[Federal Register Volume 91, Number 49 (Friday, March 13, 2026)]
[Notices]
[Pages 12429-12431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-04918]
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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--
Premarket Considerations; Guidance 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 a final guidance entitled ``Medical Devices with
Indications Associated with
[[Page 12430]]
Weight Loss--Premarket Considerations.'' This guidance document
provides recommendations regarding non-clinical testing and clinical
study design for medical devices with indications for use associated
with weight loss to support premarket submissions. The guidance also
includes discussion on how FDA considers the benefit-risk analysis to
support such indications.
DATES: The announcement of the guidance is published in the Federal
Register on March 13, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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--Premarket Considerations.'' 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 ``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 guidance document entitled
``Medical Devices with Indications Associated with Weight Loss--
Premarket Considerations'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6353.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document provides recommendations regarding non-
clinical testing and clinical study design for medical devices with
indications for use associated with weight loss to support premarket
submissions. The guidance also includes discussion on how FDA considers
the benefit-risk analysis to support such indications. Examples of
indications associated with weight loss include indications for weight
loss, weight reduction, weight management, or obesity treatment in
patients who are overweight or have obesity. The recommendations
reflect current review practices of premarket submissions for these
devices and are intended to promote consistency and facilitate
efficient review of these submissions.
Prior to issuing this guidance, 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.''
A notice of availability of the draft guidances ``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'' appeared in
the Federal Register of September 15, 2023 (88 FR 63589). FDA combined
the two draft guidances into one final guidance document for ease of
use, since the scope of the draft guidances included the same device
area. FDA also considered comments received and revised the language as
appropriate in response to the comments. Edits to the final guidance
include clarification on the use of sham controls, discussion of
[[Page 12431]]
statistical analysis using modified intent-to-treat populations,
inclusion of patient-reported outcomes as a factor to be considered as
part of the benefit-risk evaluation, provision of additional reference
citations, and addition of references to FDA's Q-Submission Program,
which can be used to request feedback on aspects of a proposed clinical
study design.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). This guidance represents the
current thinking of FDA on ``Medical Devices with Indications
Associated with Weight Loss--Premarket Considerations''. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
FDA considered the applicability of Executive Order 14192, per
Office of Management and Budget (OMB) guidance in M-25-20, and finds
this action to be neither an E.O. 14192 regulatory nor an E.O. 14192
deregulatory action.
II. Electronic Access
Persons interested in obtaining a copy of the 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 and at 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--Premarket Considerations'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number GUI00019046 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 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 notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
800, 801, 809, and 830......... Medical Device Labeling 0910-0485
Regulations; Unique
Device Identification.
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
50, 56......................... Protection of Human 0910-0130
Subjects and
Institutional Review
Boards.
58............................. Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical Laboratory
Studies.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-04918 Filed 3-12-26; 8:45 am]
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