Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060, 52173-52179 [2023-16770]
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Notices
addition, ORR has written an
instructional letter for the Mental Health
Assessment Form to explain the
purpose of the form and provide general
guidance on completion to healthcare
providers.
Respondents: Mental health
professionals (psychiatrists, psychiatric
nurse practitioners or physician’s
assistants, licensed psychologist or any
other community based licensed mental
health provider (e.g., social worker)),
care provider program staff.
Annual Burden Estimates
ESTIMATED OPPORTUNITY TIME FOR RESPONDENTS
Annual
number of
respondents
Instrument
Respondent
Mental Health Assessment Form .....
Public Health Investigation Form:
Active TB.
Public Health Investigation Form:
Non-TB Illness.
Mental health professionals .............
Care provider program staff .............
Total
number of
responses per
respondent
500
500
500
6.8
1
200
Average
burden hours
per response
0.18
0.08
0.08
Annual
burden
hours
612
400
8,000
Estimated Total Annual Burden
Hours: 9,012.
ESTIMATED RECORDKEEPING TIME
Respondent
Mental Health Assessment Form .....
Public Health Investigation Form:
Active TB
Public Health Investigation Form:
Non-TB Illness
Care provider program staff .............
Estimated Total Annual Burden
Hours: 9,114.
Authority: 6 U.S.C. 279: Exhibit 1,
part A.2 of the Flores Settlement
Agreement (Jenny Lisette Flores, et al.,
v. Janet Reno, Attorney General of the
United States, et al., Case No. CV 85–
4544–RJK [C.D. Cal. 1996])
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2023–16840 Filed 8–4–23; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
ddrumheller on DSK120RN23PROD with NOTICES1
Annual
number of
respondents
Instrument
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
060
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
SUMMARY:
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Total
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
500
500
6.8
1
0.21
0.08
714
400
500
200
0.08
8,000
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: 060’’
(Recognition List Number: 060), 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
August 7, 2023.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
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’’).
Electronic 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
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
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Written/Paper Submissions
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Notices
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: 060.’’ 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: 060.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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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: 060 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: 060
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: 060’’ to
Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring,
MD 20993, 301–796–6580. 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:
Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring,
MD 20993, 301–796–6580,
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 of the
FD&C Act 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/
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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 HTML
and PDF versions of the list of FDA
Recognized Consensus Standards,
available at https://www.fda.gov/
medical-devices/standards-andconformity-assessment-program/federalregister-documents. Additional
information on the Agency’s Standards
and Conformity Assessment Program is
available at https://www.fda.gov/
medical-devices/device-advicecomprehensive-regulatory-assistance/
standards-and-conformity-assessmentprogram.
II. Modifications to the List of
Recognized Standards, Recognition List
Number: 060
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: 060’’ 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: 060.
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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
1–127 ..........
1–161
ISO 16628 Second edition 2022–06 Anaesthetic and respiratory equipment—Tracheobronchial tubes.
Withdrawn and replaced with newer
version.
B. Biocompatibility
2–213 ..........
2–299
2–222 ..........
2–300
2–227 ..........
2–301
ASTM F1904–23 Standard Guide for Testing the Biological Responses to
Medical Device Particulate Debris and Degradation Products in vivo.
ISO 10993–2 Third edition 2022–11 Biological evaluation of medical devices—Part 2: Animal welfare requirements.
ASTM F1983–23 Standard Practice for Assessment of Selected Tissue
Effects of Absorbable Biomaterials for Implant Applications.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
C. Cardiovascular
3–87 ............
3–184
ASTM F2477–23 Standard Test Methods for in vitro Pulsatile Durability
Testing of Vascular Stents and Endovascular Prostheses.
Withdrawn and replaced with newer
version.
D. Dental/Ear, Nose, and Throat (ENT)
4–86 ............
......................
4–139 ..........
4–181 ..........
......................
4–298
4–198 ..........
4–299
4–227 ..........
4–300
4–231 ..........
......................
4–240 ..........
4–301
4–248 ..........
4–302
4–249 ..........
4–253 ..........
4–264 ..........
......................
......................
4–303
4–267 ..........
4–304
ANSI/ADA Standard No. 38–2000 (R2015) Metal-Ceramic Dental Restorative Systems.
ANSI/ADA Standard No. 48–2004 (R2015) Visible Light Curing Units .......
ISO 4049 Fifth edition 2019–05 Dentistry—Polymer-based restorative materials.
ISO 3107 Fifth edition 2022–09 Dentistry—Zinc oxide-eugenol cements
and non-eugenol zinc oxide cements.
ISO 22674 Third edition 2022–08 Dentistry—Metallic materials for fixed
and removable restorations and appliances.
ISO/TS 11405 Third edition 2015–02–01 Dentistry—Testing of adhesion
to tooth structure.
ISO 21563 Second edition 2021–08 Dentistry—Hydrocolloid impression
materials.
ISO 10477 Fourth edition 2020–10 Dentistry—Polymer-based crown and
veneering materials.
ANSI/ADA Standard No. 19–2018 Elastometric Impression Materials ........
ANSI/ADA Standard No. 27–2016 Polymer-based Restorative Materials ...
ISO 9333 Third edition 2022–08 Dentistry—Brazing materials ...................
ISO 21606 Second edition 2022–08 Dentistry—Elastomeric auxiliaries for
use in orthodontics.
Withdrawn.
Withdrawn.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn.
Withdrawn and replaced
version.
Withdrawn and replaced
version.
Withdrawn.
Withdrawn. See 4–298.
Withdrawn and replaced
version.
Withdrawn and replaced
version.
with newer
with newer
with newer
with newer
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–34 ..........
......................
IEC 61010–1 Edition 3.1 2017–01 CONSOLIDATED VERSION Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements [Including: Corrigendum 1
(2019)].
Recognition restored.
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G. General Hospital/General Plastic Surgery (GH/GPS)
6–253 ..........
6–486
6–296 ..........
6–487
6–306 ..........
6–488
6–321 ..........
6–489
6–357 ..........
6–490
6–402 ..........
6–491
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ISO 10535 Third Edition 2021–10 Assistive products—Hoists for the
transfer of persons—Requirements and test methods.
AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
ASTM F1671/F1671M–22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.
IEC 60601–2–52 Edition 1.1 2015–03 CONSOLIDATED VERSION Medical electrical equipment—Part 2–52: Particular requirements for the
basic safety and essential performance of medical beds.
ISO 10555–6 First edition 2015–04–15 Intravascular catheters—Sterile
and single-use catheters—Part 6: Subcutaneous implanted ports [Including Amendment 1 (2019)].
ASTM F1670/F1670M–17a Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood.
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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.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
6–425 ..........
6–492
6–427 ..........
6–493
6–474 ..........
6–494
Title of standard 1
Change
ASTM F2100–23 Standard Specification for Performance of Materials
Used in Medical Face Masks.
ASTM F2101–23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus.
ASTM F3352/F3352M–23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
H. In Vitro Diagnostics (IVD)
7–152 ..........
7–315
7–244 ..........
7–316
7–308 ..........
7–317
CLSI EP12 3rd Edition Evaluation of Qualitative, Binary Output Examination Performance.
CLSI NBS01 7th Edition Dried Blood Spot Specimen Collection for Newborn Screening.
CLSI M100, 33rd Edition Performance Standards for Antimicrobial Susceptibility Testing.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
I. Materials
8–200 ..........
8–597
8–441 ..........
8–598
8–453 ..........
8–599
8–467 ..........
8–600
8–506 ..........
8–601
8–528 ..........
8–602
8–555 ..........
8–603
ASTM F2003–02(2022) Standard Practice for Accelerated Aging of UltraHigh Molecular Weight Polyethylene After Gamma Irradiation in Air.
ASTM F3109–22 Standard Practice for Verification of Multi-Axis Force
Measuring Platforms.
ASTM F1295–22 Standard Specification for Wrought Titanium6Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS
R56700).
ASTM F1978–22 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser.
ASTM F2516–22 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials.
ASTM F2503–23 Standard Practice for Marking Medical Devices and
Other Items for Safety in the Magnetic Resonance Environment.
ASTM F1472–23 Standard Specification for Wrought Titanium6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS
R56400).
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.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
J. Nanotechnology
18–15 ..........
18–23
ASTM E3025–22 Standard Guide for Tiered Approach to Detection and
Characterization of Silver Nanomaterials in Textiles.
Withdrawn and replaced with newer
version.
K. Neurology
No new entries at this time.
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L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
9–67 ............
9–145
9–94 ............
9–146
9–125 ..........
9–147
9–128 ..........
9–148
9–143 ..........
......................
ASTM D7661–18 Standard Test Method for Determining Compatibility of
Personal Lubricants with Natural Rubber Latex Condoms.
ISO 8600–4 Third Edition 2023–01 Endoscopes—Medical endoscopes
and endotherapy devices—Part 4: Determination of maximum width of
insertion portion.
ISO/CIE 11664–2 First edition 2022–08 Colorimetry—Part 2: CIE standard illuminants.
ISO/CIE 11664–6 Second edition 2022–08 Colorimetry—Part 6:
CIEDE2000 Colour-difference formula.
ISO 20696 First edition 2018–06 Corrected version 2019–12 Sterile
urethral catheters for single use.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Extent of recognition.
M. Ophthalmic
No new entries at this time.
N. Orthopedic
11–294 ........
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18:58 Aug 04, 2023
ASTM F1357–23 Standard Specification for Articulating Total Wrist Implants.
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version.
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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
O. Physical Medicine
16–165 ........
16–234
16–194 ........
16–235
16–201 ........
16–236
ISO 7176–14 Third Edition 2022 Wheelchairs—Part 14 Power and control
systems for electrically powered wheelchairs and scooters—Requirements and test methods.
ISO 7176–25 Second Edition 2022 Wheelchairs—Part 25: Lead-acid batteries and chargers for powered wheelchairs—Requirements and test
methods.
ISO 7176–19 Third Edition 2022 Wheelchairs—Part 19: Wheeled mobility
devices for use as seats in motor vehicles.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
P. Radiology
12–6 ............
12–350
12–347 ........
......................
12–329 ........
12–351
IEC 60806 Edition 2.0 2022–11 Determination of the maximum symmetrical radiation field of X-ray tube assemblies and X-ray source assemblies for medical diagnosis.
IEC 60601–2–33 Edition 4.0 2022–08 Medical electrical equipment—Part
2–33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.
IEC 60601–2–43 Edition 3.0 2022–12 Medical electrical equipment—Part
2–43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures.
Withdrawn and replaced with newer
version.
Transition period extended.
Withdrawn and replaced with newer
version.
Q. Software/Informatics
No new entries at this time.
R. Sterility
14–169 ........
14–584
14–456 ........
14–585
14–575 ........
......................
ASTM F2391–22 Standard Test Method for Measuring Package and Seal
Integrity Using Helium as the Tracer Gas.
ISO/TS 16775 Second edition 2021–11 Packaging for terminally sterilized
medical devices—Guidance on the application of ISO 11607–1 and ISO
11607–2.
ASTM F1980–21 Standard Guide for Accelerated Aging of Sterile Barrier
Systems for Medical Devices.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Transition period extended.
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.
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: 060. 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
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No new entries at this time.
C. Cardiovascular
3–185 .........
3–186 .........
3–187 .........
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Active implantable medical devices—Requirements and test protocols for safety of
patients with pacemakers and ICDs exposed to magnetic resonance imaging.
Implants for surgery—Active implantable medical devices—Part 2: Cardiac pacemakers.
Implants for surgery—Active implantable medical devices—Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators).
18:58 Aug 04, 2023
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ANSI/AAMI PC76:2021.
ISO 14708–2 Third edition 2019–09.
ISO 14708–6 Second edition 2019–09.
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TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition
No.
Title of standard 1
3–188 .........
Non-invasive sphygmomanometers—Part 3: Clinical investigation of continuous automated measurement type.
Reference No. and date
ISO 81060–3 First edition 2022–12.
D. Dental/ENT
4–305 .........
4–306 .........
4–307 .........
4–308 .........
Dentistry—Central suction source equipment ................................................................
Dentistry—Compressed air source equipment ...............................................................
Dentistry—General requirements for instruments and related accessories used in
dental implant placement and treatment.
Implants for surgery—Active implantable medical devices—Part 7: Particular requirements for cochlear and auditory brainstem implant systems.
ISO 10637 Second edition 2018–05.
ISO 22052 First edition 2020–06.
ISO 13504 First edition 2012–07.
ISO 14708–7 Second edition 2019–12
(Corrected version 2020–05).
E. General I (QS/RM)
No new entries at this time.
F. General II (ES/EMC)
19–49 .........
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance.
IEC 60601–1 Edition 3.2 2020–08 CONSOLIDATED VERSION.
G. GH/GPS
6–495 .........
6–496 .........
Catheter systems for neuraxial application—Sterile and single-use catheters and accessories.
Standard Test Method for Permeation of Liquids and Gases Through Protective
Clothing Materials Under Conditions of Continuous Contact.
ISO 20698 First Edition 2018–07.
ASTM F739–20.
H. IVD
No new entries at this time.
I. Materials
8–604 .........
Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673).
ASTM F2257–22.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. OB-Gyn/G/Urology
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9–149 .........
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Medical electrical equipment—Part 2–39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment.
18:58 Aug 04, 2023
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IEC 60601–2–39 Edition 3.0 2018–04.
E:\FR\FM\07AUN1.SGM
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Federal Register / Vol. 88, No. 150 / Monday, August 7, 2023 / Notices
52179
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition
No.
Title of standard 1
Reference No. and date
M. Ophthalmic
No new entries at this time.
N. Orthopedic
No new entries at this time.
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
14–586 .......
14–587 .......
14–588 .......
Sterilization of health care products—Low temperature vaporized hydrogen peroxide—Requirements for the development, validation and routine control of a sterilization process for medical devices.
Guidance on transferring health care products between radiation sterilization sources
Compatibility of materials subjected to sterilization ........................................................
ISO 22441 First edition 2022–08.
AAMI TIR104:2022.
AAMI TIR17:2017/(R)2020.
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.
ddrumheller on DSK120RN23PROD with NOTICES1
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/device-
VerDate Sep<11>2014
18:58 Aug 04, 2023
Jkt 259001
advice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Dated: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–16770 Filed 8–4–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3032]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; Bromazolam;
Flubromazepam; Butonitazene; 3Chloromethcathinone (3-CMC);
Dipentylone; 2Fluorodeschloroketamine (2-FDCK);
Nitrous Oxide (N2O); Carisoprodol;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00072
Fmt 4703
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inviting interested persons to submit
comments concerning abuse potential,
actual abuse, medical usefulness,
trafficking, and impact of scheduling
changes on availability for medical use
of eight drug substances. These
comments will be considered in
preparing a response from the United
States to the World Health Organization
(WHO) regarding the abuse liability and
diversion of these drugs. WHO will use
this information to consider whether to
recommend that certain international
restrictions be placed on these drug
substances. This notice requesting
comments is required by the Controlled
Substances Act (CSA).
Either electronic or written
comments must be submitted by August
24, 2023.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
August 24, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ADDRESSES:
E:\FR\FM\07AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Notices]
[Pages 52173-52179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16770]
-----------------------------------------------------------------------
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: 060
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: 060'' (Recognition List Number: 060), 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 August 7, 2023.
ADDRESSES: You may submit comments on the current list of FDA
Recognized Consensus Standards at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for
[[Page 52174]]
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: 060.'' 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: 060.
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: 060 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:
060 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: 060'' to Jianchao Zeng, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580. 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: Jianchao Zeng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301-796-6580,
[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
of the FD&C Act 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 HTML and 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: 060
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: 060'' 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: 060.
[[Page 52175]]
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-127........... 1-161 ISO 16628 Second Withdrawn and
edition 2022-06 replaced with
Anaesthetic and newer version.
respiratory
equipment--Tracheobro
nchial tubes.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-213........... 2-299 ASTM F1904-23 Standard Withdrawn and
Guide for Testing the replaced with
Biological Responses newer version.
to Medical Device
Particulate Debris
and Degradation
Products in vivo.
2-222........... 2-300 ISO 10993-2 Third Withdrawn and
edition 2022-11 replaced with
Biological evaluation newer version.
of medical devices--
Part 2: Animal
welfare requirements.
2-227........... 2-301 ASTM F1983-23 Standard Withdrawn and
Practice for replaced with
Assessment of newer version.
Selected Tissue
Effects of Absorbable
Biomaterials for
Implant Applications.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-87............ 3-184 ASTM F2477-23 Standard Withdrawn and
Test Methods for in replaced with
vitro Pulsatile newer version.
Durability Testing of
Vascular Stents and
Endovascular
Prostheses.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-86............ ............ ANSI/ADA Standard No. Withdrawn.
38-2000 (R2015) Metal-
Ceramic Dental
Restorative Systems.
4-139........... ............ ANSI/ADA Standard No. Withdrawn.
48-2004 (R2015)
Visible Light Curing
Units.
4-181........... 4-298 ISO 4049 Fifth edition Withdrawn and
2019-05 Dentistry-- replaced with
Polymer-based newer version.
restorative materials.
4-198........... 4-299 ISO 3107 Fifth edition Withdrawn and
2022-09 Dentistry-- replaced with
Zinc oxide-eugenol newer version.
cements and non-
eugenol zinc oxide
cements.
4-227........... 4-300 ISO 22674 Third Withdrawn and
edition 2022-08 replaced with
Dentistry--Metallic newer version.
materials for fixed
and removable
restorations and
appliances.
4-231........... ............ ISO/TS 11405 Third Withdrawn.
edition 2015-02-01
Dentistry--Testing of
adhesion to tooth
structure.
4-240........... 4-301 ISO 21563 Second Withdrawn and
edition 2021-08 replaced with
Dentistry--Hydrocollo newer version.
id impression
materials.
4-248........... 4-302 ISO 10477 Fourth Withdrawn and
edition 2020-10 replaced with
Dentistry--Polymer- newer version.
based crown and
veneering materials.
4-249........... ............ ANSI/ADA Standard No. Withdrawn.
19-2018 Elastometric
Impression Materials.
4-253........... ............ ANSI/ADA Standard No. Withdrawn. See 4-
27-2016 Polymer-based 298.
Restorative Materials.
4-264........... 4-303 ISO 9333 Third edition Withdrawn and
2022-08 Dentistry-- replaced with
Brazing materials. newer version.
4-267........... 4-304 ISO 21606 Second Withdrawn and
edition 2022-08 replaced with
Dentistry--Elastomeri newer version.
c auxiliaries for use
in orthodontics.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-34........... ............ IEC 61010-1 Edition Recognition
3.1 2017-01 restored.
CONSOLIDATED VERSION
Safety requirements
for electrical
equipment for
measurement, control,
and laboratory use--
Part 1: General
requirements
[Including:
Corrigendum 1 (2019)].
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-253........... 6-486 ISO 10535 Third Withdrawn and
Edition 2021-10 replaced with
Assistive products-- newer version.
Hoists for the
transfer of persons--
Requirements and test
methods.
6-296........... 6-487 AAMI PB70:2022 Liquid Withdrawn and
barrier performance replaced with
and classification of newer version.
protective apparel
and drapes intended
for use in health
care facilities.
6-306........... 6-488 ASTM F1671/F1671M-22 Withdrawn and
Standard Test Method replaced with
for Resistance of newer version.
Materials Used in
Protective Clothing
to Penetration by
Blood-Borne Pathogens
Using Phi-X174
Bacteriophage
Penetration as a Test
System.
6-321........... 6-489 IEC 60601-2-52 Edition Withdrawn and
1.1 2015-03 replaced with
CONSOLIDATED VERSION newer version.
Medical electrical
equipment--Part 2-52:
Particular
requirements for the
basic safety and
essential performance
of medical beds.
6-357........... 6-490 ISO 10555-6 First Withdrawn and
edition 2015-04-15 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 6:
Subcutaneous
implanted ports
[Including Amendment
1 (2019)].
6-402........... 6-491 ASTM F1670/F1670M-17a Withdrawn and
Standard Test Method replaced with
for Resistance of newer version.
Materials Used in
Protective Clothing
to Penetration by
Synthetic Blood.
[[Page 52176]]
6-425........... 6-492 ASTM F2100-23 Standard Withdrawn and
Specification for replaced with
Performance of newer version.
Materials Used in
Medical Face Masks.
6-427........... 6-493 ASTM F2101-23 Standard Withdrawn and
Test Method for replaced with
Evaluating the newer version.
Bacterial Filtration
Efficiency (BFE) of
Medical Face Mask
Materials, Using a
Biological Aerosol of
Staphylococcus aureus.
6-474........... 6-494 ASTM F3352/F3352M-23a Withdrawn and
Standard replaced with
Specification for newer version.
Isolation Gowns
Intended for Use in
Healthcare Facilities.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-152........... 7-315 CLSI EP12 3rd Edition Withdrawn and
Evaluation of replaced with
Qualitative, Binary newer version.
Output Examination
Performance.
7-244........... 7-316 CLSI NBS01 7th Edition Withdrawn and
Dried Blood Spot replaced with
Specimen Collection newer version.
for Newborn Screening.
7-308........... 7-317 CLSI M100, 33rd Withdrawn and
Edition Performance replaced with
Standards for newer version.
Antimicrobial
Susceptibility
Testing.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-200........... 8-597 ASTM F2003-02(2022) Withdrawn and
Standard Practice for replaced with
Accelerated Aging of newer version.
Ultra-High Molecular
Weight Polyethylene
After Gamma
Irradiation in Air.
8-441........... 8-598 ASTM F3109-22 Standard Withdrawn and
Practice for replaced with
Verification of Multi- newer version.
Axis Force Measuring
Platforms.
8-453........... 8-599 ASTM F1295-22 Standard Withdrawn and
Specification for replaced with
Wrought Titanium- newer version.
6Aluminum-7Niobium
Alloy for Surgical
Implant Applications
(UNS R56700).
8-467........... 8-600 ASTM F1978-22 Standard Withdrawn and
Test Method for replaced with
Measuring Abrasion newer version.
Resistance of
Metallic Thermal
Spray Coatings by
Using the Taber
Abraser.
8-506........... 8-601 ASTM F2516-22 Standard Withdrawn and
Test Method for replaced with
Tension Testing of newer version.
Nickel-Titanium
Superelastic
Materials.
8-528........... 8-602 ASTM F2503-23 Standard Withdrawn and
Practice for Marking replaced with
Medical Devices and newer version.
Other Items for
Safety in the
Magnetic Resonance
Environment.
8-555........... 8-603 ASTM F1472-23 Standard Withdrawn and
Specification for replaced with
Wrought Titanium- newer version.
6Aluminum-4Vanadium
Alloy for Surgical
Implant Applications
(UNS R56400).
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-15........... 18-23 ASTM E3025-22 Standard Withdrawn and
Guide for Tiered replaced with
Approach to Detection newer version.
and Characterization
of Silver
Nanomaterials in
Textiles.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
9-67............ 9-145 ASTM D7661-18 Standard Withdrawn and
Test Method for replaced with
Determining newer version.
Compatibility of
Personal Lubricants
with Natural Rubber
Latex Condoms.
9-94............ 9-146 ISO 8600-4 Third Withdrawn and
Edition 2023-01 replaced with
Endoscopes--Medical newer version.
endoscopes and
endotherapy devices--
Part 4: Determination
of maximum width of
insertion portion.
9-125........... 9-147 ISO/CIE 11664-2 First Withdrawn and
edition 2022-08 replaced with
Colorimetry--Part 2: newer version.
CIE standard
illuminants.
9-128........... 9-148 ISO/CIE 11664-6 Second Withdrawn and
edition 2022-08 replaced with
Colorimetry--Part 6: newer version.
CIEDE2000 Colour-
difference formula.
9-143........... ............ ISO 20696 First Extent of
edition 2018-06 recognition.
Corrected version
2019-12 Sterile
urethral catheters
for single use.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-294.......... 11-399 ASTM F1357-23 Standard Withdrawn and
Specification for replaced with
Articulating Total newer version.
Wrist Implants.
------------------------------------------------------------------------
[[Page 52177]]
O. Physical Medicine
------------------------------------------------------------------------
16-165.......... 16-234 ISO 7176-14 Third Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 14 newer version.
Power and control
systems for
electrically powered
wheelchairs and
scooters--Requirement
s and test methods.
16-194.......... 16-235 ISO 7176-25 Second Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 25: newer version.
Lead-acid batteries
and chargers for
powered wheelchairs--
Requirements and test
methods.
16-201.......... 16-236 ISO 7176-19 Third Withdrawn and
Edition 2022 replaced with
Wheelchairs--Part 19: newer version.
Wheeled mobility
devices for use as
seats in motor
vehicles.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-6............ 12-350 IEC 60806 Edition 2.0 Withdrawn and
2022-11 Determination replaced with
of the maximum newer version.
symmetrical radiation
field of X-ray tube
assemblies and X-ray
source assemblies for
medical diagnosis.
12-347.......... ............ IEC 60601-2-33 Edition Transition
4.0 2022-08 Medical period
electrical equipment-- extended.
Part 2-33: Particular
requirements for the
basic safety and
essential performance
of magnetic resonance
equipment for medical
diagnosis.
12-329.......... 12-351 IEC 60601-2-43 Edition Withdrawn and
3.0 2022-12 Medical replaced with
electrical equipment-- newer version.
Part 2-43: Particular
requirements for the
basic safety and
essential performance
of X-ray equipment
for interventional
procedures.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-169.......... 14-584 ASTM F2391-22 Standard Withdrawn and
Test Method for replaced with
Measuring Package and newer version.
Seal Integrity Using
Helium as the Tracer
Gas.
14-456.......... 14-585 ISO/TS 16775 Second Withdrawn and
edition 2021-11 replaced with
Packaging for newer version.
terminally sterilized
medical devices--
Guidance on the
application of ISO
11607-1 and ISO 11607-
2.
14-575.......... ............ ASTM F1980-21 Standard Transition
Guide for Accelerated period
Aging of Sterile extended.
Barrier Systems for
Medical Devices.
------------------------------------------------------------------------
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.
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: 060. These entries are of standards not
previously recognized by FDA.
Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No. and
Recognition No. Title of standard \1\ date
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-185................ Active implantable medical ANSI/AAMI PC76:2021.
devices--Requirements and
test protocols for safety
of patients with
pacemakers and ICDs
exposed to magnetic
resonance imaging.
3-186................ Implants for surgery-- ISO 14708-2 Third
Active implantable edition 2019-09.
medical devices--Part 2:
Cardiac pacemakers.
3-187................ Implants for surgery-- ISO 14708-6 Second
Active implantable edition 2019-09.
medical devices--Part 6:
Particular requirements
for active implantable
medical devices intended
to treat tachyarrhythmia
(including implantable
defibrillators).
[[Page 52178]]
3-188................ Non-invasive ISO 81060-3 First
sphygmomanometers--Part edition 2022-12.
3: Clinical investigation
of continuous automated
measurement type.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-305................ Dentistry--Central suction ISO 10637 Second
source equipment. edition 2018-05.
4-306................ Dentistry--Compressed air ISO 22052 First
source equipment. edition 2020-06.
4-307................ Dentistry--General ISO 13504 First
requirements for edition 2012-07.
instruments and related
accessories used in
dental implant placement
and treatment.
4-308................ Implants for surgery-- ISO 14708-7 Second
Active implantable edition 2019-12
medical devices--Part 7: (Corrected version
Particular requirements 2020-05).
for cochlear and auditory
brainstem implant systems.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
19-49................ Medical electrical IEC 60601-1 Edition
equipment--Part 1: 3.2 2020-08
General requirements for CONSOLIDATED
basic safety and VERSION.
essential performance.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
6-495................ Catheter systems for ISO 20698 First
neuraxial application-- Edition 2018-07.
Sterile and single-use
catheters and accessories.
6-496................ Standard Test Method for ASTM F739-20.
Permeation of Liquids and
Gases Through Protective
Clothing Materials Under
Conditions of Continuous
Contact.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-604................ Standard Specification for ASTM F2257-22.
Wrought Seamless or
Welded and Drawn
18Chromium-14Nickel-
2.5Molybdenum Stainless
Steel Small Diameter
Tubing for Surgical
Implants (UNS S31673).
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-149................ Medical electrical IEC 60601-2-39
equipment--Part 2-39: Edition 3.0 2018-04.
Particular requirements
for basic safety and
essential performance of
peritoneal dialysis
equipment.
------------------------------------------------------------------------
[[Page 52179]]
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
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No new entries at this time.
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Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-586............... Sterilization of health ISO 22441 First
care products--Low edition 2022-08.
temperature vaporized
hydrogen peroxide--
Requirements for the
development, validation
and routine control of a
sterilization process for
medical devices.
14-587............... Guidance on transferring AAMI TIR104:2022.
health care products
between radiation
sterilization sources.
14-588............... Compatibility of materials AAMI TIR17:2017/
subjected to (R)2020.
sterilization.
------------------------------------------------------------------------
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: August 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16770 Filed 8-4-23; 8:45 am]
BILLING CODE 4164-01-P
