Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061, 15202-15208 [2024-04376]
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Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices
for Public Comments’’ or by using the
search function.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision with change of a
currently approved collection; Title of
Information Collection: Collection of
Prescription Drug Data from MA–PD,
PDP and Fallout Plans/Sponsors for
Medicare Part D Payments; Use: The
PDE data is used in the Payment
Reconciliation System to perform the
annual Part D payment reconciliation,
any PDE data within the Coverage Gap
Phase of the Part D benefit is used for
invoicing in the CGDP, and the data are
part of the report provided to the
Secretary of the Treasury for Section
9008.
Sections 11001 through 11004 of the
Inflation Reduction Act of 2022
establish a Medicare Drug Negotiation
Program for high-expenditure drugs.
Section 11102 of the Inflation Reduction
Act of 2022 establishes a Part D inflation
rebate by manufacturers of certain single
source drugs and biologicals with prices
increasing at a rate faster than the rate
of inflation. CMS will use data reported
under sections 1860D–15(c)(1)(C) and
(d)(2), in part, to rank drugs by total
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expenditures under Part D in order to
select drugs for negotiation and to
identify units to calculate inflation
rebates.
The information users will be
pharmacy benefit managers (PBMs),
third party administrators and
pharmacies, and the PDPs, MA–PDs,
Fallbacks, and other plans that offer
coverage of outpatient prescription
drugs under the Medicare Part D benefit
to Medicare beneficiaries. The
statutorily required data is used
primarily for payment and is used for
claim validation as well as for other
legislated functions such as quality
monitoring, program integrity and
oversight. In addition, the PDE data are
used to support operations and program
development. Form Number: CMS–
10174 (OMB control number: 0938–
0982); Frequency: Monthly; Affected
Public: Private sector and Federal
Government; Number of Respondents:
856; Total Annual Responses:
1,499,064,780; Total Annual Hours:
62,918. (For policy questions regarding
this collection contact Shelly Winston at
410–786–3694.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Indirect
Medical Education and Direct Graduate
Medical Education; Use: Section
1886(d)(5)(B) of the Social Security Act
requires additional payments to be
made under the Medicare Prospective
Payment System (PPS) for the indirect
medical educational costs a hospital
incurs in connection with interns and
residents (IRs) in approved teaching
programs. In addition, title 42, part 413,
sections 75 through 83 implement
section 1886(d) of the Act by
establishing the methodology for
Medicare payment for the costs of direct
graduate medical educational activities.
The information collected on IRs is
used by Part- A Medicare
Administrative Contractors (MAC) to
verify the number of IRs FTE used in the
calculation of Medicare payments for
IME and GME. The IR data submitted by
the hospitals to the MACs is uploaded
into CMS’ Intern and Resident
Information System (IRIS) database to
identify duplicate FTEs reported for any
IR.
The MACs use the information
collected on IRs to ensure that all
program payments for IME and GME are
accurate and are in accordance with
Medicare regulations. The IR data
submitted by the hospitals to the MACs
are used to audit the Medicare cost
reports filed by the hospitals. Form
Number: CMS–R–64 (OMB control
number: 0938–0456); Frequency:
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Monthly; Affected Public: Private sector
and Federal Government; Number of
Respondents: 1,245; Total Annual
Responses: 1,245; Total Annual Hours:
2,490. (For policy questions regarding
this collection contact Owen Osaghae at
410–786–7550.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–04341 Filed 2–29–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
061
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: 061’’
(Recognition List Number: 061), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
March 1, 2024.
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
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Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 061.’’ 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: 061.
• 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
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
An electronic copy of Recognition List
Number: 061 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: 061
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: 061’’ to Terry
Woods, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993,
301–796–2503. 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:
Terry Woods, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993,
301–796–2503, 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
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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-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: 061
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: 061’’ 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
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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: 061.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
A. Anesthesiology
1–73 ............
1–162
1–105 ..........
1–163
1–118 ..........
1–164
1–141 ..........
1–165
ISO 10651–4 Second edition 2023–03 Lung ventilators—Part 4: Particular
requirements for user-powered resuscitators.
ISO 80601–2–72 Second edition 2023–06 Medical electrical equipment—
Part 2–72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients.
ISO 5361 Fourth edition 2023–11 Anaesthetic and respiratory equipment—Tracheal tubes and connectors.
ISO 80601–2–13 Second edition 2022–04 Medical electrical equipment—
Part 2–13: Particular requirements for basic safety and essential performance of an anaesthetic workstation.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
B. Biocompatibility
2–94 ............
2–302
2–237 ..........
2–303
ASTM F981–23 Standard Practice for Assessment of Muscle and Bone
Tissue Responses to Long-Term Implantable Materials Used in Medical
Devices.
ISO 10993–17 Second edition 2023–09 Biological evaluation of medical
devices—Part 17: Toxicological risk assessment of medical device constituents.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
C. Cardiovascular
3–105 ..........
......................
3–126 ..........
......................
3–138 ..........
3–189
IEC 60601–2–25 Edition 2.0 2011–10 Medical electrical equipment—Part
2–25: Particular requirements for the basic safety and essential performance of electrocardiographs.
IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment—Part
2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)].
ASTM F2942–19 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents.
Extent of recognition.
Extent of recognition.
Withdrawn and replaced with newer
version.
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D. Dental/Ear, Nose, and Throat (ENT)
4–137 ..........
4–309
4–151 ..........
4–310
4–188 ..........
4–311
4–190 ..........
4–312
4–218 ..........
4–313
4–221 ..........
4–314
4–224 ..........
4–315
4–238 ..........
4–316
4–244 ..........
4–317
4–246 ..........
4–318
4–257 ..........
4–319
ISO 20127 Second edition 2020–08 Dentistry—Physical properties of
powered toothbrushes.
ISO 8325 Third edition 2023–03 Dentistry—Test methods for rotary instruments.
ISO 20749 Second edition 2023–06 Dentistry—Pre-capsulated dental
amalgam.
ISO 17730 Second edition 2020–09 Dentistry—Fluoride varnishes ............
4–280 ..........
......................
ANSI/ADA Standard No. 117–2018 Fluoride varnishes ...............................
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ISO 6877 Third edition 2021–09 Dentistry—Endodontic obturating materials.
ISO 22112 Second edition 2017–08 Dentistry—Artificial teeth for dental
prostheses.
ISO 9917–2 Third edition 2017–09 Dentistry—Water-based cements—
Part 2: Resin-modified cements.
ANSI/ASA S3.35–2021 American National Standard Method for Method of
Measurement of Performance Characteristics of Hearing Aids Under
Simulated Real-Ear Working Conditions.
ISO 27020 Second edition 2019–06 Dentistry—Brackets and tubes for
use in orthodontics.
ISO 7494–2 Third edition 2022–07 Dentistry—Stationary dental units and
dental patient chairs—Part 2: Air, water, suction and wastewater systems.
ISO 24234 Third edition 2021–08 Dentistry—Dental Amalgam ...................
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Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
319.
01MRN1
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
with transition. See 4–
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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
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
No new entries at this time.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–338 ..........
6–497
ASTM D7866–23 Standard Specification for Radiation Attenuating Protective Gloves.
Withdrawn and replaced with newer
version.
H. In Vitro Diagnostics (IVD)
7–235 ..........
7–318
7–304 ..........
7–319
CLSI EP25 2nd Edition Evaluation of Stability of In Vitro Medical Laboratory Test Reagents.
CLSI M23 6th Edition Development of In Vitro Susceptibility Test Methods, Breakpoints, and Quality Control Parameters.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
I. Materials
8–171 ..........
8–605
8–412 ..........
8–606
8–437 ..........
8–607
8–451 ..........
8–608
8–475 ..........
8–609
8–483 ..........
8–610
ASTM F1609–23 Standard Specification for Calcium Phosphate Coatings
for Implantable Materials.
ASTM F2537–23 Standard Practice for Calibration of Linear Displacement
Sensor Systems Used to Measure Micromotion.
ASTM F2082/F2082M–23 Determination of Transformation Temperature
of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery.
ASTM F2214–2023 Standard Test Method for In Situ Determination of
Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE).
ASTM F2026–23 Standard Specification for Polyetheretherketone (PEEK)
Polymers for Surgical Implant Applications.
ASTM F601–23 Standard Practice for Fluorescent Penetrant Inspection of
Metallic Surgical Implants.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
and replaced with newer
and replaced with newer
and replaced with newer
and replaced with newer
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
J. Nanotechnology
No new entries at this time.
K. Neurology
No new entries at this time.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
No new entries at this time.
ddrumheller on DSK120RN23PROD with NOTICES1
N. Orthopedic
11–83 ..........
......................
11–276 ........
11–402
11–281 ........
......................
11–299 ........
......................
11–301 ........
......................
11–303 ........
11–403
11–321 ........
11–404
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ISO 13402 First edition 1995–08–01 Surgical and dental hand instruments—Determination of resistance against autoclaving, corrosion and
thermal exposure.
ASTM F1798–21 Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies
Used in Spinal Arthrodesis Implants.
ASTM F1672–14 (Reapproved 2019) Standard Specification for Resurfacing Patellar Prosthesis.
ASTM F2068–15 Standard Specification for Femoral Prostheses—Metallic
Implants.
ASTM F2091–15 Standard Specification for Acetabular Prostheses ..........
ASTM F3047M–23 Standard Guide for High Demand Hip Simulator Wear
Testing of Hard-on-Hard Articulations.
ASTM F2887–23 Standard Specification for Total Elbow Prostheses .........
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Transferred. See 4–320.
Withdrawn and replaced with newer
version.
Withdrawn
400.
Withdrawn
401.
Withdrawn
401.
Withdrawn
version.
Withdrawn
version.
01MRN1
with transition. See 11–
with transition. See 11–
with transition. See 11–
and replaced with newer
and replaced with newer
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
11–334 ........
11–405
11–335 ........
11–406
11–341 ........
11–407
11–377 ........
......................
Title of standard 1
Change
ASTM F1829–23 Standard Test Method for Static Evaluation of Anatomic
Glenoid Locking Mechanism in Shear.
ASTM F3141–23 Standard Guide for Total Knee Replacement Loading
Profiles.
ASTM F3140–23 Standard Test Method for Cyclic Fatigue Testing of
Metal Tibial Tray Components of Unicondylar Knee Joint Replacements.
ASTM F2083–21 Standard Specification for Knee Replacement Prosthesis.
Withdrawn
version.
Withdrawn
version.
Withdrawn
version.
Withdrawn
400.
and replaced with newer
and replaced with newer
and replaced with newer
with transition. See 11–
O. Physical Medicine
No new entries at this time.
P. Radiology
12–348 ........
......................
12–349 ........
12–352
IEC 60601–2–54 Edition 2.0 2022–09 Medical electrical equipment—Part
2–54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
NEMA PS 3.1–3.20 2023e Digital Imaging and Communications in Medicine (DICOM) set.
Extent of recognition.
Withdrawn and replaced with newer
version.
Q. Software/Informatics
No new entries at this time.
R. Sterility
14–141 ........
14–589
14–379 ........
14–590
14–390 ........
14–591
14–427 ........
14–592
14–516 ........
14–593
14–530 ........
14–594
14–531 ........
14–595
14–573 ........
14–596
ISO 14644–4 Second edition 2022–11 Cleanrooms and associated controlled environments—Part 4: Design, construction and start-up.
ISO 14644–8 Third edition 2022–06 Cleanrooms and associated controlled environments—Part 8: Assessment of air cleanliness by chemical concentration (ACC).
ISO 14644–10 Second edition 2022–05 Cleanrooms and associated controlled environments—Part 10: Assessment of surface cleanliness for
chemical contamination.
ISO 13408–1 Third edition 2023–08 Aseptic processing of health care
products—Part 1: General requirements.
ASTM F3039–23 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration.
ISO 11607–1 Second edition 2019–02 [Including ADM1:2023] Packaging
for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems [Including
Amendment 1 (2023)].
ISO 11607–2 Second edition 2019–02 [Including AMD1:2023] Packaging
for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes [Including Amendment 1 (2023)].
ASTM F88/F88M–23 Standard Test Method for Seal Strength of Flexible
Barrier Materials.
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.
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
ddrumheller on DSK120RN23PROD with NOTICES1
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: 061. These entries are of
standards not previously recognized by
FDA.
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Title of standard 1
Recognition No.
Reference No. and date
A. Anesthesiology
1–166 .................
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ISO 11195 Second edition 2018–01.
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15207
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
3–190 .................
Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840–2.
ISO/PAS 7020 First edition 2023–05.
D. Dental/ENT
4–320 .................
4–321
4–322
4–323
4–324
.................
.................
.................
.................
Surgical and dental and instruments—Determination of resistance against
autoclaving, corrosion and thermal exposure.
Dentistry—Intraoral camera .......................................................................................
Dentistry—Machinable ceramic blanks .....................................................................
Dentistry—Polymer-based composite machinable blanks ........................................
Dentistry—Polymer-based luting materials containing adhesive components .........
ISO 13402 First edition 1995–08.
ISO 23450 First edition 2021–03.
ISO 18675 First edition 2022–05.
ISO 5139 First edition 2023–05.
ISO/TS 16506 First edition 2018–03.
E. General I (QS/RM)
No new entries at this time.
F. General II (ES/EMC)
No new entries at this time.
G. GH/GPS
No new entries at this time.
H. IVD
7–320 .................
Validation of Assays Performed by Flow Cytometry .................................................
CLSI H62 1st Edition.
I. Materials
No new entries at this time.
J. Nanotechnology
18–24 .................
Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles .........
ASTM E2524–22.
K. Neurology
No new entries at this time.
L. OB-Gyn/G/Urology
9–150 .................
Copper-bearing contraceptive intrauterine devices—Requirements and tests .........
ISO 7439 Fourth edition 2023–04.
M. Ophthalmic
No new entries at this time.
N. OrthopedicX
11–400 ...............
11–401 ...............
11–408 ...............
ddrumheller on DSK120RN23PROD with NOTICES1
11–409 ...............
Non-active surgical implants—Joint replacement implants—Specific requirements
for knee-joint replacement implants.
Non-active surgical implants—Joint replacement implants—Specific requirements
for hip-joint replacement implants.
Standard Test Method for Evaluating Knee Bearing (Tibial Insert) Endurance and
Deformation Under High Flexion.
Standard Test Methods for Determining the Static Failure Load of Ceramic Knee
Femoral Components.
ISO 21536 Third edition 2023–07.
ISO 21535 Third edition 2023–07.
ASTM F2777–23.
ASTM F3495–23.
O. Physical Medicine
No new entries at this time.
P. Radiology
12–353 ...............
VerDate Sep<11>2014
American National Standard for Safe Use of Lasers ................................................
21:28 Feb 29, 2024
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ANSI Z136.1–2022.
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Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
Q. Software/Informatics
13–129 ...............
Software and systems engineering—Software testing—Part 1: General concepts
13–130 ...............
Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2–1: Particular requirements for forensic data logging.
Standard for medical device security—Security risk management for device manufacturers.
13–131 ...............
ISO/IEC/IEEE 29119–1 Second edition
2022–01.
ANSI/AAMI 2700–2–1:2022.
ANSI/AAMI SW96:2023.
R. Sterility
14–597 ...............
Water Quality for Processing Medical Devices .........................................................
ANSI/AAMI ST108:2023.
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/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Dated: February 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04376 Filed 2–29–24; 8:45 am]
BILLING CODE 4164–01–P
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21:28 Feb 29, 2024
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency guidances at any time as
follows:
Food and Drug Administration
Electronic Submissions
[Docket No. FDA–2021–D–1051]
Clinical Pharmacology Considerations
for Antibody-Drug Conjugates;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘Clinical
Pharmacology Considerations for
Antibody-Drug Conjugates,’’ which
provides recommendations for the
development of antibody-drug
conjugates (ADCs). Specifically, this
guidance addresses the FDA’s current
thinking regarding clinical
pharmacology considerations and
recommendations for ADC development
programs, including bioanalytical
methods, dose selection and adjustment,
dose- and exposure-response analysis,
intrinsic factors, QTc assessments,
immunogenicity, and drug-drug
interactions (DDIs) for ADCs with a
cytotoxic small-molecule drug or
payload. Currently, there are no final
FDA guidances outlining the clinical
pharmacology considerations for ADCs.
This guidance finalizes the draft
guidance of the same title issued on
February 8, 2022.
DATES: The announcement of the
guidance is published in the Federal
Register on March 1, 2024.
ADDRESSES: You may submit either
electronic or written comments on
SUMMARY:
PO 00000
Frm 00093
Fmt 4703
Sfmt 4703
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
E:\FR\FM\01MRN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 42 (Friday, March 1, 2024)]
[Notices]
[Pages 15202-15208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04376]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 061
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: 061'' (Recognition List Number: 061), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.
DATES: Submit either electronic or written comments on the notice at
any time. These modifications to the list of recognized standards are
applicable March 1, 2024.
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
[[Page 15203]]
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 061.'' 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: 061.
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: 061 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:
061 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: 061'' to Terry Woods, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Silver Spring, MD 20993, 301-796-2503. 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: Terry Woods, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD 20993, 301-796-2503,
[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: 061
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: 061'' 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
[[Page 15204]]
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: 061.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-73............. 1-162 ISO 10651-4 Second Withdrawn and
edition 2023-03 Lung replaced with
ventilators--Part 4: newer version.
Particular
requirements for
user-powered
resuscitators.
1-105............ 1-163 ISO 80601-2-72 Second Withdrawn and
edition 2023-06 replaced with
Medical electrical newer version.
equipment--Part 2-
72: Particular
requirements for
basic safety and
essential
performance of home
healthcare
environment
ventilators for
ventilator-dependent
patients.
1-118............ 1-164 ISO 5361 Fourth Withdrawn and
edition 2023-11 replaced with
Anaesthetic and newer version.
respiratory
equipment--Tracheal
tubes and connectors.
1-141............ 1-165 ISO 80601-2-13 Second Withdrawn and
edition 2022-04 replaced with
Medical electrical newer version.
equipment--Part 2-
13: Particular
requirements for
basic safety and
essential
performance of an
anaesthetic
workstation.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
2-94............. 2-302 ASTM F981-23 Standard Withdrawn and
Practice for replaced with
Assessment of Muscle newer version.
and Bone Tissue
Responses to Long-
Term Implantable
Materials Used in
Medical Devices.
2-237............ 2-303 ISO 10993-17 Second Withdrawn and
edition 2023-09 replaced with
Biological newer version.
evaluation of
medical devices--
Part 17:
Toxicological risk
assessment of
medical device
constituents.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-105............ ............ IEC 60601-2-25 Extent of
Edition 2.0 2011-10 recognition.
Medical electrical
equipment--Part 2-
25: Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs.
3-126............ ............ IEC 60601-2-27 Extent of
Edition 3.0 2011-03 recognition.
Medical electrical
equipment--Part 2-
27: Particular
requirements for the
basic safety and
essential
performance of
electrocardiographic
monitoring equipment
[Including:
Corrigendum 1
(2012)].
3-138............ 3-189 ASTM F2942-19 Withdrawn and
Standard Guide for replaced with
in vitro Axial, newer version.
Bending, and
Torsional Durability
Testing of Vascular
Stents.
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-137............ 4-309 ISO 6877 Third Withdrawn and
edition 2021-09 replaced with
Dentistry--Endodonti newer version.
c obturating
materials.
4-151............ 4-310 ISO 22112 Second Withdrawn and
edition 2017-08 replaced with
Dentistry--Artificia newer version.
l teeth for dental
prostheses.
4-188............ 4-311 ISO 9917-2 Third Withdrawn and
edition 2017-09 replaced with
Dentistry--Water- newer version.
based cements--Part
2: Resin-modified
cements.
4-190............ 4-312 ANSI/ASA S3.35-2021 Withdrawn and
American National replaced with
Standard Method for newer version.
Method of
Measurement of
Performance
Characteristics of
Hearing Aids Under
Simulated Real-Ear
Working Conditions.
4-218............ 4-313 ISO 27020 Second Withdrawn and
edition 2019-06 replaced with
Dentistry--Brackets newer version.
and tubes for use in
orthodontics.
4-221............ 4-314 ISO 7494-2 Third Withdrawn and
edition 2022-07 replaced with
Dentistry--Stationar newer version.
y dental units and
dental patient
chairs--Part 2: Air,
water, suction and
wastewater systems.
4-224............ 4-315 ISO 24234 Third Withdrawn and
edition 2021-08 replaced with
Dentistry--Dental newer version.
Amalgam.
4-238............ 4-316 ISO 20127 Second Withdrawn and
edition 2020-08 replaced with
Dentistry--Physical newer version.
properties of
powered toothbrushes.
4-244............ 4-317 ISO 8325 Third Withdrawn and
edition 2023-03 replaced with
Dentistry--Test newer version.
methods for rotary
instruments.
4-246............ 4-318 ISO 20749 Second Withdrawn and
edition 2023-06 replaced with
Dentistry--Pre- newer version.
capsulated dental
amalgam.
4-257............ 4-319 ISO 17730 Second Withdrawn and
edition 2020-09 replaced with
Dentistry--Fluoride newer version.
varnishes.
4-280............ ............ ANSI/ADA Standard No. Withdrawn with
117-2018 Fluoride transition. See
varnishes. 4-319.
------------------------------------------------------------------------
[[Page 15205]]
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-338............ 6-497 ASTM D7866-23 Withdrawn and
Standard replaced with
Specification for newer version.
Radiation
Attenuating
Protective Gloves.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-235............ 7-318 CLSI EP25 2nd Edition Withdrawn and
Evaluation of replaced with
Stability of In newer version.
Vitro Medical
Laboratory Test
Reagents.
7-304............ 7-319 CLSI M23 6th Edition Withdrawn and
Development of In replaced with
Vitro Susceptibility newer version.
Test Methods,
Breakpoints, and
Quality Control
Parameters.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-171............ 8-605 ASTM F1609-23 Withdrawn and
Standard replaced with
Specification for newer version.
Calcium Phosphate
Coatings for
Implantable
Materials.
8-412............ 8-606 ASTM F2537-23 Withdrawn and
Standard Practice replaced with
for Calibration of newer version.
Linear Displacement
Sensor Systems Used
to Measure
Micromotion.
8-437............ 8-607 ASTM F2082/F2082M-23 Withdrawn and
Determination of replaced with
Transformation newer version.
Temperature of
Nickel-Titanium
Shape Memory Alloys
by Bend and Free
Recovery.
8-451............ 8-608 ASTM F2214-2023 Withdrawn and
Standard Test Method replaced with
for In Situ newer version.
Determination of
Network Parameters
of Crosslinked Ultra
High Molecular
Weight Polyethylene
(UHMWPE).
8-475............ 8-609 ASTM F2026-23 Withdrawn and
Standard replaced with
Specification for newer version.
Polyetheretherketone
(PEEK) Polymers for
Surgical Implant
Applications.
8-483............ 8-610 ASTM F601-23 Standard Withdrawn and
Practice for replaced with
Fluorescent newer version.
Penetrant Inspection
of Metallic Surgical
Implants.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
11-83............ ............ ISO 13402 First Transferred. See
edition 1995-08-01 4-320.
Surgical and dental
hand instruments--
Determination of
resistance against
autoclaving,
corrosion and
thermal exposure.
11-276........... 11-402 ASTM F1798-21 Withdrawn and
Standard Test Method replaced with
for Evaluating the newer version.
Static and Fatigue
Properties of
Interconnection
Mechanisms and
Subassemblies Used
in Spinal
Arthrodesis Implants.
11-281........... ............ ASTM F1672-14 Withdrawn with
(Reapproved 2019) transition. See
Standard 11-400.
Specification for
Resurfacing Patellar
Prosthesis.
11-299........... ............ ASTM F2068-15 Withdrawn with
Standard transition. See
Specification for 11-401.
Femoral Prostheses--
Metallic Implants.
11-301........... ............ ASTM F2091-15 Withdrawn with
Standard transition. See
Specification for 11-401.
Acetabular
Prostheses.
11-303........... 11-403 ASTM F3047M-23 Withdrawn and
Standard Guide for replaced with
High Demand Hip newer version.
Simulator Wear
Testing of Hard-on-
Hard Articulations.
11-321........... 11-404 ASTM F2887-23 Withdrawn and
Standard replaced with
Specification for newer version.
Total Elbow
Prostheses.
[[Page 15206]]
11-334........... 11-405 ASTM F1829-23 Withdrawn and
Standard Test Method replaced with
for Static newer version.
Evaluation of
Anatomic Glenoid
Locking Mechanism in
Shear.
11-335........... 11-406 ASTM F3141-23 Withdrawn and
Standard Guide for replaced with
Total Knee newer version.
Replacement Loading
Profiles.
11-341........... 11-407 ASTM F3140-23 Withdrawn and
Standard Test Method replaced with
for Cyclic Fatigue newer version.
Testing of Metal
Tibial Tray
Components of
Unicondylar Knee
Joint Replacements.
11-377........... ............ ASTM F2083-21 Withdrawn with
Standard transition. See
Specification for 11-400.
Knee Replacement
Prosthesis.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-348........... ............ IEC 60601-2-54 Extent of
Edition 2.0 2022-09 recognition.
Medical electrical
equipment--Part 2-
54: Particular
requirements for the
basic safety and
essential
performance of X-ray
equipment for
radiography and
radioscopy.
12-349........... 12-352 NEMA PS 3.1-3.20 Withdrawn and
2023e Digital replaced with
Imaging and newer version.
Communications in
Medicine (DICOM) set.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-141........... 14-589 ISO 14644-4 Second Withdrawn and
edition 2022-11 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
4: Design,
construction and
start-up.
14-379........... 14-590 ISO 14644-8 Third Withdrawn and
edition 2022-06 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
8: Assessment of air
cleanliness by
chemical
concentration (ACC).
14-390........... 14-591 ISO 14644-10 Second Withdrawn and
edition 2022-05 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
10: Assessment of
surface cleanliness
for chemical
contamination.
14-427........... 14-592 ISO 13408-1 Third Withdrawn and
edition 2023-08 replaced with
Aseptic processing newer version.
of health care
products--Part 1:
General requirements.
14-516........... 14-593 ASTM F3039-23 Withdrawn and
Standard Test Method replaced with
for Detecting Leaks newer version.
in Nonporous
Packaging or
Flexible Barrier
Materials by Dye
Penetration.
14-530........... 14-594 ISO 11607-1 Second Withdrawn and
edition 2019-02 replaced with
[Including newer version.
ADM1:2023] Packaging
for terminally
sterilized medical
devices--Part 1:
Requirements for
materials, sterile
barrier systems and
packaging systems
[Including Amendment
1 (2023)].
14-531........... 14-595 ISO 11607-2 Second Withdrawn and
edition 2019-02 replaced with
[Including newer version.
AMD1:2023] Packaging
for terminally
sterilized medical
devices--Part 2:
Validation
requirements for
forming, sealing and
assembly processes
[Including Amendment
1 (2023)].
14-573........... 14-596 ASTM F88/F88M-23 Withdrawn and
Standard Test Method replaced with
for Seal Strength of newer version.
Flexible Barrier
Materials.
------------------------------------------------------------------------
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: 061. 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
------------------------------------------------------------------------
1-166.................... Gas mixers for medical ISO 11195 Second
use--Stand-alone gas edition 2018-01.
mixers..
------------------------------------------------------------------------
[[Page 15207]]
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-190.................... Sizing parameters of ISO/PAS 7020 First
surgical valve edition 2023-05.
prostheses:
Requirements regarding
the application of ISO
5840-2.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-320.................... Surgical and dental and ISO 13402 First
instruments--Determinat edition 1995-08.
ion of resistance
against autoclaving,
corrosion and thermal
exposure.
4-321.................... Dentistry--Intraoral ISO 23450 First
camera. edition 2021-03.
4-322.................... Dentistry--Machinable ISO 18675 First
ceramic blanks. edition 2022-05.
4-323.................... Dentistry--Polymer-based ISO 5139 First
composite machinable edition 2023-05.
blanks.
4-324.................... Dentistry--Polymer-based ISO/TS 16506 First
luting materials edition 2018-03.
containing adhesive
components.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
H. IVD
------------------------------------------------------------------------
7-320.................... Validation of Assays CLSI H62 1st
Performed by Flow Edition.
Cytometry.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
18-24.................... Standard Test Method for ASTM E2524-22.
Analysis of Hemolytic
Properties of
Nanoparticles.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
9-150.................... Copper-bearing ISO 7439 Fourth
contraceptive edition 2023-04.
intrauterine devices--
Requirements and tests.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
N. OrthopedicX
------------------------------------------------------------------------
11-400................... Non-active surgical ISO 21536 Third
implants--Joint edition 2023-07.
replacement implants--
Specific requirements
for knee-joint
replacement implants.
11-401................... Non-active surgical ISO 21535 Third
implants--Joint edition 2023-07.
replacement implants--
Specific requirements
for hip-joint
replacement implants.
11-408................... Standard Test Method for ASTM F2777-23.
Evaluating Knee Bearing
(Tibial Insert)
Endurance and
Deformation Under High
Flexion.
11-409................... Standard Test Methods ASTM F3495-23.
for Determining the
Static Failure Load of
Ceramic Knee Femoral
Components.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-353................... American National ANSI Z136.1-2022.
Standard for Safe Use
of Lasers.
------------------------------------------------------------------------
[[Page 15208]]
Q. Software/Informatics
------------------------------------------------------------------------
13-129................... Software and systems ISO/IEC/IEEE 29119-
engineering--Software 1 Second edition
testing--Part 1: 2022-01.
General concepts.
13-130................... Medical devices and ANSI/AAMI 2700-2-
medical systems-- 1:2022.
Essential safety and
performance
requirements for
equipment comprising
the patient-centric
integrated clinical
environment (ICE): Part
2-1: Particular
requirements for
forensic data logging.
13-131................... Standard for medical ANSI/AAMI
device security-- SW96:2023.
Security risk
management for device
manufacturers.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-597................... Water Quality for ANSI/AAMI
Processing Medical ST108:2023.
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.
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: February 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04376 Filed 2-29-24; 8:45 am]
BILLING CODE 4164-01-P
