Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062, 52473-52479 [2024-13777]
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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
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Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13776 Filed 6–21–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
062
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: 062’’
(Recognition List Number: 062), 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
June 24, 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
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
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52473
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: 062.’’ 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: 062.
• 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
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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
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: 062 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: 062
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: 062’’ 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
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 Division of
Standards and Conformity Assessment
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: 062
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: 062’’ 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: 062.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
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A. Anesthesiology
1–81 ............
1–167
1–97 ............
1–168
1–100 ..........
1–169
1–101 ..........
1–170
1–103 ..........
1–171
1–126 ..........
1–172
1–134 ..........
1–173
VerDate Sep<11>2014
18:55 Jun 21, 2024
CGA V–5:2019 Standard for Diameter Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications).
CGA V–7.1:2021 Standard Method of Determining Cylinder Valve Outlet
Connections for Medical Gases.
CGA V–1:2021 Standard for Compressed Gas Cylinder Valve Outlet and
Inlet Connections.
CGA C–9:2019 Standard Color Marking of Compressed Gas Containers
for Medical Use.
ISO 5367 Sixth edition 2023–07 Anaesthetic and respiratory equipment—
Breathing sets and connectors.
ISO 11712 Second edition 2023–11 Anaesthetic and respiratory equipment—Supralaryngeal airways and connectors.
ISO 18562–1 Second edition 2024–03 Biocompatibility evaluation of
breathing gas pathways in healthcare applications—Part 1: Evaluation
and testing within a risk management process.
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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.
Extent of recognition. 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.
1–135 ..........
1–174
1–136 ..........
1–175
1–137 ..........
1–176
1–138 ..........
1–177
Title of standard 1
Change
ISO 18562–2 Second edition 2024–03 Biocompatibility evaluation of
breathing gas pathways in healthcare applications—Part 2: Tests for
emissions of particulate matter.
ISO 18562–3 Second edition 2024–03 Biocompatibility evaluation of
breathing gas pathways in healthcare applications—Part 3: Tests for
emissions of volatile organic substances.
ISO 18562–4 Second edition 2024–03 Biocompatibility evaluation of
breathing gas pathways in healthcare applications—Part 4: Tests for
leachables in condensate.
ISO 80601–2–74 Second edition 2021–07 Medical electrical equipment—
Part 2–74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment.
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
No new entries at this time.
C. Cardiovascular
3–163 ..........
3–191
ISO 18242 First edition 2016–09–01 [Including AMD1:2023] Cardiovascular implants and extracorporeal systems—Centrifugal blood
pumps [Including AMENDMENT 1 (2023)].
Withdrawn and replaced with newer
version.
D. Dental/Ear, Nose, and Throat (ENT)
4–215 ..........
4–325
ANSI/ADA Standard No. 96–2020 Dental Water-based Cements ...............
Withdrawn and replaced with newer
version.
E. General I (Quality Systems/Risk Management) (QS/RM)
No new entries at this time.
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
19–19 ..........
19–50
IEC TS 60601–4–2 Edition 1.0 2024–03 Medical electrical equipment—
Part 4–2: Guidance and interpretation—Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
Withdrawn and replaced with newer
version.
G. General Hospital/General Plastic Surgery (GH/GPS)
6–295 ..........
6–322 ..........
......................
6–498
6–408 ..........
6–499
ANSI AAMI BF7:2012 Blood transfusion microfilters ...................................
ISO 10555–4 Third edition 2023–11 Intravascular catheters—Sterile and
single-use catheters—Part 4: Balloon dilatation catheters.
ISO 10555–1 Third edition 2023–11 Intravascular catheters—Sterile and
single-use catheters—Part 1: General requirements.
Withdrawn.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
H. In Vitro Diagnostics (IVD)
No new entries at this time.
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I. Materials
8–159 ..........
8–611
8–527 ..........
8–612
8–580 ..........
......................
8–581 ..........
......................
8–582 ..........
......................
VerDate Sep<11>2014
18:55 Jun 21, 2024
ISO 9584 Second edition 2023–10 Implants for surgery—Nondestructive
testing—Radiographic examination of cast metallic surgical implants.
ASTM F899–23 Standard Specification for Wrought Stainless Steels for
Surgical Instruments.
IEC 63145–20–10 Edition 1.0 2019–08 Eyewear display—Part 20–10:
Fundamental measurement methods—Optical properties.
IEC 63145–20–20 Edition 1.0 2019–09 Eyewear display—Part 20–20:
Fundamental measurement methods—Image quality.
IEC 63145–22–10 Edition 1.0 2020–01 Eyewear display—Part 22–10:
Specific measurement methods for AR type—Optical properties.
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Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Transferred. See 12–357.
Transferred. See 12–358.
Transferred. See 12–359.
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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
Title of standard 1
Change
J. Nanotechnology
No new entries at this time.
K. Neurology
17–13 ..........
17–18
IEEE Std 2010–2023 Recommended Practice for Electroencephalography
(EEG) Neurofeedback Systems.
Withdrawn and replaced with newer
version.
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
No new entries at this time.
M. Ophthalmic
10–56 ..........
......................
10–70 ..........
10–134
10–125 ........
10–135
10–126 ........
10–136
ANSI Z80.12–2007 (R2022) American National Standard for
Ophthalmics—Multifocal Intraocular Lenses.
ISO 10943 Fourth edition 2023–01—ophthalmic instruments—Indirect
ophthalmoscopes.
ISO 11979–7 Fifth edition 2024–01 Ophthalmic implants—Intraocular
lenses—Part 7: Clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
IEC 80601–2–58 Edition 3.0 2024–03 Medical electrical equipment—Part
2–58: Particular requirements for basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic
surgery.
Withdrawn with transition. See 10–
135.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
N. Orthopedic
No new entries at this time.
O. Physical Medicine
No new entries at this time.
P. Radiology
12–232 ........
12–354
12–242 ........
12–355
12–268 ........
12–356
NEMA MS 4–2023 Acoustic Noise Measurement Procedure for Magnetic
Resonance Equipment.
IEC 60601–2–57 Edition 2.0 2023–07 Medical Electrical Equipment—Part
2–57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,
diagnostic, monitoring, cosmetic and aesthetic use.
IEC 60601–2–22 Edition 4.0 2019–11 Medical electrical equipment—Part
2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
Withdrawn and replaced with newer
version.
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Q. Software/Informatics
13–52 ..........
13–132
13–53 ..........
13–133
13–54 ..........
13–134
13–57 ..........
13–135
13–113 ........
13–136
13–114 ........
13–137
ISO/IEEE 11073–10408 Second edition 2022–12 Health informatics—
Point-of-care medical device communication—Part 10408: Device specialization—Thermometer.
ISO/IEEE 11073–10415 Second edition 2022–12 Health informatics—
Point-of-care medical device communication—Part 10415: Device
specialization- Weighing scale.
ISO/IEEE 11073–10404 Second edition 2022–12 Health informatics—Personal health device communication—Part 10404: Device specialization—Pulse oximeter.
ISO/IEEE 11073–10407 Second edition 2022–12 Health informatics—Personal health device communication—Part 10407: Device Specialization—Blood pressure monitor.
ISO/IEEE 11073–20601 Third Edition 2022–12 Health informatics—Personal health device communication—Part 20601: Application profile—
Optimized exchange protocol.
IEEE Std 11073–10101b–2023 Health informatics—Point-of-care medical
device communication—Part 10101: Nomenclature.
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.
R. Sterility
14–242 ........
VerDate Sep<11>2014
14–598
18:55 Jun 21, 2024
ISO 14644–3 Second edition 2020–06 Cleanrooms and associated controlled environments—Part 3: Test methods.
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TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old
recognition
No.
Replacement
recognition
No.
14–243 ........
......................
14–277 ........
......................
14–333 ........
......................
14–389 ........
14–599
14–484 ........
14–600
Title of standard 1
Change
ISO 14644–6 First edition 2007–07 Cleanrooms and associated controlled
environments—Part 6: Vocabulary.
ISO TS 17665–2 First edition 2009–01 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665–1.
ISO 17665–1 First edition 2006–08 Sterilization of health care products—
Moist heat—Part 1: Requirements for the development, validation and
routine control of a sterilization process for medical devices.
ISO 14644–9 Second edition Cleanrooms and associated controlled environments—Part 9: Assessment of surface cleanliness for particle concentration.
ASTM F1929–23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Withdrawn.
Withdrawn with transition. See 14–
601.
Withdrawn with transition. See 14–
601.
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
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: 062. 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
1–178 .................
1–179 .................
Anaesthetic and respiratory equipment—Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans.
Anaesthetic and respiratory equipment—Spirometers intended for the measurement of time forced expired volumes in humans [Including: Technical Corrigendum 1 (2009)].
ISO 23747 Second edition 2015–08.
ISO 26782 First edition 2009–07.
B. Biocompatibility
No new entries at this time.
C. Cardiovascular
3–192 .................
Cardiovascular implants—Transcatheter cardiac occluders .....................................
ISO 22679 First edition 2021–11.
D. Dental/ENT
4–326 .................
4–327 .................
Dentistry—Graphical symbols for dental equipment [Including AMENDMENT 1
(2018)].
Dentistry—Graphical symbols for dental instruments ...............................................
ISO 9687 Second edition 2015–02.
ISO 21531 First edition 2009–02.
E. General I (QS/RM)
5–142 .................
Packaging—Distribution packaging—Graphical symbols for handling and storage
of packages.
ISO 780 Fifth edition 2015–12–01.
F. General II (ES/EMC)
No new entries at this time.
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G. GH/GPS
6–500 .................
6–501 .................
6–502 .................
VerDate Sep<11>2014
Ultrasonics—Non-focusing short pressure pulse sources including ballistic pressure pulse sources—Characteristics of fields.
Plastic containers for intravenous injections .............................................................
Injection systems for self-administration by paediatric patients—Requirements and
guidelines for design.
18:55 Jun 21, 2024
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IEC 63045 Edition 1.0 2020–05.
ISO 15747 Third edition 2018–09.
ISO 23217 First edition 2024–02.
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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
H. IVD
7–321 .................
Molecular Methods for Genotyping and Strain Typing of Infectious Organisms ......
CLSI MM24 1st Edition.
I. Materials
8–613 .................
8–614 .................
8–615 .................
8–616 .................
8–617 .................
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt
Alloy Small Diameter Tubing for Surgical Implants.
Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for
Medical Applications for Additive Manufacturing Feedstock Materials.
Additive manufacturing of metals—Qualification principles—Part 1: General qualification of operators.
Additive manufacturing of metals—Qualification principles—Part 2: Qualification of
operators for PBF–LB.
Additive manufacturing of metals—Qualification principles—Part 3: Qualification of
operators for PBF–EB.
ASTM F2527–24.
ASTM F3456–22.
ISO/ASTM 52926–1 First edition 2023–
11.
ISO/ASTM 52926–2 First edition 2023–
11.
ISO/ASTM 52926–3 First edition 2023–
11.
J. Nanotechnology
No new entries at this time.
K. Neurology
17–19 .................
Medical electrical equipment—Part 2–85: Particular requirements for the basic
safety and essential performance of cerebral tissue oximeter equipment.
ISO 80601–2–85 Edition 1.0 2021–03.
L. OB-Gyn/G/Urology
No new entries at this time.
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
12–357 ...............
12–358 ...............
12–359 ...............
12–360 ...............
12–361 ...............
Eyewear display—Part 20–10: Fundamental measurement methods—Optical
properties.
Eyewear display—Part 20–20: Fundamental measurement methods—Image quality.
Eyewear display—Part 22–10: Specific measurement methods for AR type—Optical properties.
Eyewear display—Part 10: Specifications .................................................................
Information Display Measurements Standard ...........................................................
IEC 63145–20–10 Edition 1.0 2019–08.
IEC 63145–20–20 Edition 1.0 2019–09.
IEC 63145–22–10 Edition 1.0 2020–01.
IEC 63145–10 Edition 1.0 2023–09.
ICDM IDMS Version 1.2 May 2023.
Q. Software/Informatics
13–138 ...............
13–139 ...............
Health Informatics—Device Interoperability Part 10700: Point-of-Care Medical Device Communication—Standard for Base Requirements for Participants in a
Service-Oriented Device Connectivity (SDC) System.
Health informatics—Device interoperability—Part 10206: Personal health device
communication—Abstract Content Information Model.
IEEE Std 11073–10700–2022.
IEEE Std 11073–10206–2022.
lotter on DSK11XQN23PROD with NOTICES1
R. Sterility
14–601 ...............
14–602 ...............
14–603 ...............
VerDate Sep<11>2014
Sterilization of health care products—Moist heat—Requirements for the development, validation and routine control of a sterilization process for medical devices.
Designing, testing, and labeling medical devices intended for processing by
health care facilities: A guide for device manufacturers.
Product adoption and process equivalence for ethylene oxide sterilization .............
18:55 Jun 21, 2024
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E:\FR\FM\24JNN1.SGM
ISO 17665 First edition 2024–03.
AAMI TIR12:2020/(R)2023.
AAMI TIR28:2016/(R)2020.
24JNN1
Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
52479
TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Title of standard 1
Recognition No.
Reference No. and date
S. Tissue Engineering
No new entries at this time.
1 All
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the current list of FDA
Recognized Consensus Standards in a
searchable database that may be
accessed at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. Such
standards are those that FDA has
recognized by notice published in the
Federal Register or that FDA has
decided to recognize but for which
recognition is pending (because a
periodic notice has not yet appeared in
the Federal Register). FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often if necessary.
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to
CDRHStandardsStaff@fda.hhs.gov. To
be considered, such recommendations
should contain, at a minimum, the
information available at https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/standards-and-conformityassessment-program#process.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13777 Filed 6–21–24; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Applications for and
Monitoring of New, One-Time Funding
Programs Administered by the Health
Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than July 24, 2024.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Joella Roland, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Applications for and Monitoring of
New, One-Time Funding Programs
Administered by the Health Resources
DATES:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
and Services Administration (HRSA)—
OMB Control No. 0906–xxxx–New
Abstract: HRSA is seeking approval
for a generic umbrella clearance to
collect applications for awards for
HRSA-funded programs that provide
one-time funding, including pilot
programs. Should any of these pilot
programs become permanent, HRSA
will seek OMB clearance for these
programs using a mechanism outside of
this generic umbrella clearance. OMB
guidance allows for the use of generic
packages in cases where there may be a
need for a data collection, but the
agency ‘‘cannot determine the details of
the specific individual collections until
a later time.’’ 1 HRSA will only use this
collection for HRSA-funded programs
that provide one-time funding,
including pilot programs. HRSA would
only request OMB approval for
collections under this generic umbrella
collection if the collection is lowburden, uncontroversial, and is a onetime application.
Furthermore, if Congress appropriates
additional funding for such a program
or HRSA plans to use the information
from the applications for policy
decisions not related to funding awards,
HRSA will prepare a standard
information collection request for that
program, which will include the
required 60- and 30-day Federal
Register notices.
A 60-day notice published in the
Federal Register on March 22, 2024,
vol. 89, No. 57; pp. 20484–85. There
were no public comments.
Need and Proposed Use of the
Information: HRSA seeks to use an
umbrella generic clearance for HRSAfunded programs that provide one-time
funding, including pilot programs, so
that funding can be awarded
expeditiously. Expeditious awarding of
funding is helpful not only for
administrative ease, but also for cases in
which a pilot program or a program
receiving one-time funding has a
statutory deadline for completion.
Approval of this proposed generic
1 Memorandum for the Heads of Executive
Departments and Agencies and Independent
Regulatory Agencies (July 2016), ‘‘Flexibilities
under the Paperwork Reduction Act for Compliance
with Information Collection Requirements.’’ Pages
4–5.
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52473-52479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13777]
-----------------------------------------------------------------------
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: 062
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: 062'' (Recognition List Number: 062), 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 June 24, 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 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: 062.'' 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: 062.
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
[[Page 52474]]
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: 062 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:
062 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: 062'' 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 Division of Standards and
Conformity Assessment 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: 062
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: 062'' 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: 062.
Table 1--Modifications to the List of Recognized Standards
------------------------------------------------------------------------
Replacement
Old recognition recognition Title of standard \1\ Change
No. No.
------------------------------------------------------------------------
A. Anesthesiology
------------------------------------------------------------------------
1-81............. 1-167 CGA V-5:2019 Standard Withdrawn and
for Diameter Index replaced with
Safety System newer version.
(Noninterchangeable
Low Pressure
Connections for
Medical Gas
Applications).
1-97............. 1-168 CGA V-7.1:2021 Withdrawn and
Standard Method of replaced with
Determining Cylinder newer version.
Valve Outlet
Connections for
Medical Gases.
1-100............ 1-169 CGA V-1:2021 Standard Withdrawn and
for Compressed Gas replaced with
Cylinder Valve newer version.
Outlet and Inlet
Connections.
1-101............ 1-170 CGA C-9:2019 Standard Withdrawn and
Color Marking of replaced with
Compressed Gas newer version.
Containers for
Medical Use.
1-103............ 1-171 ISO 5367 Sixth Extent of
edition 2023-07 recognition.
Anaesthetic and Withdrawn and
respiratory replaced with
equipment--Breathing newer version.
sets and connectors.
1-126............ 1-172 ISO 11712 Second Withdrawn and
edition 2023-11 replaced with
Anaesthetic and newer version.
respiratory
equipment--Supralary
ngeal airways and
connectors.
1-134............ 1-173 ISO 18562-1 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
1: Evaluation and
testing within a
risk management
process.
[[Page 52475]]
1-135............ 1-174 ISO 18562-2 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
2: Tests for
emissions of
particulate matter.
1-136............ 1-175 ISO 18562-3 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
3: Tests for
emissions of
volatile organic
substances.
1-137............ 1-176 ISO 18562-4 Second Withdrawn and
edition 2024-03 replaced with
Biocompatibility newer version.
evaluation of
breathing gas
pathways in
healthcare
applications--Part
4: Tests for
leachables in
condensate.
1-138............ 1-177 ISO 80601-2-74 Second Withdrawn and
edition 2021-07 replaced with
Medical electrical newer version.
equipment--Part 2-
74: Particular
requirements for
basic safety and
essential
performance of
respiratory
humidifying
equipment.
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-163............ 3-191 ISO 18242 First Withdrawn and
edition 2016-09-01 replaced with
[Including newer version.
AMD1:2023]
Cardiovascular
implants and
extracorporeal
systems--Centrifugal
blood pumps
[Including AMENDMENT
1 (2023)].
------------------------------------------------------------------------
D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-215............ 4-325 ANSI/ADA Standard No. Withdrawn and
96-2020 Dental Water- replaced with
based Cements. newer version.
------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-19............ 19-50 IEC TS 60601-4-2 Withdrawn and
Edition 1.0 2024-03 replaced with
Medical electrical newer version.
equipment--Part 4-2:
Guidance and
interpretation--Elec
tromagnetic
immunity:
performance of
medical electrical
equipment and
medical electrical
systems.
------------------------------------------------------------------------
G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-295............ ............ ANSI AAMI BF7:2012 Withdrawn.
Blood transfusion
microfilters.
6-322............ 6-498 ISO 10555-4 Third Withdrawn and
edition 2023-11 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 4:
Balloon dilatation
catheters.
6-408............ 6-499 ISO 10555-1 Third Withdrawn and
edition 2023-11 replaced with
Intravascular newer version.
catheters--Sterile
and single-use
catheters--Part 1:
General requirements.
------------------------------------------------------------------------
H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-159............ 8-611 ISO 9584 Second Withdrawn and
edition 2023-10 replaced with
Implants for newer version.
surgery--Nondestruct
ive testing--
Radiographic
examination of cast
metallic surgical
implants.
8-527............ 8-612 ASTM F899-23 Standard Withdrawn and
Specification for replaced with
Wrought Stainless newer version.
Steels for Surgical
Instruments.
8-580............ ............ IEC 63145-20-10 Transferred. See
Edition 1.0 2019-08 12-357.
Eyewear display--
Part 20-10:
Fundamental
measurement methods--
Optical properties.
8-581............ ............ IEC 63145-20-20 Transferred. See
Edition 1.0 2019-09 12-358.
Eyewear display--
Part 20-20:
Fundamental
measurement methods--
Image quality.
8-582............ ............ IEC 63145-22-10 Transferred. See
Edition 1.0 2020-01 12-359.
Eyewear display--
Part 22-10: Specific
measurement methods
for AR type--Optical
properties.
------------------------------------------------------------------------
[[Page 52476]]
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-13............ 17-18 IEEE Std 2010-2023 Withdrawn and
Recommended Practice replaced with
for newer version.
Electroencephalograp
hy (EEG)
Neurofeedback
Systems.
------------------------------------------------------------------------
L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
M. Ophthalmic
------------------------------------------------------------------------
10-56............ ............ ANSI Z80.12-2007 Withdrawn with
(R2022) American transition. See
National Standard 10-135.
for Ophthalmics--
Multifocal
Intraocular Lenses.
10-70............ 10-134 ISO 10943 Fourth Withdrawn and
edition 2023-01-- replaced with
ophthalmic newer version.
instruments--Indirec
t ophthalmoscopes.
10-125........... 10-135 ISO 11979-7 Fifth Withdrawn and
edition 2024-01 replaced with
Ophthalmic implants-- newer version.
Intraocular lenses--
Part 7: Clinical
investigations of
intraocular lenses
that are implanted
in the eye in order
to correct aphakia.
10-126........... 10-136 IEC 80601-2-58 Withdrawn and
Edition 3.0 2024-03 replaced with
Medical electrical newer version.
equipment--Part 2-
58: Particular
requirements for
basic safety and
essential
performance of lens
removal devices and
vitrectomy devices
for ophthalmic
surgery.
------------------------------------------------------------------------
N. Orthopedic
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
O. Physical Medicine
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
P. Radiology
------------------------------------------------------------------------
12-232........... 12-354 NEMA MS 4-2023 Withdrawn and
Acoustic Noise replaced with
Measurement newer version.
Procedure for
Magnetic Resonance
Equipment.
12-242........... 12-355 IEC 60601-2-57 Withdrawn and
Edition 2.0 2023-07 replaced with
Medical Electrical newer version.
Equipment--Part 2-
57: Particular
requirements for the
basic safety and
essential
performance of non-
laser light source
equipment intended
for therapeutic,
diagnostic,
monitoring, cosmetic
and aesthetic use.
12-268........... 12-356 IEC 60601-2-22 Withdrawn and
Edition 4.0 2019-11 replaced with
Medical electrical newer version.
equipment--Part 2-
22: Particular
requirements for
basic safety and
essential
performance of
surgical, cosmetic,
therapeutic and
diagnostic laser
equipment.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-52............ 13-132 ISO/IEEE 11073-10408 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Point-
of-care medical
device
communication--Part
10408: Device
specialization--Ther
mometer.
13-53............ 13-133 ISO/IEEE 11073-10415 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Point-
of-care medical
device
communication--Part
10415: Device
specialization-
Weighing scale.
13-54............ 13-134 ISO/IEEE 11073-10404 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
10404: Device
specialization--Puls
e oximeter.
13-57............ 13-135 ISO/IEEE 11073-10407 Withdrawn and
Second edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
10407: Device
Specialization--Bloo
d pressure monitor.
13-113........... 13-136 ISO/IEEE 11073-20601 Withdrawn and
Third Edition 2022- replaced with
12 Health newer version.
informatics--Persona
l health device
communication--Part
20601: Application
profile--Optimized
exchange protocol.
13-114........... 13-137 IEEE Std 11073-10101b- Withdrawn and
2023 Health replaced with
informatics--Point- newer version.
of-care medical
device
communication--Part
10101: Nomenclature.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-242........... 14-598 ISO 14644-3 Second Withdrawn and
edition 2020-06 replaced with
Cleanrooms and newer version.
associated
controlled
environments--Part
3: Test methods.
[[Page 52477]]
14-243........... ............ ISO 14644-6 First Withdrawn.
edition 2007-07
Cleanrooms and
associated
controlled
environments--Part
6: Vocabulary.
14-277........... ............ ISO TS 17665-2 First Withdrawn with
edition 2009-01 transition. See
Sterilization of 14-601.
health care
products--Moist
heat--Part 2:
Guidance on the
application of ISO
17665-1.
14-333........... ............ ISO 17665-1 First Withdrawn with
edition 2006-08 transition. See
Sterilization of 14-601.
health care
products--Moist
heat--Part 1:
Requirements for the
development,
validation and
routine control of a
sterilization
process for medical
devices.
14-389........... 14-599 ISO 14644-9 Second Withdrawn and
edition Cleanrooms replaced with
and associated newer version.
controlled
environments--Part
9: Assessment of
surface cleanliness
for particle
concentration.
14-484........... 14-600 ASTM F1929-23 Withdrawn and
Standard Test Method replaced with
for Detecting Seal newer version.
Leaks in Porous
Medical Packaging by
Dye Penetration.
------------------------------------------------------------------------
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: 062. 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
------------------------------------------------------------------------
1-178.................... Anaesthetic and ISO 23747 Second
respiratory equipment-- edition 2015-08.
Peak expiratory flow
meters for the
assessment of pulmonary
function in
spontaneously breathing
humans.
1-179.................... Anaesthetic and ISO 26782 First
respiratory equipment-- edition 2009-07.
Spirometers intended
for the measurement of
time forced expired
volumes in humans
[Including: Technical
Corrigendum 1 (2009)].
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
C. Cardiovascular
------------------------------------------------------------------------
3-192.................... Cardiovascular implants-- ISO 22679 First
Transcatheter cardiac edition 2021-11.
occluders.
------------------------------------------------------------------------
D. Dental/ENT
------------------------------------------------------------------------
4-326.................... Dentistry--Graphical ISO 9687 Second
symbols for dental edition 2015-02.
equipment [Including
AMENDMENT 1 (2018)].
4-327.................... Dentistry--Graphical ISO 21531 First
symbols for dental edition 2009-02.
instruments.
------------------------------------------------------------------------
E. General I (QS/RM)
------------------------------------------------------------------------
5-142.................... Packaging--Distribution ISO 780 Fifth
packaging--Graphical edition 2015-12-
symbols for handling 01.
and storage of packages.
------------------------------------------------------------------------
F. General II (ES/EMC)
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
G. GH/GPS
------------------------------------------------------------------------
6-500.................... Ultrasonics--Non- IEC 63045 Edition
focusing short pressure 1.0 2020-05.
pulse sources including
ballistic pressure
pulse sources--
Characteristics of
fields.
6-501.................... Plastic containers for ISO 15747 Third
intravenous injections. edition 2018-09.
6-502.................... Injection systems for ISO 23217 First
self-administration by edition 2024-02.
paediatric patients--
Requirements and
guidelines for design.
------------------------------------------------------------------------
[[Page 52478]]
H. IVD
------------------------------------------------------------------------
7-321.................... Molecular Methods for CLSI MM24 1st
Genotyping and Strain Edition.
Typing of Infectious
Organisms.
------------------------------------------------------------------------
I. Materials
------------------------------------------------------------------------
8-613.................... Standard Specification ASTM F2527-24.
for Wrought Seamless
and Welded and Drawn
Cobalt Alloy Small
Diameter Tubing for
Surgical Implants.
8-614.................... Standard Guide for ASTM F3456-22.
Powder Reuse Schema in
Powder Bed Fusion
Processes for Medical
Applications for
Additive Manufacturing
Feedstock Materials.
8-615.................... Additive manufacturing ISO/ASTM 52926-1
of metals-- First edition 2023-
Qualification 11.
principles--Part 1:
General qualification
of operators.
8-616.................... Additive manufacturing ISO/ASTM 52926-2
of metals-- First edition 2023-
Qualification 11.
principles--Part 2:
Qualification of
operators for PBF-LB.
8-617.................... Additive manufacturing ISO/ASTM 52926-3
of metals-- First edition 2023-
Qualification 11.
principles--Part 3:
Qualification of
operators for PBF-EB.
------------------------------------------------------------------------
J. Nanotechnology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
K. Neurology
------------------------------------------------------------------------
17-19.................... Medical electrical ISO 80601-2-85
equipment--Part 2-85: Edition 1.0 2021-
Particular requirements 03.
for the basic safety
and essential
performance of cerebral
tissue oximeter
equipment.
------------------------------------------------------------------------
L. OB-Gyn/G/Urology
------------------------------------------------------------------------
No new entries at this time.
------------------------------------------------------------------------
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
------------------------------------------------------------------------
12-357................... Eyewear display--Part 20- IEC 63145-20-10
10: Fundamental Edition 1.0 2019-
measurement methods-- 08.
Optical properties.
12-358................... Eyewear display--Part 20- IEC 63145-20-20
20: Fundamental Edition 1.0 2019-
measurement methods-- 09.
Image quality.
12-359................... Eyewear display--Part 22- IEC 63145-22-10
10: Specific Edition 1.0 2020-
measurement methods for 01.
AR type--Optical
properties.
12-360................... Eyewear display--Part IEC 63145-10
10: Specifications. Edition 1.0 2023-
09.
12-361................... Information Display ICDM IDMS Version
Measurements Standard. 1.2 May 2023.
------------------------------------------------------------------------
Q. Software/Informatics
------------------------------------------------------------------------
13-138................... Health Informatics-- IEEE Std 11073-
Device Interoperability 10700-2022.
Part 10700: Point-of-
Care Medical Device
Communication--Standard
for Base Requirements
for Participants in a
Service-Oriented Device
Connectivity (SDC)
System.
13-139................... Health informatics-- IEEE Std 11073-
Device 10206-2022.
interoperability--Part
10206: Personal health
device communication--
Abstract Content
Information Model.
------------------------------------------------------------------------
R. Sterility
------------------------------------------------------------------------
14-601................... Sterilization of health ISO 17665 First
care products--Moist edition 2024-03.
heat--Requirements for
the development,
validation and routine
control of a
sterilization process
for medical devices.
14-602................... Designing, testing, and AAMI TIR12:2020/
labeling medical (R)2023.
devices intended for
processing by health
care facilities: A
guide for device
manufacturers.
14-603................... Product adoption and AAMI TIR28:2016/
process equivalence for (R)2020.
ethylene oxide
sterilization.
------------------------------------------------------------------------
[[Page 52479]]
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: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13777 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P
