part 40102: Foundational—Cybersecurity—Capabilities for mitigation.
Security for industrial automation and control systems Part 4–1: Product security
development life-cycle requirements..
17:41 Dec 08, 2021
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IEEE Std 11073–40101–2020.
IEEE Std 11073–40102–2020.
ANSI/ISA–62443–4–1–2018.
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Federal Register / Vol. 86, No. 234 / Thursday, December 9, 2021 / Notices
70139
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
R. Sterility
No new entries at this time.
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
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
information available at https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26635 Filed 12–8–21; 8:45 am]
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BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0125]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Establishing That a
Tobacco Product Was Commercially
Marketed in the United States as of
February 15, 2007
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on information
collection aspects of the Guidance for
Industry on Establishing That a Tobacco
Product Was Commercially Marketed in
the United States as of February 15,
2007.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by February 7, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 7,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 7, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
PO 00000
Frm 00058
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Sfmt 4703
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–
2011–D–0125 for ‘‘Guidance for
Industry on Establishing That a Tobacco
Product Was Commercially Marketed in
the United States as of February 15,
2007.’’ Received comments, those filed
in a timely manner (see ADDRESSES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
E:\FR\FM\09DEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Pages 70132-70139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26635]
-----------------------------------------------------------------------
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: 056
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: 056'' (Recognition List Number: 056), 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 December 9, 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:
[[Page 70133]]
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: 056.'' 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: 056.
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: 056 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:
056 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: 056'' 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: 056
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
[[Page 70134]]
Number: 056'' 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: 056.
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition Title of standard \1\ Change
No.
----------------------------------------------------------------------------------------------------------------
A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-115......................... 1-151 ISO 80601-2-70 Second edition 2020-11 Withdrawn and replaced
Medical electrical equipment--Part 2- with newer version.
70: Particular requirements for the
basic safety and essential performance
of sleep apnea breathing therapy
equipment.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-191......................... 2-289 ISO 10993-12 Fifth edition 2021-01 Withdrawn and replaced
Biological evaluation of medical with newer version.
devices--Part 12: Sample preparation
and reference materials.
2-241......................... .............. ISO/TR 37137 First edition 2014-05-15 Withdrawn. See 2-290.
Cardiovascular biological evaluation of
medical devices--Guidance for
absorbable implants.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-92.......................... 3-170 ISO 14708-5 Second edition 2020-05 Withdrawn and replaced
Implants for surgery--Active with newer version.
implantable medical devices--Part 5:
Circulatory support devices.
3-129......................... .............. ANSI/AAMI EC53:2013/(R)2020 ECG trunk Extent of recognition.
cables and patient leadwires.
3-166......................... .............. ISO 81060-2 Third edition 2018-11 Extent of recognition.
Noninvasive sphygmomanometers--Part 2:
Clinical investigation of intermittent
automated measurement type [Including:
Amendment 1 (2020)].
3-168......................... .............. IEEE Std 1708-2014 Standard for Extent of recognition.
Wearable, Cuffless Blood Pressure
Measuring Devices [Including: Amendment
1 (2019)].
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-105......................... .............. ANSI/ADA Standard No. 75--1997 (R2014) Withdrawn.
Resilient Lining Materials for
Removable Dentures, Part 1: Short-Term
Materials.
4-164......................... 4-273 ANSI/ASA S3.7-2016 (Reaffirmed 2020) Withdrawn and replaced
American National Standard Method for with newer version.
Measurement and Calibration of
Earphones.
4-183......................... 4-274 ANSI/ASA S3.2-2020 American National Withdrawn and replaced
Standard Method for Measuring the with newer version.
Intelligibility of Speech over
Communication Systems.
4-194......................... .............. ANSI/ADA Standard No. 78--2006 Dental Withdrawn.
obturating cones (Modified adoption of
ISO 6877-1:1995, Dental obturating
points).
4-195......................... .............. ISO 14801 Second edition 2007-11-15 Withdrawn.
Dentistry--Implants--Dynamic fatigue
test for endosseous dental implants.
4-203......................... 4-275 ANSI/ASA S3.6-2018 American National Withdrawn and replaced
Standard Specification for Audiometers. with newer version.
4-206......................... 4-276 ISO 14457 Second edition 2017-10 Withdrawn and replaced
Dentistry--Handpieces and motors. with newer version.
4-216......................... 4-277 ANSI/IEEE C63.19-2019 American National Withdrawn and replaced
Standard Methods of Measurement of with newer version.
Compatibility between Wireless
Communication Devices and Hearing Aids.
4-225......................... 4-278 ISO 4823 Fifth edition 2021-02 Withdrawn and replaced
Dentistry--Elastomeric impression and with newer version.
bite registration materials.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-23......................... 19-40 IEC 60086-4 Edition 5.0 2019-04 Primary Withdrawn and replaced
batteries--Part 4: Safety of lithium with newer version.
batteries [Including: Corrigendum 1
(2019) and Corrigendum 2 (2020)].
[[Page 70135]]
G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-385......................... 6-461 IEC 60601-2-19 Edition 3.0 2020-09 Withdrawn and replaced
Medical electrical equipment--Part 2- with newer version.
19: Particular requirements for the
basic safety and essential performance
of infant incubators.
6-386......................... 6-462 IEC 60601-2-20 Edition 3.0 2020-09 Withdrawn and replaced
Medical electrical equipment--Part 2- with newer version.
20: Particular requirements for the
basic safety and essential performance
of infant transport incubators.
6-388......................... 6-463 IEC 60601-2-21 Edition 3.0 2020-09 Withdrawn and replaced
Medical electrical equipment--Part 2- with newer version.
21: Particular requirements for the
basic safety and essential performance
of infant radiant warmers.
6-389......................... .............. IEC 60601-2-2 Edition 6.0 2017-03 Extent of recognition.
Medical electrical equipment--Part 2-2:
Particular requirements for the basic
safety and essential performance of
high frequency surgical equipment and
high frequency surgical accessories.
----------------------------------------------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-193......................... 7-306 CLSI EP06 2nd Edition Evaluation of the Withdrawn and replaced
Linearity of Quantitative Measurement with newer version.
Procedures.
7-209......................... 7-307 CLSI POCT05 2nd Edition Performance Withdrawn and replaced
Metrics for Continuous Interstitial with newer version.
Glucose Monitoring.
7-236......................... .............. CLSI M43-A October 2011 Methods for Extent of recognition.
Antimicrobial Susceptibility Testing
for Human Mycoplasmas; Approved
Guideline.
7-262......................... .............. CLSI M45 3rd Edition Methods for Extent of recognition.
Antimicrobial Dilution and Disk
Susceptibility Testing of Infrequently
Isolated or Fastidious Bacteria.
7-292......................... .............. CLSI M62 1st Edition Performance Extent of recognition.
Standards for Susceptibility Testing of
Mycobacteria, Nocardia spp., and Other
Aerobic Actinomycetes.
7-294......................... 7-308 CLSI M100 31st Edition Performance Withdrawn and replaced
Standards for Antimicrobial with newer version.
Susceptibility Testing.
----------------------------------------------------------------------------------------------------------------
I. Materials
----------------------------------------------------------------------------------------------------------------
8-394......................... 8-555 ASTM F1472-20a Standard Specification Withdrawn and replaced
for Wrought Titanium-6Aluminum- with newer version.
4Vanadium Alloy for Surgical Implant
Applications (UNS R56400).
8-418......................... 8-556 ASTM F640-20 Standard Test Methods for Withdrawn and replaced
Determining Radiopacity for Medical with newer version.
Use.
8-445......................... .............. ISO 17296-4 First edition 2014-09-01 Withdrawn. See 8-561.
Additive manufacturing--General
principles--Part 4: Overview of data
processing.
8-486......................... 8-557 ASTM F3268--18a Standard Guide for in Withdrawn and replaced
vitro Degradation Testing of Absorbable with newer version.
Metals.
8-490......................... .............. ASTM F3303-18 Standard for additive Withdrawn. See 8-562.
manufacturing--Process characteristics
and performance--Practice for metal
powder bed fusion process to meet
critical applications.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
K. Neurology
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
9-39.......................... 9-131 ISO 8600-5 Second Edition 2020-10 Optics Withdrawn and replaced
and photonics--Medical endoscopes and with newer version.
endotherapy devices--Part 5:
Determination of optical resolution of
rigid endoscopes with optics.
9-44.......................... 9-132 ASTM F623-19 Standard Performance Withdrawn and replaced
Specification for Foley Catheter. with newer version.
9-53.......................... .............. ASTM F1992-99 (Reapproved 2007) Standard Withdrawn.
Practice for Reprocessing of Reusable,
Heat-Stable Endoscopic Accessory
Instruments (EAI) Used with Flexible
Endoscopes.
9-95.......................... .............. CENEN 1615:2000 Enteral Feeding Withdrawn. See 9-138.
Catheters and Enteral Giving Sets for
Single Use and their Connectors-Design
and Testing.
9-97.......................... .............. ISO 13958 Third edition 2014-04-01 Withdrawn. See 9-136.
Concentrates for haemodialysis and
related therapies.
[[Page 70136]]
9-98.......................... .............. ISO 13959 Third edition 2014-04-01 Water Withdrawn. See 9-135.
for haemodialysis and related
therapies.
9-99.......................... .............. ISO 23500 Second edition 2014-04-01 Withdrawn. See 9-133.
Guidance for the preparation and
quality management of fluids for
haemodialysis and related therapies.
9-100......................... .............. ISO 11663 Second edition 2014-04-01 Withdrawn. See 9-137.
Quality of dialysis fluid for
haemodialysis and related therapies.
9-101......................... .............. ISO 26722 Second edition 2014-04-01 Withdrawn. See 9-134.
Water treatment equipment for
haemodialysis applications and related
therapies.
9-113......................... .............. CENEN 1618:1997 Catheters other than Withdrawn. See 9-138.
intravascular catheters--Test methods
for common properties.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-35......................... 10-122 ISO 10939 Third edition 2017-05 Withdrawn and replaced
Ophthalmic instruments--Slit-lamp with newer version.
microscopes.
10-72......................... 10-123 ISO 15004-1 Second edition 2020-5 Withdrawn and replaced
Ophthalmic instruments--Fundamental with newer version.
requirements and test methods--Part 1:
General requirements applicable to all
ophthalmic instruments.
10-79......................... 10-124 ISO 11979-1 Fourth edition 2018-11 Withdrawn and replaced
Ophthalmic implants--Intraocular with newer version.
lenses--Part 1: Vocabulary.
10-81......................... 10-125 ISO 11979-7 Fourth edition 2018-03 Withdrawn and replaced
Ophthalmic implants--Intraocular with newer version.
lenses--Part 7: Clinical investigations
of intraocular lenses for the
correction of aphakia.
10-90......................... .............. ISO 11979-9 First edition 2006-09-01 Withdrawn.
Ophthalmic implants--Intraocular
lenses--Part 9: Multifocal intraocular
lenses [Including: Amendment 1 (2014)].
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-238........................ 11-376 ASTM F2033-20 Standard Specification for Withdrawn and replaced
Total Hip Joint Prosthesis and Hip with newer version.
Endoprosthesis Bearing Surfaces Made of
Metallic, Ceramic, and Polymeric
Materials.
11-258........................ 11-377 ASTM F2083-21 Standard Specification for Withdrawn and replaced
Knee Replacement Prosthesis. with newer version.
11-270........................ 11-378 ASTM F2502-17 Standard Specification and Withdrawn and replaced
Test Methods for Absorbable Plates and with newer version.
Screws for Internal Fixation Implants.
11-285........................ 11-379 ASTM F2978-20 Standards Guide to Withdrawn and replaced
Optimize Scan Sequences for Clinical with newer version.
Diagnostic Evaluation of Metal-on-Metal
Hip Arthroplasty Devices using Magnetic
Resonance Imaging.
11-286........................ 11-380 ASTM F2979-20 Standard Guide for Withdrawn and replaced
Characterization of Wear from the with newer version.
Articulating Surfaces in Retrieved
Metal-on-Metal and other Hard-on-Hard
Hip Prostheses.
11-293........................ 11-381 ASTM F2582-20 Standard Test Method for Withdrawn and replaced
Dynamic Impingement Between Femoral and with newer version.
Acetabular Hip Components.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
12-260........................ 12-335 IEC 60336 Edition 5.0 2020-12 Medical Withdrawn and replaced
electrical equipment--X-ray tube with newer version.
assemblies for medical diagnosis--Focal
spot dimensions and related
characteristics.
12-269........................ 12-336 IEC 60601-1-3 Edition 2.2 2021-01 Withdrawn and replaced
CONSOLIDATED VERSION Medical electrical with newer version.
equipment--Part 1-3: General
requirements for basic safety and
essential performance--Collateral
Standard: Radiation protection in
diagnostic X-ray equipment.
12-284........................ 12-337 NEMA NU 1-2018 Performance Measurements Withdrawn and replaced
of Gamma Cameras. with newer version.
12-285........................ 12-338 IEC 60601-2-1 Edition 4.0 2020-10 Withdrawn and replaced
Medical electrical equipment--Part 2-1: with newer version.
Particular requirements for the basic
safety and essential performance of
electron accelerators in the range 1
MeV to 50 MeV.
12-310........................ 12-339 IEC 60601-2-63 Edition 1.2 2021-05 Withdrawn and replaced
CONSOLIDATED VERSION Medical electrical with newer version.
equipment--Part 2-63: Particular
requirements for the basic safety and
essential performance of dental extra-
oral X-ray equipment.
[[Page 70137]]
12-311........................ 12-340 IEC 60601-2-65 Edition 1.2 2021-05 Withdrawn and replaced
CONSOLIDATED VERSION Medical electrical with newer version.
equipment--Part 2-65: Particular
requirements for the basic safety and
essential performance of dental intra-
oral X-ray equipment.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
R. Sterility
----------------------------------------------------------------------------------------------------------------
14-511........................ 14-562 ANSI/AAMI ST79:2017 & 2020 Amendments Withdrawn and replaced
A1, A2, A3, A4 (Consolidated Text) with newer version.
Comprehensive guide to steam
sterilization and sterility assurance
in health care facilities.
----------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-10......................... .............. ASTM F2451-05 (Reapproved 2010) Standard Withdrawn.
Guide for in vivo Assessment of
Implantable Devices Intended to Repair
or Regenerate Articular Cartilage.
15-32......................... 15-66 ASTM F2260-18 Standard Test Method for Withdrawn and replaced
Determining Degree of Deacetylation in with newer version.
Chitosan Salts by Proton Nuclear
Magnetic Resonance (1HNMR)
Spectroscopy.
15-60......................... 15-67 ASTM F2212-20 Standard Guide for Withdrawn and replaced
Characterization of Type I Collagen as with newer version.
Starting Materials for Surgical
Implants and Substrates for Tissue
Engineered Medical Products (TEMPs).
----------------------------------------------------------------------------------------------------------------
\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: 056. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
2-290............................ Biological evaluation of absorbable medical devices-- ISO/TS 37137-1 First edition 2021-03.
Part 1: General requirements.
2-291............................ Biological evaluation of medical devices--Part 23: ISO 10993-23 First edition 2021-01.
Tests for irritation.
--------------------------------------------------------------------------------------------------------------------------------------------------------
C. Cardiovascular
No new entries at this time
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
--------------------------------------------------------------------------------------------------------------------------------------------------------
4-279............................ Part 1: Disposable Prophy Angles.................... ANSI/ADA Standard No. 85-2004 (R2009).
4-280............................ Fluoride Varnishes.................................. ANSI/ADA Standard No. 117-2018.
4-281............................ Dentistry--Shanks for rotary and oscillating ISO 1797 Third edition 2017-05.
instruments.
4-282............................ Dentistry--Denture adhesives........................ ISO 10873 First edition 2010-09.
4-283............................ Dentistry--Oral care products--Manual interdental ISO 16409 Second edition 2016-10.
brushes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
--------------------------------------------------------------------------------------------------------------------------------------------------------
6-460............................ Standard Specification for Barrier Face Coverings... ASTM F3502-21.
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 70138]]
H. In Vitro Diagnostics (IVD)
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Materials
--------------------------------------------------------------------------------------------------------------------------------------------------------
8-558............................ Standard Specification for Chopped Carbon Fiber ASTM F3333-20.
Reinforced (CFR) Polyetheretherketone (PEEK)
Polymers for Surgical Implant Applications.
8-559............................ Standard Test Methods for Vulcanized Rubber and ASTM D412-16e1.
Thermoplastic Elastomers--Tension.
8-560............................ Standard Test Method for Rubber Property-- ASTM D1415-18.
International Hardness.
8-561............................ Additive manufacturing--General principles--Overview ISO/ASTM 52950 First edition 2021-01.
of data processing.
8-562............................ Additive manufacturing--Process characteristics and ISO/ASTM 52904 First edition 2019-08.
performance--Practice for metal powder bed fusion
process to meet critical applications.
--------------------------------------------------------------------------------------------------------------------------------------------------------
J. Nanotechnology
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
K. Neurology
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
--------------------------------------------------------------------------------------------------------------------------------------------------------
9-133............................ Preparation and quality management of fluids for ISO 23500-1 First edition 2019-02.
haemodialysis and related therapies--Part 1:
General requirements.
9-134............................ Preparation and quality management of fluids for ISO 23500-2 First edition 2019-02.
haemodialysis and related therapies--Part 2: Water
treatment equipment for haemodialysis applications
and related therapies.
9-135............................ Preparation and quality management of fluids for ISO 23500-3 First edition 2019-02.
haemodialysis and related therapies--Part 3: Water
for haemodialysis and related therapies.
9-136............................ Preparation and quality management of fluids for ISO 23500-4 First edition 2019-02.
haemodialysis and related therapies--Part 4:
Concentrates for haemodialysis and related
therapies.
9-137............................ Preparation and quality management of fluids for ISO 23500-5 First edition 2019-02.
haemodialysis and related therapies--Part 5:
Quality of dialysis fluid for haemodialysis and
related therapies.
9-138............................ Enteral feeding systems--Design and testing......... ISO 20695 First edition 2020-03.
--------------------------------------------------------------------------------------------------------------------------------------------------------
M. Ophthalmic
--------------------------------------------------------------------------------------------------------------------------------------------------------
10-126........................... Medical electrical equipment--Part 2-58: Particular IEC 80601-2-58 Edition 2.0 2014-09.
requirements for basic safety and essential
performance of lens removal devices and vitrectomy
devices for ophthalmic surgery [Including AMENDMENT
1 (2016)].
--------------------------------------------------------------------------------------------------------------------------------------------------------
N. Orthopedic
--------------------------------------------------------------------------------------------------------------------------------------------------------
11-382........................... Standard Test Method for Fatigue Testing of ASTM F3090-20.
Acetabular Devices for Total Hip Replacement.
11-383........................... Standard Test Method for Determination of Frictional ASTM F3143-20.
Torque and Friction Factor for Hip Replacement
Bearings under Standard Conditions Using a
Reciprocal Friction Simulator.
11-384........................... Standard Test Method for Determination of Frictional ASTM F3446-20.
Torque and Friction Factor for Hip Implants Using
an Anatomical Motion Hip Simulator.
--------------------------------------------------------------------------------------------------------------------------------------------------------
O. Physical Medicine
--------------------------------------------------------------------------------------------------------------------------------------------------------
16-231........................... Prosthetics--Structural testing of lower-limb ISO 10328 Second edition 2016-06-01.
prostheses--Requirements and test methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
P. Radiology
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
--------------------------------------------------------------------------------------------------------------------------------------------------------
13-117........................... Health informatics--Device interoperability Part IEEE Std 11073-40101-2020.
40101: Foundational--Cybersecurity--Processes for
vulnerability assessment.
13-118........................... Health informatics--Device interoperability Part IEEE Std 11073-40102-2020.
40102: Foundational--Cybersecurity--Capabilities
for mitigation.
13-119........................... Security for industrial automation and control ANSI/ISA-62443-4-1-2018.
systems Part 4-1: Product security development life-
cycle requirements..
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 70139]]
R. Sterility
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
S. Tissue Engineering
No new entries at this time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 All standard titles in this table conform to the style requirements of the respective organizations
IV. List of Recognized Standards
FDA maintains the current list of FDA Recognized Consensus
Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has recognized by notice published in the
Federal Register or that FDA has decided to recognize but for which
recognition is pending (because a periodic notice has not yet appeared
in the Federal Register). FDA will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
[email protected]. To be considered, such recommendations
should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26635 Filed 12-8-21; 8:45 am]
BILLING CODE 4164-01-P
