Notice2023-20029
Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
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Published
September 15, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 These draft guidance documents provide recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how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.
Full Text
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<title>Federal Register, Volume 88 Issue 178 (Friday, September 15, 2023)</title>
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[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63589-63591]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-20029]
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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.
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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 These draft guidance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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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 <a href="/cdn-cgi/l/email-protection#347770667c1973415d50555a5751745250551a5c5c471a535b42"><span class="__cf_email__" data-cfemail="fcbfb8aeb4d1bb8995989d929f99bc9a989dd294948fd29b938a">[email protected]</span></a> 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:
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OMB control
21 CFR part or guidance Topic No.
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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.
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[[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
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