Legal Status This site displays a prototype of a “Web 2.0” version of the daily
Federal Register. It is not an official legal edition of the Federal
Register, and does not replace the official print version or the official
electronic version on GPO’s govinfo.gov.

The documents posted on this site are XML renditions of published Federal
Register documents. Each document posted on the site includes a link to the
corresponding official PDF file on govinfo.gov. This prototype edition of the
daily Federal Register on FederalRegister.gov will remain an unofficial
informational resource until the Administrative Committee of the Federal
Register (ACFR) issues a regulation granting it official legal status.
For complete information about, and access to, our official publications
and services, go to About the Federal Register on NARA's archives.gov.

The OFR/GPO partnership is committed to presenting accurate and reliable
regulatory information on FederalRegister.gov with the objective of
establishing the XML-based Federal Register as an ACFR-sanctioned
publication in the future. While every effort has been made to ensure that
the material on FederalRegister.gov is accurately displayed, consistent with
the official SGML-based PDF version on govinfo.gov, those relying on it for
legal research should verify their results against an official edition of
the Federal Register. Until the ACFR grants it official status, the XML
rendition of the daily Federal Register on FederalRegister.gov does not
provide legal notice to the public or judicial notice to the courts.

Legal Status

Notice

You may be interested in this older document that published on 09/15/2023 with action 'Notice of availability.' View Document

Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability

A Notice by the Food and Drug Administration on 03/13/2026

• 1.

1.

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2019-N-4060 Document Citation 91 FR 12429 Document Number 2026-04918 Document Type Notice Pages 12429-12431
  (3 pages) Publication Date 03/13/2026 Published Content - Document Details

• PDF Official Content

  • View printed version (PDF) Official Content

• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2019-N-4060 Document Citation 91 FR 12429 Document Number 2026-04918 Document Type Notice Pages 12429-12431
  (3 pages) Publication Date 03/13/2026 Published Content - Document Details

• Document Dates Published Content - Document Dates Dates Text The announcement of the guidance is published in the Federal Register on March 13, 2026. Published Content - Document Dates

• Table of Contents Enhanced Content - Table of Contents This table of contents is a navigational tool, processed from the
  headings within the legal text of Federal Register documents.
  This repetition of headings to form internal navigation links
  has no substantive legal effect.

  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • ADDRESSES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • I. Background
  • II. Electronic Access
  • III. Paperwork Reduction Act of 1995 Enhanced Content - Table of Contents

• Related Documents Enhanced Content - Related Documents FederalRegister.gov uses the agency dockets published with the document to display related documents.

| Docket No. FDA-2019-N-4060
(2 Documents) | | | |
| --- | | | |
| Date | | Action | Title |
| | 2026-03-13 | Notice of availability. | Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability |
| | 2023-09-15 | Notice of availability. | Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability |

Enhanced Content - Related Documents

• Public Comments Enhanced Content - Public Comments Comments are no longer being accepted. See DATES for details.

Enhanced Content - Public Comments
- Regulations.gov Data Enhanced Content - Regulations.gov Data

FederalRegister.gov retrieves relevant information about this document
from Regulations.gov to provide users with additional context. This
information is not part of the official Federal Register document.

Consideration of Benefit-Risk Approaches for Weight-Loss Devices

Docket ID FDA-2019-N-4060 Supporting Documents Footnote 21 Dindo, Demartines and Clavien (2004) Classification of Surgical Complications A New Proposal With Evaluation... Footnote 9 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults re Discussion Paper:... Footnote 7 Ho et al (2015) Incorporating patient-preference evidence into regulatory decision making re Discussion Paper:... Footnotes 6 and 20 Lerner and Nipper (2013) Benefit-risk paradigm for clinical trial design of obesity devices: FDA... Footnote 1 Published Article Executive Summary re Discussion Paper: Consideration of Benefit-Risk Approaches for... Enhanced Content - Regulations.gov Data

- Sharing Enhanced Content - Sharing Shorter Document URL https://www.federalregister.gov/d/2026-04918 Email Email this document to a friend Enhanced Content - Sharing

• Print Enhanced Content - Print
  • Print this document Enhanced Content - Print
• Document Statistics Enhanced Content - Document Statistics Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day.

Page views 300
as of
03/14/2026 at 2:15 pm EDT Enhanced Content - Document Statistics
- Other Formats Enhanced Content - Other Formats This document is also available in the following formats:

JSON Normalized attributes and metadata XML Original full text XML MODS Government Publishing Office metadata More information and documentation can be found in our developer tools pages.

Enhanced Content - Other Formats
- Public Inspection Public Inspection This PDF is FR Doc. 2026-04918 as it appeared on Public Inspection on
03/12/2026 at 8:45 am.

It was viewed
158
times while on Public Inspection.

If you are using public inspection listings for legal research, you
should verify the contents of the documents against a final, official
edition of the Federal Register. Only official editions of the
Federal Register provide legal notice of publication to the public and judicial notice
to the courts under 44 U.S.C. 1503 & 1507. Learn more here.

Public Inspection
Published Document: 2026-04918 (91 FR 12429) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Document Headings Document headings vary by document type but may contain
the following:

1. the agency or agencies that issued and signed a document
2. the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to
3. the agency docket number / agency internal file number
4. the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details.

Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2019-N-4060]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Medical Devices with Indications Associated with ( printed 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 ( printed 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 CDRH-Guidance@fda.hhs.gov 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:

| 21 CFR Part or Guidance | Topic | OMB
Control No. |
| --- | --- | --- |
| 807, subpart E | Premarket notification | 0910-0120 |
| 814, subparts A through E | Premarket approval | 0910-0231 |
| 812 | Investigational Device Exemption | 0910-0078 |
| 860, subpart D | De Novo classification process | 0910-0844 |
| “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” | Q-submissions and Early Payor Feedback Request Programs for Medical Devices | 0910-0756 |
| 800, 801, 809, and 830 | Medical Device Labeling Regulations; Unique Device Identification | 0910-0485 |
| 820 | Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation | 0910-0073 |
| 50, 56 | Protection of Human Subjects and Institutional Review Boards | 0910-0130 |
| 58 | Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies | 0910-0119 |
Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

[FR Doc. 2026-04918 Filed 3-12-26; 8:45 am]

BILLING CODE 4164-01-P

Published Document: 2026-04918 (91 FR 12429)