Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability, 63589-63591 [2023-20029]
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Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
unintended consequences might be
unique to stakeholders like you? Why?
6. FDA anticipates that each
establishment would be provided with a
detailed report following their QMM
assessment. What would you want such
a report to contain?
7. With respect to the outcomes of a
QMM assessment, what are your
thoughts about making outcomes
public? Would your thoughts be
different if the outcomes were generally
qualitative (e.g., descriptive
information) versus quantitative (e.g., a
numerical rating)?
8. What other feedback would you
like the FDA to consider for a voluntary
QMM program?
III. References
The following references are on
display with the Dockets Management
Staff (see ADDRESSES) and are available
for viewing by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday; these are not available
electronically at https://
www.regulations.gov as these references
are copyright protected. Some may be
available at the website address, if
listed. FDA has verified the website
addresses, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
1. Maguire, J., A. Fisher, D. Harouaka, N.
Rakala, et al., 2023, ‘‘Lessons from
CDER’s Quality Management Maturity
Pilot Programs,’’ The AAPS Journal,
25(14), January 10, 2023, https://doi.org/
10.1208/s12248-022-00777-z.
2. Fellows, M., T. Friedli, Y. Li, J. Maguire,
et al., 2022, ‘‘Benchmarking the Quality
Practices of Global Pharmaceutical
Manufacturing to Advance Supply Chain
Resilience,’’ The AAPS Journal, 24(111),
October 20, 2022, https://doi.org/
10.1208/s12248-022-00761-7.
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–20015 Filed 9–14–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2019–N–4060]
Medical Devices With Indications
Associated With Weight Loss
Guidances; Draft Guidances for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
ACTION:
Notice of availability.
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
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
Food and Drug Administration,
HHS.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of two draft
guidances entitled ‘‘Medical Devices
with Indications Associated with
Weight Loss—Clinical Study and
Benefit-Risk Considerations’’ and
‘‘Medical Devices with Indications
Associated with Weight Loss—NonClinical Recommendations.’’ These draft
guidance documents provide
recommendations regarding clinical
study design for devices with
indications for use associated with
weight loss, include discussion on how
FDA considers the benefit-risk analysis
to support such indications, and
provide recommendations for the nonclinical testing to support premarket
submissions for these medical devices.
These draft guidances are not final nor
are they for implementation at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by November 14, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
PO 00000
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63589
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–
2019–N–4060 for ‘‘Medical Devices with
Indications Associated with Weight
Loss—Clinical Study and Benefit-Risk
Considerations’’ and ‘‘Medical Devices
with Indications Associated with
Weight Loss—Non-Clinical
Recommendations.’’ 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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\15SEN1.SGM
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Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
‘‘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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Medical Devices
with Indications Associated with
Weight Loss—Clinical Study and
Benefit-Risk Considerations’’ or
‘‘Medical Devices with Indications
Associated with Weight Loss—NonClinical Recommendations’’ to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
April Marrone, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2604, Silver Spring,
MD 20993–0002, 240–402–6510.
SUPPLEMENTARY INFORMATION:
I. Background
These draft guidance documents
provide recommendations regarding
clinical study design for devices with
indications for use associated with
weight loss, include discussion on how
FDA considers the benefit-risk analysis
to support such indications, and
provide recommendations for nonclinical testing to support premarket
submissions for these medical devices.
These devices may be indicated for
weight loss, weight reduction, weight
management, or obesity treatment in
patients who are overweight or have
obesity. The recommendations and
considerations reflect current review
practices and are intended to promote
consistency and facilitate efficient
review of these submissions.
Prior to drafting these guidances, FDA
requested public comment on a concept
for balancing the benefit of weight loss
with the risks of adverse events in a
discussion paper (September 2019,
Docket No. FDA–2019–N–4060). FDA
considered public comments and
incorporated the feedback as
appropriate in developing the draft
guidance, ‘‘Medical Devices with
Indications Associated with Weight
Loss—Clinical Study and Benefit-Risk
Considerations.’’
These draft guidances are being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). These draft guidance
documents, when finalized, will
represent the current thinking of FDA
on ‘‘Medical Devices with Indications
Associated with Weight Loss—Clinical
Study and Benefit-Risk Considerations’’
and ‘‘Medical Devices with Indications
Associated with Weight Loss—NonClinical Recommendations.’’ They do
not establish any rights for any person
and are not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Persons unable to download an
electronic copy of ‘‘Medical Devices
with Indications Associated with
Weight Loss—Clinical Study and
Benefit-Risk Considerations (document
number GUI00021016)’’ or ‘‘Medical
Devices with Indications Associated
with Weight Loss—Non-Clinical
Recommendations (document number
GUI00019046)’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number and complete title to identify
the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following table have
been approved by OMB:
OMB
control No.
21 CFR part or guidance
Topic
807, subpart E .................................................................
814, subparts A through E ..............................................
812 ...................................................................................
860, subpart D .................................................................
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’.
800, 801, 809, and 830 ...................................................
820 ...................................................................................
Premarket notification ...........................................................................
Premarket approval ...............................................................................
Investigational Device Exemption .........................................................
De Novo classification process .............................................................
Q-Submissions and Early Payor Feedback Request Programs for
Medical Devices.
Medical Device Labeling Regulations; Unique Device Identification ....
Current Good Manufacturing Practice (CGMP); Quality System (QS)
Regulation.
Protection of Human Subjects: Informed Consent; Institutional Review Boards.
Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies.
50, 56 ...............................................................................
58 .....................................................................................
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II. Electronic Access
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0910–0120
0910–0231
0910–0078
0910–0844
0910–0756
0910–0485
0910–0073
0910–0130
0910–0119
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
government-wide. Additionally, the
different provisions may result in report
submission delays, which can affect
closeout task reconciliation and
effective completion. Adhering to the 2
CFR 200.344 closeout provisions would
provide more time for recipient
compliance and conform with other
Federal awarding agencies, thus
promoting greater equity and fairness.
Action: For the reasons stated above,
effective October 1, 2023, HHS will
follow the 2 CFR 200.344 closeout
provisions This action will minimize
the burden on the internal and external
grants communities while ensuring the
timely closeout of HHS awards.
[FR Doc. 2023–20029 Filed 9–14–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Change in Federal Award Closeout
Provisions
Office of the Assistant
Secretary for Financial Resources
(ASFR), Department of Health and
Human Services (HHS or the
Department).
ACTION: Notice.
AGENCY:
HHS will follow the Federal
award Office of Management and
Budget (OMB) closeout provisions
modified the closeout provisions rather
than the HHS-specific closeout
provisions.
FOR FURTHER INFORMATION CONTACT:
Johanna Nestor at Johanna.Nestor@
hhs.gov or (202) 631–0420.
SUPPLEMENTARY INFORMATION:
Background: In 2014, HHS codified
the Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements (UAR) for HHS
Awards at 45 CFR part 75. 79 FR 75889
(Dec. 19, 2014). This codification
included HHS-specific language,
including the adoption of the closeout
provisions at 45 CFR 75.381. In 2020,
the Office of Management and Budget
modified the closeout provisions for
Federal awards at 2 CFR 200.344. 85 FR
49506 (Aug. 13, 2020). These
modifications:
• Increase the number of days for
recipients to submit closeout reports
and liquidate all financial obligations
from 90 calendar days to 120 calendar
days after the end of the period of
performance.
• Require awarding agencies to
complete closeout actions no later than
one year after the end of the period of
performance unless otherwise directed
by authorizing statutes.
• Require awarding agencies to close
out awards within one year of the end
of the period of performance based on
available information and report the
recipient to the OMB-designated
integrity and performance system
(currently Federal Awardee
Performance and Integrity Information
System (FAPIIS)).
The HHS-specific closeout provisions
at 45 CFR 75.381 are more restrictive
than 2 CFR 200.344 as modified. This
may lead to recipient confusion and
inconsistencies in closeout timing
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
William D. Bell IV,
Deputy Assistant Secretary for Grants.
[FR Doc. 2023–19954 Filed 9–14–23; 8:45 am]
BILLING CODE 4150–24–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer at (240) 276–
0361.
Comments are invited on: (a) whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: National Substance
Use and Mental Health Services Survey
(N–SUMHSS) (OMB No. 0930–0386)—
Revision
Under section 505 of the Public
Health Service Act (42 U.S.C. 290aa–4),
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SAMHSA is required to conduct annual
collection of data on substance use and
mental health. Selected information
collected from the N–SUMHSS is also
published on SAMHSA’s
FindTreatment.gov for persons seeking
treatment for mental and substance use
disorders in the United States.
FindTreatment.gov is authorized by the
21st Century Cures Act (Pub. L. 114–
255, section 9006; 42 U.S.C. 290bb–
36d).
In 2021, SAMHSA combined the
National Survey of Substance Abuse
Treatment Services (N–SSATS) and the
National Mental Health Services Survey
(N–MHSS) into the N–SUMHSS to
reduce the burden on facilities offering
both substance use and mental health
services, optimize government resources
to collect data, and enhance the quality
of data collected on the treatment
facilities.
The N–SUMHSS is the most
comprehensive national source of data
on substance use and mental health
treatment facilities. On an annual basis,
the N–SUMHSS collects information on
the facility location, characteristics, and
utilization of substance use and mental
health treatment services. The survey
also collects client counts on
individuals receiving services at these
facilities. There is an increasing need to
collect and maintain data on current
and accurate numbers of clients in
treatment at the local level for
communities to assess capacity and
estimate resource requirements. This
information on substance use and
mental health services has assisted with
communities to better respond to life
changing events, (i.e., hurricane) and
plan for service demands in the event of
a natural disaster (i.e., earthquakes).
SAMHSA also maintains the
Inventory of Substance Use and Mental
Health Treatment Facilities (I–TF)
(previously known as the Inventory of
Behavioral Health Services [I–BHS]).
The I–TF is a master list of all known
substance use and mental health
treatment facilities in the United States.
It also serves as the universe population
for the N–SUMHSS.
SAMHSA is requesting OMB approval
of revisions to the N–SUMHSS and I–TF
related data collections, to include
changes to the following instruments:
N–SUMHSS Questionnaire
• Q1a: added to clarify if facilities
reported providing mental health
treatment services in Q1 also provide
substance use treatment services, to
help respondents understand how to
respond accurately and ensure
appropriate survey module(s) are
completed.
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]]>Agencies
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63589-63591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20029]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-4060]
Medical Devices With Indications Associated With Weight Loss
Guidances; Draft Guidances for Industry and Food and Drug
Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of two draft guidances entitled ``Medical Devices with
Indications Associated with Weight Loss--Clinical Study and Benefit-
Risk Considerations'' and ``Medical Devices with Indications Associated
with Weight Loss--Non-Clinical Recommendations.'' These draft guidance
documents provide recommendations regarding clinical study design for
devices with indications for use associated with weight loss, include
discussion on how FDA considers the benefit-risk analysis to support
such indications, and provide recommendations for the non-clinical
testing to support premarket submissions for these medical devices.
These draft guidances are not final nor are they for implementation at
this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 14, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance 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-2019-N-4060 for ``Medical Devices with Indications Associated with
Weight Loss--Clinical Study and Benefit-Risk Considerations'' and
``Medical Devices with Indications Associated with Weight Loss--Non-
Clinical Recommendations.'' 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.
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
[[Page 63590]]
``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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' or ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT: April Marrone, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2604, Silver Spring, MD 20993-0002, 240-402-6510.
SUPPLEMENTARY INFORMATION:
I. Background
These draft guidance documents provide recommendations regarding
clinical study design for devices with indications for use associated
with weight loss, include discussion on how FDA considers the benefit-
risk analysis to support such indications, and provide recommendations
for non-clinical testing to support premarket submissions for these
medical devices. These devices may be indicated for weight loss, weight
reduction, weight management, or obesity treatment in patients who are
overweight or have obesity. The recommendations and considerations
reflect current review practices and are intended to promote
consistency and facilitate efficient review of these submissions.
Prior to drafting these guidances, FDA requested public comment on
a concept for balancing the benefit of weight loss with the risks of
adverse events in a discussion paper (September 2019, Docket No. FDA-
2019-N-4060). FDA considered public comments and incorporated the
feedback as appropriate in developing the draft guidance, ``Medical
Devices with Indications Associated with Weight Loss--Clinical Study
and Benefit-Risk Considerations.''
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidance
documents, when finalized, will represent the current thinking of FDA
on ``Medical Devices with Indications Associated with Weight Loss--
Clinical Study and Benefit-Risk Considerations'' and ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations.'' They do not establish any rights for any person and
are not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Medical Devices with Indications
Associated with Weight Loss--Clinical Study and Benefit-Risk
Considerations (document number GUI00021016)'' or ``Medical Devices
with Indications Associated with Weight Loss--Non-Clinical
Recommendations (document number GUI00019046)'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E.................... Premarket 0910-0120
notification.
814, subparts A through E......... Premarket approval.. 0910-0231
812............................... Investigational 0910-0078
Device Exemption.
860, subpart D.................... De Novo 0910-0844
classification
process.
``Requests for Feedback and Q-Submissions and 0910-0756
Meetings for Medical Device Early Payor
Submissions: The Q-Submission Feedback Request
Program''. Programs for
Medical Devices.
800, 801, 809, and 830............ Medical Device 0910-0485
Labeling
Regulations; Unique
Device
Identification.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
50, 56............................ Protection of Human 0910-0130
Subjects: Informed
Consent;
Institutional
Review Boards.
58................................ Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical
Laboratory Studies.
------------------------------------------------------------------------
[[Page 63591]]
Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20029 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P
