Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055, 22678-22686 [2021-08992]
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Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
directions for use). We assume that
designing, testing, and producing each
label will take 30 minutes (0.5 hours) for
each repackaged radiopharmaceutical,
for a total of 5 hours. We consider that
the provision to include ‘‘https://
www.fda.gov/medwatch’’ and ‘‘1–800–
FDA–1088’’ is not a collection of
information as defined in 5 CFR
1320.3(c)(2) and is therefore exempt
from OMB review and approval under
the PRA.
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Repackaging Guidance
Based on current data for outsourcing
facilities, we estimate 6 outsourcing
facilities annually will submit an initial
report identifying all drugs repackaged
in the facility in the previous year. For
the purposes of this estimate, each
product’s structured product labeling
(SPL) submission is considered a
separate response and therefore each
facility’s product report will include
multiple responses. Taking into account
that a particular product that is
repackaged may come in different
strengths and can be reported in a single
SPL response, we estimate that each
facility will average approximately 6
products.
Similarly, we estimate that 6
outsourcing facilities will submit an
initial report identifying all drugs
repackaged in the facility in the past
year. Taking into account that a
particular product that is repackaged
may come in different strengths and can
be reported in a single SPL response, we
assume that each facility will average 6
products. Our estimate is based on
current product reporting data. We
expect that each product report will
consist of multiple SPL responses per
facility and assume preparing and
electronically submitting this
information will take up to 2 hours for
each initial SPL response.
We also estimate 3 registered
outsourcing facilities will submit a
report twice each year (June and
December) that identifies all drugs
repackaged at the facility in the
previous 6 months. We also estimate
that an average of 3 facilities will
prepare and submit 3 SPL responses and
assume that preparing and submitting
this information electronically will take
2 hours per response. If a product was
not repackaged during a particular
reporting period, outsourcing facilities
do not need to send an SPL response for
that product during that reporting
period. We expect to receive no waiver
requests from the electronic submission
process for initial product reports and
semiannual reports.
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Biologics Guidance
We estimate 15 outsourcing facilities
annually who mix, dilute, or repackage
biological products will each design,
test, and produce 5 different labels, for
a total of 75 labels that include the
information set forth in section III.B—
‘‘Mixing, Diluting, or Repackaging
Licensed Biological Products’’ of the
guidance (including directions for use)
as well as inclusion of storage
instructions, handling instructions, or
both. We assume that designing, testing,
and producing each label will take 30
minutes (0.5 hours). We consider that
the provision to include ‘‘https://
www.fda.gov/medwatch’’ and ‘‘1–800–
FDA–1088’’ is not a collection of
information as defined in 5 CFR
1320.3(c)(2) and is therefore exempt
from OMB review and approval under
the PRA.
We estimate that annually a total of 5
outsourcing facilities who prepare
prescription sets will each include on
the labels, packages, and/or containers
of approximately 300 prescription sets
the information set forth in section III.C
‘‘Licensed Allergenic Extracts for
Subcutaneous Immunotherapy’’ of the
draft guidance (including directions for
use), for a total of 1,500 disclosures. We
assume the initial process of designing,
testing, and producing labeling and
attaching to each prescription set each
label, package, and/or container will
take approximately 30 minutes (0.5
hours), for a total of approximately 750
hours.
Finally, we estimate that annually five
outsourcing facilities who repackage
biological products and establish a BUD
in accordance with Appendix A—
‘‘Assigning a BUD for Repackaged
Biological Products Based On Stability
Testing’’ will maintain 150 records of
the testing, as described in Appendix A
of the guidance. We assume maintaining
the records will take 5 minutes per
record, for a total of 12.5 hours.
Our estimated burden for the
information collection reflects program
changes and adjustments. We are
changing the scope of the information
collection to include burden attendant
to provisions found in the Agency
guidance documents discussed in this
notice and have adjusted our estimate to
reflect a resulting increase of 955 hours
and 1,873 responses annually.
Dated: April 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08943 Filed 4–28–21; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
055
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: 055’’
(Recognition List Number: 055), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
April 29, 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:
• 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
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Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
jbell on DSKJLSW7X2PROD with NOTICES
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: 055.’’ 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: 055.
• 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
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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: 055 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: 055
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: 055’’ 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
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22679
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: 055
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: 055’’ 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: 055.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Anesthesiology
1–79 ...........
1–147
1–102 .........
1–148
1–123 .........
1–149
1–125 .........
1–150
1–146 .........
........................
ISO 26825 Second edition 2020–10 Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during
anaesthesia—Colours, design and performance.
ISO 80601–2–69 Second edition 2020–11 Medical electrical equipment—
Part 2–69: Particular requirements for the basic safety and essential
performance of oxygen concentrator equipment.
ISO 7376 Third edition 2020–08 Anaesthetic and respiratory equipment—
Laryngoscopes for tracheal intubation.
ISO 8836 Fifth edition 2019–12 Suction catheters for use in the respiratory tract.
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 replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Transition period extended.
B. Biocompatibility
2–119 .........
2–277
2–122 .........
2–278
2–124 .........
2–279
2–133 .........
2–280
2–167 .........
2–281
2–205 .........
2–282
2–214 .........
2–283
2–269 .........
2–284
2–270 .........
2–285
2–271 .........
2–286
ASTM F813–20 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices.
ASTM F719–20 e1 Standard Practice for Testing Materials in Rabbits for
Primary Skin Irritation.
ASTM F750–20 Standard Practice for Evaluating Acute Systemic Toxicity
of Material Extracts by Systemic Injection in the Mouse.
ASTM F1408–20a Standard Practice for Subcutaneous Screening Test
for Implant Materials.
ISO 10993–19 Second edition 2020–03 Biological evaluation of medical
devices—Part 19: Physico-chemical, morphological and topographical
characterization of materials.
ISO 14155 Third edition 2020–07 Clinical investigation of medical devices
for human subjects—Good clinical practice.
ASTM F619–20 Standard Practice for Extraction of Materials Used in
Medical Devices.
USP 43–NF38:2020 <87> Biological Reactivity Test, In Vitro—Direct
Contact Test.
USP 43–NF38:2020 <87> Biological Reactivity Test, In Vitro—Elution
Test.
USP 43–NF38:2020 <88> Biological Reactivity Tests, In Vivo ...................
2–272 .........
2–287
USP 43–NF38:2020 <151> Pyrogen Test (USP Rabbit Test) ....................
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
C. Cardiovascular
No new entries at this time.
D. Dental/Ear, Nose, and Throat (ENT)
4–92 ...........
4–264
ANSI/ADA Standard No. 88—2019 Dental Brazing Alloys .........................
4–243 .........
........................
4–245 .........
4–265
ISO 10271 First edition 2001–06 Dental metallic materials—Corrosion
test methods.
ISO 10271 Third edition 2020–08 Dentistry—Corrosion test methods for
metallic materials.
Withdrawn and replaced with newer
version.
Withdrawn.
Withdrawn and replaced with newer
version.
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E. General I (Quality Systems/Risk Management) (QS/RM)
5–76 ...........
5–131
5–89 ...........
5–132
5–115 .........
5–133
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IEC 60601–1–8 Edition 2.2 2020–07 CONSOLIDATED VERSION Medical electrical equipment—Part 1–8: General requirements for basic
safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems.
IEC 60601–1–6 Edition 3.2 2020–07 CONSOLIDATED VERSION Medical electrical equipment—Part 1–6: General requirements for basic
safety and essential performance—Collateral standard: Usability.
ISO 80369–7 Second edition 2021 Small-bore connectors for liquids and
gases in healthcare applications—Part 7: Connectors for intravascular
or hypodermic applications.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–8 ...........
19–36
19–9 ...........
19–37
19–14 .........
19–38
19–15 .........
19–39
IEC 60601–1–2 Edition 4.1 2020–09 CONSOLIDATED VERSION Medical electrical equipment—Part 1–2: General requirements for basic
safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests.
IEC 60601–1–10 Edition 1.2 2020–07 CONSOLIDATED VERSION Medical electrical equipment—Part 1–10: General requirements for basic
safety and essential performance—Collateral Standard: Requirements
for the development of physiologic closed-loop controllers.
IEC 60601–1–11 Edition 2.1 2020–07 CONSOLIDATED VERSION Medical electrical equipment—Part 1–11: General requirements for basic
safety and essential performance—Collateral Standard: Requirements
for medical electrical equipment and medical electrical systems used in
the home healthcare environment.
IEC 60601–1–12 Edition 1.1 2020–07 CONSOLIDATED VERSION Medical electrical equipment—Part 1–12: General requirements for basic
safety and essential performance—Collateral Standard: Requirements
for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–11 ...........
........................
6–129 .........
........................
6–180 .........
6–448
6–339 .........
6–449
6–340 .........
........................
6–387 .........
6–450
6–428 .........
6–451
ISO 594–1 First edition 1986–06–15 Conical fittings with a 6% (Luer)
taper for syringes, needles and certain other medical equipment—Part
1: General requirements.
ISO 594–2 Second edition 1998–09–01 Conical fittings with a 6% (Luer)
taper for syringes, needles and certain other medical equipment—Part
2: Lock fittings.
ASTM F2407–20 Standard Specification for Surgical Gowns Intended for
Use in Healthcare Facilities.
ASTM F1169–19 Standard Consumer Safety Specification for Full-Size
Baby Cribs.
ASTM F2710–13 Standard Consumer Safety Performance Specification
for Commercial Cribs.
IEC 60601–2–50 Ed. 3.0 2020–09 Medical electrical equipment—Part 2–
50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment.
USP 43–NF38:2020 Sodium Chloride Irrigation ..........................................
6–429 .........
6–452
USP 43–NF38:2020 Sodium Chloride Injection ..........................................
6–430 .........
6–453
USP 43–NF38:2020 Nonabsorbable Surgical Suture .................................
6–431 .........
6–454
USP 43–NF38:2020 <881> Tensile Strength ..............................................
6–432 .........
6–455
USP 43–NF38:2020 <861> Sutures—Diameter ..........................................
6–433 .........
6–456
USP 43–NF38:2020 <871> Sutures—Needle Attachment .........................
6–434 .........
6–457
USP 43–NF38:2020 Sterile Water for Irrigation ..........................................
6–435 .........
6–458
USP 43–NF38:2020 Heparin Lock Flush Solution ......................................
6–436 .........
6–459
USP 43–NF38:2020 Absorbable Surgical Suture .......................................
Withdrawn. See 5–133.
Withdrawn. See 5–133.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn.
Withdrawn and replaced with newer
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
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H. In Vitro Diagnostics (IVD)
7–101 .........
........................
7–112 .........
7–299
7–131 .........
........................
7–135 .........
........................
7–142 .........
........................
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CLSI H51–A Assays of von Willebrand Factor Antigen and Ristocetin Cofactor Activity; Approved Guideline.
CLSI POCT14 2nd Edition Point-of-Care Coagulation Testing and
Anticoagulation Monitoring.
CLSI I/LA18–A2 (Replaces I/LA18–A) Specifications for Immunological
Testing for Infectious Diseases; Approved Guideline—Second Edition.
CLSI H44–A2 (Replaces H44–A) Methods for Reticulocyte Counting
(Automated Blood Cell Counters, Flow Cytometry, and Supravital
Dyes); Approved Guideline—Second Edition.
CLSI GP43–A4 (Formerly H11–A4) Procedures for the Collection of Arterial Blood Specimens; Approved Standard—Fourth Edition.
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Withdrawn.
Withdrawn and replaced with newer
version.
Withdrawn.
Withdrawn.
Withdrawn.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
7–146 .........
........................
7–164 .........
........................
7–173 .........
........................
7–191 .........
7–300
7–203 .........
7–301
7–211 .........
7–302
7–217 .........
7–303
7–261 .........
7–304
Title of standard 1
Change
CLSI M06–A2 Protocols for Evaluating Dehydrated Mueller-Hinton Agar;
Approved Standard—Second Edition.
CLSI GP28–A (Replaces GP28–P) Microwave Device Use in the Histology Laboratory; Approved Guideline.
CLSI C44–A (Replaces C44–P) Harmonization of Glycohemoglobin
Measurements; Approved Guideline.
CLSI MM13 2nd Edition Collection, Transport, Preparation, and Storage
of Specimens for Molecular Methods.
CLSI GP42 7th Edition Collection of Capillary Blood Specimens ...............
CLSI C34 4th Edition Sweat Testing: Specimen Collection and Quantitative Chloride Analysis.
CLSI M60 2nd Edition Performance Standards for Antifungal Susceptibility Testing of Yeast.
CLSI M23 5th Edition Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters.
Withdrawn.
Withdrawn.
Withdrawn.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
I. Materials
8–217 .........
8–537
8–223 .........
8–538
8–338 .........
8–539
8–339 .........
8–540
8–342 .........
8–541
8–348 .........
8–542
8–361 .........
8–543
8–395 .........
8–544
8–416 .........
8–545
8–417 .........
8–546
8–421 .........
8–547
8–438 .........
8–548
8–530 .........
8–549
ASTM F620–20 Standard Specification for Titanium Alloy Forgings for
Surgical Implants in the Alpha Plus Beta Condition.
ASTM F2759–19 Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices.
ASTM F139–19 Standard Specification for Wrought 18Chromium14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical
Implants (UNS S31673).
ASTM F1091–20 Standard Specification for Wrought Cobalt20Chromium-15Tungsten-10Nickel Alloy Surgical Fixation Wire (UNS
R30605).
ASTM F1537–20 Standard Specification for Wrought Cobalt28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537,
UNS R31538, and UNS R31539).
ASTM F138–19 Standard Specification for Wrought 18Chromium14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
ASTM F755–19 Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants.
ASTM F961–20 Standard Specification for 35Cobalt-35Nickel20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS
R30035).
ASTM F2977–20 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants.
ASTM F3044–20 Standard Test Method for Evaluating the Potential for
Galvanic Corrosion for Medical Implants.
ASTM F629–20 Standard Practice for Radiography of Cast Metallic Surgical Implants.
ISO/ASTM 52915 Third edition 2020–03 Specification for additive manufacturing file format (AMF) Version 1.2.
ASTM F3208–20 Standard Guide for Selecting Test Soils for Validation
of Cleaning Methods for Reusable Medical Devices.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
jbell on DSKJLSW7X2PROD with NOTICES
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–40 ...........
9–130
ISO 8600–6: Second Edition 2020–09 Endoscopes—Medical endoscopes
and endotherapy devices—Part 6: Vocabulary.
Withdrawn and replaced with newer
version.
M. Ophthalmic
10–48 .........
VerDate Sep<11>2014
10–119
18:32 Apr 28, 2021
ISO 11979–5 Third edition 2020–09 Ophthalmic implants—Intraocular
Lenses—Part 5: Biocompatibility.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
10–63 .........
Replacement
recognition
No.
10–120
Title of standard 1
Change
ISO/TR 22979 Second Edition 2017–05 Ophthalmic implants—Intraocular
Lenses—Guidance on assessment of the need for clinical investigation
of intraocular lens design modifications.
Withdrawn and replaced with newer
version.
N. Orthopedic
11–191 .......
11–370
11–267 .......
11–371
11–279 .......
11–372
11–282 .......
11–373
11–313 .......
11–374
11–330 .......
11–332 .......
11–375
ISO 14879–1 Second edition 2020–07 Implants for surgery—Total kneejoint prostheses—Part 1: Determination of endurance properties of
knee tibial trays.
ASTM F2009–20 Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
ASTM F2996–20 Standard Practice for Finite Element Analysis (FEA) of
Non-Modular Metallic Orthopaedic Hip Femoral Stems.
ASTM F1223–20 Standard Test Method for Determination of Total Knee
Replacement Constraint.
ISO 7207–2 Second edition 2011–07–01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating
surfaces made of metal, ceramic and plastics materials [Including
AMENDMENT 1 (2016) and AMENDMENT 2 (2020)].
ASTM F2028–17 Standard Test Methods for Dynamic Evaluation of
Glenoid Loosening or Disassociation.
ASTM F2193–20 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
Withdrawn and replaced with newer
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
Extent of recognition.
Withdrawn and replaced with newer
version.
O. Physical Medicine
No new entries at this time.
P. Radiology
No new entries at this time.
Q. Software/Informatics
No new entries at this time.
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R. Sterility
14–314 .......
14–550
14–361 .......
14–551
14–411 .......
14–552
14–498 .......
14–553
14–519 .......
14–554
14–534 .......
14–555
14–535 .......
14–556
14–536 .......
14–557
14–537 .......
14–558
14–546 .......
14–559
14–547 .......
14–560
USP 43–NF38:2020 <61≤ Microbiological Examination of Nonsterile
Products: Microbial Enumeration Tests.
USP 43–NF38:2020 <71≤ Sterility Tests .....................................................
14–548 .......
14–561
USP 43–NF38:2020 <85≤ Bacterial Endotoxins Test .................................
VerDate Sep<11>2014
18:32 Apr 28, 2021
ANSI/AAMI ST67:2019 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for
products labeled ‘‘sterile’’.
ISO 14160 Third edition 2020–09 Sterilization of health care products—
Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization
process for medical devices.
ISO/ASTM 51818 Fourth edition 2020–06 Practice for dosimetry in an
electron beam facility for radiation processing at energies between 80
and 300 keV.
ASTM F2097–20 Standard Guide for Design and Evaluation of Primary
Flexible Packaging for Medical Products.
ASTM F17–20 Standard Terminology Relating to Primary Barrier Packaging.
USP 43–NF38:2020 <161≤ Medical Devices-Bacterial Endotoxin and
Pyrogen Tests.
USP 43–NF38:2020 <62≤ Microbiological Examination of Nonsterile
Products: Tests for Specified Microorganisms.
USP 43–NF38:2020 <55≤ Biological Indicators—Resistance Performance
Tests.
USP 43–NF38:2020 <1229.5≤ Biological Indicators for Sterilization ..........
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version.
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version.
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22684
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
S. Tissue Engineering
15–35 .........
........................
15–36 .........
........................
15–38 .........
........................
15–45 .........
15–64
15–46 .........
15–65
1 All
ASTM F2900–11 Standard Guide for Characterization of Hydrogels used
in Regenerative Medicine.
ASTM F2383–11 Standard Guide for Assessment of Adventitious Agents
in Tissue Engineered Medical Products (TEMPs).
ASTM F2883–11 Standard Guide for Characterization of Ceramic and
Mineral Based Scaffolds used for Tissue-Engineered Medical Products
(TEMPs) and as Device for Surgical Implant Applications.
ISO 22442–1 Third edition 2020–09 Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management.
ISO 22442–2 Third edition 2020–09 Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and
handling.
Withdrawn.
Withdrawn.
Withdrawn.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
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: 055. 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
2–288 ..........
Biological evaluation of medical devices—Part 15: Identification and quantification of
degradation products from metals and alloys.
ISO 10993–15 Second edition 2019–11.
C. Cardiovascular
3–169 ..........
Medical electrical equipment—Part 2–4: Particular requirements for the basic safety
and essential performance of cardiac defibrillators.
IEC Edition 3.1 2018–02
DATED VERSION.
CONSOLI-
D. Dental/Ear, Nose, and Throat (ENT)
4–266
4–267
4–268
4–269
..........
..........
..........
..........
4–270 ..........
4–271 ..........
4–272 ..........
Dentistry—Orthodontic anchor screws ..........................................................................
Dentistry—Elastomeric auxiliaries for use in orthodontics ............................................
Dentistry—Wires for use in orthodontics [Including AMENDMENT 1 (2020)] ..............
Dentistry—Coupling dimensions for handpiece connectors [Including AMENDMENT
1 (2018)].
CAD/CAM Abutments in Dentistry .................................................................................
Dental Cartridge Syringes ..............................................................................................
Root Canal Barbed Broaches and Rasps. ....................................................................
ISO
ISO
ISO
ISO
19023 First edition 2018–02.
21606 First edition 2007–06.
15841 Second edition 2014–08.
3964 Third edition 11–2016.
ADA Technical Report No. 146–2018.
ANSI/ADA Standard No. 34–2013.
ANSI/ADA Standard No. 63–2013.
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.
jbell on DSKJLSW7X2PROD with NOTICES
G. General Hospital/General Plastic Surgery (GH/GPS)
No new entries at this time.
H. In Vitro Diagnostics (IVD)
7–305 ..........
VerDate Sep<11>2014
In vitro diagnostic medical devices—Requirements for establishing metrological
traceability of values assigned to calibrators, trueness control materials and
human samples..
18:32 Apr 28, 2021
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ISO 17511 Second edition 2020–04.
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22685
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition
No.
Title of standard 1
Reference No. and date
I. Materials
8–550 ..........
8–551 ..........
8–552 ..........
8–553 ..........
8–554 ..........
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants.
Standard Practice for Digital Radiography of Cast Metallic Implants ...........................
Guide for Additive manufacturing—Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production
Manufacturing New publication.
Additive manufacturing—Material extrusion-based additive manufacturing of plastic
materials—Part 1: Feedstock materials.
Additive manufacturing—Design—Functionally graded additive manufacturing ...........
ASTM F2181–20.
ASTM F2895–20.
ASTM F3434–20.
ISO/ASTM 52903–1 First edition 2020–04.
ISO/ASTM TR 52912 First edition 2020–
09.
J. Nanotechnology
18–17 ..........
18–18 ..........
Nanotechnologies—Measurements of particle size and shape distributions by transmission electron microscopy.
Standard Test Method for Measuring the Size of Nanoparticles in Aqueous Media
Using Dynamic Light Scattering.
ISO 21363 First edition 2020–06.
ASTM E3247–20.
K. Neurology
17–17 ..........
Standard Specification for Neurosurgical Head Holder Devices ...................................
ASTM F3395/F3395M–19.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
10–121 ........
Ophthalmic implants—Ocular endotamponades ...........................................................
ISO 16672 Third edition 2020–06.
N. Orthopedic
No new entries at this time.
O. Physical Medicine
16–230 ........
American National Standard for Wheelchairs—Volume 2: Additional Requirements
for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries
and Chargers for Powered Wheelchairs.
ANSI/RESNA WC–2:2019 Section 25.
P. Radiology
No new entries at this time.
Q. Software/Informatics
13–116 ........
Common Vulnerability Scoring System version 3.0 ......................................................
FIRST CVSS v3.0.
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
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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
VerDate Sep<11>2014
18:32 Apr 28, 2021
Jkt 253001
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
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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
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Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
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: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08992 Filed 4–28–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0363]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prescription Drug
Advertising
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
jbell on DSKJLSW7X2PROD with NOTICES
18:32 Apr 28, 2021
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
The Food and Drug
Administration (FDA or Agency) 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 associated with prescription
drug advertising.
DATES: Submit either electronic or
written comments on the collection of
information by June 28, 2021.
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 June 28, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 28, 2021. 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.
SUMMARY:
VerDate Sep<11>2014
Electronic Submissions
Jkt 253001
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–
2021–N–0363 for ‘‘Prescription Drug
Advertising.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), 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.
• 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
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Fmt 4703
Sfmt 4703
‘‘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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22678-22686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08992]
-----------------------------------------------------------------------
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: 055
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: 055'' (Recognition List Number: 055), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable April 29, 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
[[Page 22679]]
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: 055.'' 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: 055.
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: 055 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:
055 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: 055'' 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: 055
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: 055'' 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: 055.
[[Page 22680]]
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Old Replacement
recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-79........... 1-147 ISO 26825 Second Withdrawn and
edition 2020-10 replaced with
Anaesthetic and newer version.
respiratory
equipment--User-
applied labels for
syringes containing
drugs used during
anaesthesia--Colours
, design and
performance.
1-102.......... 1-148 ISO 80601-2-69 Second Withdrawn and
edition 2020-11 replaced with
Medical electrical newer version.
equipment--Part 2-
69: Particular
requirements for the
basic safety and
essential
performance of
oxygen concentrator
equipment.
1-123.......... 1-149 ISO 7376 Third Withdrawn and
edition 2020-08 replaced with
Anaesthetic and newer version.
respiratory
equipment--Laryngosc
opes for tracheal
intubation.
1-125.......... 1-150 ISO 8836 Fifth Withdrawn and
edition 2019-12 replaced with
Suction catheters newer version.
for use in the
respiratory tract.
1-146.......... .............. ISO 80601-2-12 Second Transition
edition 2020-02 period
Medical electrical extended.
equipment--Part 2-
12: Particular
requirements for
basic safety and
essential
performance of
critical care
ventilators.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-119.......... 2-277 ASTM F813-20 Standard Withdrawn and
Practice for Direct replaced with
Contact Cell Culture newer version.
Evaluation of
Materials for
Medical Devices.
2-122.......... 2-278 ASTM F719-20 [egr]1 Withdrawn and
Standard Practice replaced with
for Testing newer version.
Materials in Rabbits
for Primary Skin
Irritation.
2-124.......... 2-279 ASTM F750-20 Standard Withdrawn and
Practice for replaced with
Evaluating Acute newer version.
Systemic Toxicity of
Material Extracts by
Systemic Injection
in the Mouse.
2-133.......... 2-280 ASTM F1408-20a Withdrawn and
Standard Practice replaced with
for Subcutaneous newer version.
Screening Test for
Implant Materials.
2-167.......... 2-281 ISO 10993-19 Second Withdrawn and
edition 2020-03 replaced with
Biological newer version.
evaluation of
medical devices--
Part 19: Physico-
chemical,
morphological and
topographical
characterization of
materials.
2-205.......... 2-282 ISO 14155 Third Withdrawn and
edition 2020-07 replaced with
Clinical newer version.
investigation of
medical devices for
human subjects--Good
clinical practice.
2-214.......... 2-283 ASTM F619-20 Standard Withdrawn and
Practice for replaced with
Extraction of newer version.
Materials Used in
Medical Devices.
2-269.......... 2-284 USP 43-NF38:2020 <87> Withdrawn and
Biological replaced with
Reactivity Test, In newer version.
Vitro--Direct
Contact Test.
2-270.......... 2-285 USP 43-NF38:2020 <87> Withdrawn and
Biological replaced with
Reactivity Test, In newer version.
Vitro--Elution Test.
2-271.......... 2-286 USP 43-NF38:2020 <88> Withdrawn and
Biological replaced with
Reactivity Tests, In newer version.
Vivo.
2-272.......... 2-287 USP 43-NF38:2020 Withdrawn and
<151> Pyrogen Test replaced with
(USP Rabbit Test). newer version.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-92........... 4-264 ANSI/ADA Standard No. Withdrawn and
88--2019 Dental replaced with
Brazing Alloys. newer version.
4-243.......... .............. ISO 10271 First Withdrawn.
edition 2001-06
Dental metallic
materials--Corrosion
test methods.
4-245.......... 4-265 ISO 10271 Third Withdrawn and
edition 2020-08 replaced with
Dentistry--Corrosion newer version.
test methods for
metallic materials.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-76........... 5-131 IEC 60601-1-8 Edition Withdrawn and
2.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-8:
General requirements
for basic safety and
essential
performance--Collate
ral standard:
General
requirements, tests
and guidance for
alarm systems in
medical electrical
equipment and
medical electrical
systems.
5-89........... 5-132 IEC 60601-1-6 Edition Withdrawn and
3.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-6:
General requirements
for basic safety and
essential
performance--Collate
ral standard:
Usability.
5-115.......... 5-133 ISO 80369-7 Second Withdrawn and
edition 2021 Small- replaced with
bore connectors for newer version.
liquids and gases in
healthcare
applications--Part
7: Connectors for
intravascular or
hypodermic
applications.
------------------------------------------------------------------------
[[Page 22681]]
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-8........... 19-36 IEC 60601-1-2 Edition Withdrawn and
4.1 2020-09 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-2:
General requirements
for basic safety and
essential
performance--Collate
ral Standard:
Electromagnetic
disturbances--Requir
ements and tests.
19-9........... 19-37 IEC 60601-1-10 Withdrawn and
Edition 1.2 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
10: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for the
development of
physiologic closed-
loop controllers.
19-14.......... 19-38 IEC 60601-1-11 Withdrawn and
Edition 2.1 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
11: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for
medical electrical
equipment and
medical electrical
systems used in the
home healthcare
environment.
19-15.......... 19-39 IEC 60601-1-12 Withdrawn and
Edition 1.1 2020-07 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 1-
12: General
requirements for
basic safety and
essential
performance--Collate
ral Standard:
Requirements for
medical electrical
equipment and
medical electrical
systems intended for
use in the emergency
medical services
environment.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-11........... .............. ISO 594-1 First Withdrawn. See 5-
edition 1986-06-15 133.
Conical fittings
with a 6% (Luer)
taper for syringes,
needles and certain
other medical
equipment--Part 1:
General requirements.
6-129.......... .............. ISO 594-2 Second Withdrawn. See 5-
edition 1998-09-01 133.
Conical fittings
with a 6% (Luer)
taper for syringes,
needles and certain
other medical
equipment--Part 2:
Lock fittings.
6-180.......... 6-448 ASTM F2407-20 Withdrawn and
Standard replaced with
Specification for newer version.
Surgical Gowns
Intended for Use in
Healthcare
Facilities.
6-339.......... 6-449 ASTM F1169-19 Withdrawn and
Standard Consumer replaced with
Safety Specification newer version.
for Full-Size Baby
Cribs.
6-340.......... .............. ASTM F2710-13 Withdrawn.
Standard Consumer
Safety Performance
Specification for
Commercial Cribs.
6-387.......... 6-450 IEC 60601-2-50 Ed. Withdrawn and
3.0 2020-09 Medical replaced with
electrical newer version.
equipment--Part 2-
50: Particular
requirements for the
basic safety and
essential
performance of
infant phototherapy
equipment.
6-428.......... 6-451 USP 43-NF38:2020 Withdrawn and
Sodium Chloride replaced with
Irrigation. newer version.
6-429.......... 6-452 USP 43-NF38:2020 Withdrawn and
Sodium Chloride replaced with
Injection. newer version.
6-430.......... 6-453 USP 43-NF38:2020 Withdrawn and
Nonabsorbable replaced with
Surgical Suture. newer version.
6-431.......... 6-454 USP 43-NF38:2020 Withdrawn and
<881> Tensile replaced with
Strength. newer version.
6-432.......... 6-455 USP 43-NF38:2020 Withdrawn and
<861> Sutures-- replaced with
Diameter. newer version.
6-433.......... 6-456 USP 43-NF38:2020 Withdrawn and
<871> Sutures-- replaced with
Needle Attachment. newer version.
6-434.......... 6-457 USP 43-NF38:2020 Withdrawn and
Sterile Water for replaced with
Irrigation. newer version.
6-435.......... 6-458 USP 43-NF38:2020 Withdrawn and
Heparin Lock Flush replaced with
Solution. newer version.
6-436.......... 6-459 USP 43-NF38:2020 Withdrawn and
Absorbable Surgical replaced with
Suture. newer version.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-101.......... .............. CLSI H51-A Assays of Withdrawn.
von Willebrand
Factor Antigen and
Ristocetin Cofactor
Activity; Approved
Guideline.
7-112.......... 7-299 CLSI POCT14 2nd Withdrawn and
Edition Point-of- replaced with
Care Coagulation newer version.
Testing and
Anticoagulation
Monitoring.
7-131.......... .............. CLSI I/LA18-A2 Withdrawn.
(Replaces I/LA18-A)
Specifications for
Immunological
Testing for
Infectious Diseases;
Approved Guideline--
Second Edition.
7-135.......... .............. CLSI H44-A2 (Replaces Withdrawn.
H44-A) Methods for
Reticulocyte
Counting (Automated
Blood Cell Counters,
Flow Cytometry, and
Supravital Dyes);
Approved Guideline--
Second Edition.
7-142.......... .............. CLSI GP43-A4 Withdrawn.
(Formerly H11-A4)
Procedures for the
Collection of
Arterial Blood
Specimens; Approved
Standard--Fourth
Edition.
[[Page 22682]]
7-146.......... .............. CLSI M06-A2 Protocols Withdrawn.
for Evaluating
Dehydrated Mueller-
Hinton Agar;
Approved Standard--
Second Edition.
7-164.......... .............. CLSI GP28-A (Replaces Withdrawn.
GP28-P) Microwave
Device Use in the
Histology
Laboratory; Approved
Guideline.
7-173.......... .............. CLSI C44-A (Replaces Withdrawn.
C44-P) Harmonization
of Glycohemoglobin
Measurements;
Approved Guideline.
7-191.......... 7-300 CLSI MM13 2nd Edition Withdrawn and
Collection, replaced with
Transport, newer version.
Preparation, and
Storage of Specimens
for Molecular
Methods.
7-203.......... 7-301 CLSI GP42 7th Edition Withdrawn and
Collection of replaced with
Capillary Blood newer version.
Specimens.
7-211.......... 7-302 CLSI C34 4th Edition Withdrawn and
Sweat Testing: replaced with
Specimen Collection newer version.
and Quantitative
Chloride Analysis.
7-217.......... 7-303 CLSI M60 2nd Edition Withdrawn and
Performance replaced with
Standards for newer version.
Antifungal
Susceptibility
Testing of Yeast.
7-261.......... 7-304 CLSI M23 5th Edition Withdrawn and
Development of In replaced with
Vitro Susceptibility newer version.
Testing Criteria and
Quality Control
Parameters.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-217.......... 8-537 ASTM F620-20 Standard Withdrawn and
Specification for replaced with
Titanium Alloy newer version.
Forgings for
Surgical Implants in
the Alpha Plus Beta
Condition.
8-223.......... 8-538 ASTM F2759-19 Withdrawn and
Standard Guide for replaced with
Assessment of the newer version.
Ultra-High Molecular
Weight Polyethylene
(UHMWPE) Used in
Orthopedic and
Spinal Devices.
8-338.......... 8-539 ASTM F139-19 Standard Withdrawn and
Specification for replaced with
Wrought 18Chromium- newer version.
14Nickel-
2.5Molybdenum
Stainless Steel
Sheet and Strip for
Surgical Implants
(UNS S31673).
8-339.......... 8-540 ASTM F1091-20 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
20Chromium-
15Tungsten-10Nickel
Alloy Surgical
Fixation Wire (UNS
R30605).
8-342.......... 8-541 ASTM F1537-20 Withdrawn and
Standard replaced with
Specification for newer version.
Wrought Cobalt-
28Chromium-
6Molybdenum Alloys
for Surgical
Implants (UNS
R31537, UNS R31538,
and UNS R31539).
8-348.......... 8-542 ASTM F138-19 Standard Withdrawn and
Specification for replaced with
Wrought 18Chromium- newer version.
14Nickel-
2.5Molybdenum
Stainless Steel Bar
and Wire for
Surgical Implants
(UNS S31673).
8-361.......... 8-543 ASTM F755-19 Standard Withdrawn and
Specification for replaced with
Selection of Porous newer version.
Polyethylene for Use
in Surgical Implants.
8-395.......... 8-544 ASTM F961-20 Standard Withdrawn and
Specification for replaced with
35Cobalt-35Nickel- newer version.
20Chromium-
10Molybdenum Alloy
Forgings for
Surgical Implants
(UNS R30035).
8-416.......... 8-545 ASTM F2977-20 Withdrawn and
Standard Test Method replaced with
for Small Punch newer version.
Testing of Polymeric
Biomaterials Used in
Surgical Implants.
8-417.......... 8-546 ASTM F3044-20 Withdrawn and
Standard Test Method replaced with
for Evaluating the newer version.
Potential for
Galvanic Corrosion
for Medical Implants.
8-421.......... 8-547 ASTM F629-20 Standard Withdrawn and
Practice for replaced with
Radiography of Cast newer version.
Metallic Surgical
Implants.
8-438.......... 8-548 ISO/ASTM 52915 Third Withdrawn and
edition 2020-03 replaced with
Specification for newer version.
additive
manufacturing file
format (AMF) Version
1.2.
8-530.......... 8-549 ASTM F3208-20 Withdrawn and
Standard Guide for replaced with
Selecting Test Soils newer version.
for 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)
------------------------------------------------------------------------
9-40........... 9-130 ISO 8600-6: Second Withdrawn and
Edition 2020-09 replaced with
Endoscopes--Medical newer version.
endoscopes and
endotherapy devices--
Part 6: Vocabulary.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-48.......... 10-119 ISO 11979-5 Third Withdrawn and
edition 2020-09 replaced with
Ophthalmic implants-- newer version.
Intraocular Lenses--
Part 5:
Biocompatibility.
[[Page 22683]]
10-63.......... 10-120 ISO/TR 22979 Second Withdrawn and
Edition 2017-05 replaced with
Ophthalmic implants-- newer version.
Intraocular Lenses--
Guidance on
assessment of the
need for clinical
investigation of
intraocular lens
design modifications.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-191......... 11-370 ISO 14879-1 Second Withdrawn and
edition 2020-07 replaced with
Implants for newer version.
surgery--Total knee-
joint prostheses--
Part 1:
Determination of
endurance properties
of knee tibial trays.
11-267......... 11-371 ASTM F2009-20 Withdrawn and
Standard Test Method replaced with
for Determining the newer version.
Axial Disassembly
Force of Taper
Connections of
Modular Prostheses.
11-279......... 11-372 ASTM F2996-20 Withdrawn and
Standard Practice replaced with
for Finite Element newer version.
Analysis (FEA) of
Non-Modular Metallic
Orthopaedic Hip
Femoral Stems.
11-282......... 11-373 ASTM F1223-20 Withdrawn and
Standard Test Method replaced with
for Determination of newer version.
Total Knee
Replacement
Constraint.
11-313......... 11-374 ISO 7207-2 Second Withdrawn and
edition 2011-07-01 replaced with
Implants for newer version.
surgery--Components
for partial and
total knee joint
prostheses--Part 2:
Articulating
surfaces made of
metal, ceramic and
plastics materials
[Including AMENDMENT
1 (2016) and
AMENDMENT 2 (2020)].
11-330......... .............. ASTM F2028-17 Extent of
Standard Test recognition.
Methods for Dynamic
Evaluation of
Glenoid Loosening or
Disassociation.
11-332......... 11-375 ASTM F2193-20 Withdrawn and
Standard replaced with
Specifications and newer version.
Test Methods for
Components Used in
the Surgical
Fixation of the
Spinal Skeletal
System.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-314......... 14-550 ANSI/AAMI ST67:2019 Withdrawn and
Sterilization of replaced with
health care newer version.
products--Requiremen
ts and guidance for
selecting a
sterility assurance
level (SAL) for
products labeled
``sterile''.
14-361......... 14-551 ISO 14160 Third Withdrawn and
edition 2020-09 replaced with
Sterilization of newer version.
health care
products--Liquid
chemical sterilizing
agents for single-
use medical devices
utilizing animal
tissues and their
derivatives--Require
ments for
characterization,
development,
validation and
routine control of a
sterilization
process for medical
devices.
14-411......... 14-552 ISO/ASTM 51818 Fourth Withdrawn and
edition 2020-06 replaced with
Practice for newer version.
dosimetry in an
electron beam
facility for
radiation processing
at energies between
80 and 300 keV.
14-498......... 14-553 ASTM F2097-20 Withdrawn and
Standard Guide for replaced with
Design and newer version.
Evaluation of
Primary Flexible
Packaging for
Medical Products.
14-519......... 14-554 ASTM F17-20 Standard Withdrawn and
Terminology Relating replaced with
to Primary Barrier newer version.
Packaging.
14-534......... 14-555 USP 43-NF38:2020 Withdrawn and
<161> Medical replaced with
Devices-Bacterial newer version.
Endotoxin and
Pyrogen Tests.
14-535......... 14-556 USP 43-NF38:2020 <62> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Tests for Specified
Microorganisms.
14-536......... 14-557 USP 43-NF38:2020 <55> Withdrawn and
Biological replaced with
Indicators--Resistan newer version.
ce Performance Tests.
14-537......... 14-558 USP 43-NF38:2020 Withdrawn and
<1229.5> Biological replaced with
Indicators for newer version.
Sterilization.
14-546......... 14-559 USP 43-NF38:2020 <61> Withdrawn and
Microbiological replaced with
Examination of newer version.
Nonsterile Products:
Microbial
Enumeration Tests.
14-547......... 14-560 USP 43-NF38:2020 <71> Withdrawn and
Sterility Tests. replaced with
newer version.
14-548......... 14-561 USP 43-NF38:2020 <85> Withdrawn and
Bacterial Endotoxins replaced with
Test. newer version.
------------------------------------------------------------------------
[[Page 22684]]
S. Tissue Engineering
------------------------------------------------------------------------
15-35.......... .............. ASTM F2900-11 Withdrawn.
Standard Guide for
Characterization of
Hydrogels used in
Regenerative
Medicine.
15-36.......... .............. ASTM F2383-11 Withdrawn.
Standard Guide for
Assessment of
Adventitious Agents
in Tissue Engineered
Medical Products
(TEMPs).
15-38.......... .............. ASTM F2883-11 Withdrawn.
Standard Guide for
Characterization of
Ceramic and Mineral
Based Scaffolds used
for Tissue-
Engineered Medical
Products (TEMPs) and
as Device for
Surgical Implant
Applications.
15-45.......... 15-64 ISO 22442-1 Third Withdrawn and
edition 2020-09 replaced with
Medical devices newer version.
utilizing animal
tissues and their
derivatives--Part 1:
Application of risk
management.
15-46.......... 15-65 ISO 22442-2 Third Withdrawn and
edition 2020-09 replaced with
Medical devices newer version.
utilizing animal
tissues and their
derivatives--Part 2:
Controls on
sourcing, collection
and handling.
------------------------------------------------------------------------
\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: 055. 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
----------------------------------------------------------------------------------------------------------------
2-288..................... Biological evaluation of medical devices--Part 15: ISO 10993-15 Second edition
Identification and quantification of degradation 2019-11.
products from metals and alloys.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-169..................... Medical electrical equipment--Part 2-4: Particular IEC Edition 3.1 2018-02
requirements for the basic safety and essential CONSOLIDATED VERSION.
performance of cardiac defibrillators.
----------------------------------------------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-266..................... Dentistry--Orthodontic anchor screws............... ISO 19023 First edition 2018-
02.
4-267..................... Dentistry--Elastomeric auxiliaries for use in ISO 21606 First edition 2007-
orthodontics. 06.
4-268..................... Dentistry--Wires for use in orthodontics [Including ISO 15841 Second edition 2014-
AMENDMENT 1 (2020)]. 08.
4-269..................... Dentistry--Coupling dimensions for handpiece ISO 3964 Third edition 11-2016.
connectors [Including AMENDMENT 1 (2018)].
4-270..................... CAD/CAM Abutments in Dentistry..................... ADA Technical Report No. 146-
2018.
4-271..................... Dental Cartridge Syringes.......................... ANSI/ADA Standard No. 34-2013.
4-272..................... Root Canal Barbed Broaches and Rasps............... ANSI/ADA Standard No. 63-2013.
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
7-305..................... In vitro diagnostic medical devices--Requirements ISO 17511 Second edition 2020-
for establishing metrological traceability of 04.
values assigned to calibrators, trueness control
materials and human samples..
----------------------------------------------------------------------------------------------------------------
[[Page 22685]]
I. Materials
----------------------------------------------------------------------------------------------------------------
8-550..................... Standard Specification for Wrought Seamless ASTM F2181-20.
Stainless Steel Tubing for Surgical Implants.
8-551..................... Standard Practice for Digital Radiography of Cast ASTM F2895-20.
Metallic Implants.
8-552..................... Guide for Additive manufacturing--Installation/ ASTM F3434-20.
Operation and Performance Qualification (IQ/OQ/PQ)
of Laser-Beam Powder Bed Fusion Equipment for
Production Manufacturing New publication.
8-553..................... Additive manufacturing--Material extrusion-based ISO/ASTM 52903-1 First edition
additive manufacturing of plastic materials--Part 2020-04.
1: Feedstock materials.
8-554..................... Additive manufacturing--Design--Functionally graded ISO/ASTM TR 52912 First edition
additive manufacturing. 2020-09.
----------------------------------------------------------------------------------------------------------------
J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-17..................... Nanotechnologies--Measurements of particle size and ISO 21363 First edition 2020-
shape distributions by transmission electron 06.
microscopy.
18-18..................... Standard Test Method for Measuring the Size of ASTM E3247-20.
Nanoparticles in Aqueous Media Using Dynamic Light
Scattering.
----------------------------------------------------------------------------------------------------------------
K. Neurology
----------------------------------------------------------------------------------------------------------------
17-17..................... Standard Specification for Neurosurgical Head ASTM F3395/F3395M-19.
Holder Devices.
----------------------------------------------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-121.................... Ophthalmic implants--Ocular endotamponades......... ISO 16672 Third edition 2020-
06.
----------------------------------------------------------------------------------------------------------------
N. Orthopedic
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-230.................... American National Standard for Wheelchairs--Volume ANSI/RESNA WC-2:2019 Section
2: Additional Requirements for Wheelchairs 25.
(including Scooters) with Electrical Systems
Section 25: Batteries and Chargers for Powered
Wheelchairs.
----------------------------------------------------------------------------------------------------------------
P. Radiology
----------------------------------------------------------------------------------------------------------------
No new entries at this time.
----------------------------------------------------------------------------------------------------------------
Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-116.................... Common Vulnerability Scoring System version 3.0.... FIRST CVSS v3.0.
----------------------------------------------------------------------------------------------------------------
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
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
[[Page 22686]]
recommendation, to [email protected]. To be considered,
such recommendations should contain, at a minimum, the information
available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.
Dated: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08992 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P
