Description
This draft guidance document provides the FDA’s recommendations regarding clinical study design for devices with indications for use associated with weight loss, and also includes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. Due to the wide variety of device designs, among other things, there can be variability in the demonstrated weight loss and risk associated with these devices. The recommendations reflect current review practices of premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests) for these devices and are intended to promote consistency and facilitate efficient review of these submissions.
Scope & Applicability
Product Classes
8The primary scope of the guidance document; Subject of the guidance document regarding clinical study considerations.
Example of an implantable device used for weight loss.
devices intended for significant weight loss
Intended to be used for a pre-determined, limited amount of time
Product code LTI, classified as a postamendments class III device.
Product code OYF, classified as a postamendments class III device.
Product code PIM, classified as a postamendments class III device.
Devices requiring explant considerations in study design; Device implanted without intention to remove
Stakeholders
3Independent committee to ensure safety of enrolled participants
advisory committee providing feedback on obesity devices
Analysis population including all randomized participants
Regulatory Context
Attributes
8Clinical performance testing considerations
A specific indication category for devices demonstrating significant long-term results.
One of the four weight loss indication categories defined in Table 5.
Defined as the total time the device is inside the body or the course of time used before measuring results.
long-term maintenance of weight loss
Study-wise control recommended for hypothesis testing in subgroups
Clinical performance testing considerations
expressed as kilograms of weight divided by height in meters squared (kg/m²); percentage change in body weight equals percentage change in BMI
Related CFR Sections (5)
- 21CFR860.7§ 860.7 Determination of safety and effectiveness.
(a) The classification panels, in reviewing evidence concerning the safety and effectiveness of a device and in preparing advice to the Commissioner, and the Commissioner, in making determinations concerning the safety and effectiveness of a device, will apply the rules in this section.Read full regulation →
- 21CFR860.3§ 860.3 Definitions.
For the purposes of this part:Read full regulation →
- 21CFR876.5981§ 876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
(a) Identification. An oral removable palatal space occupying device for weight management and/or weight loss is a prescription device that is worn during meals to limit bite size, thereby reducing the amount of food that is consumed. The device may contain recording sensors for monitoring patient uRead full regulation →
- 21CFR876.5982§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.
(a) Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.Read full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 345.200 Diaphragms - Rx Devices (Status: Final)
- CPG Sec. 398.200 Hazardous Diagnostic X-ray Systems (Status: Final)
- CPG Sec. 345.300 Menstrual Sponges (Status: Final)
- CPG Sec. 355.300 Ion Generating Devices (Status: Final)
- Guidance Document for the Preparation of IDEs for Spinal Systems - Guidance for Industry and/or FDA Staff (Status: Final)
- Guidance Document for Dura Substitute Devices - Guidance for Industry (Status: Final)
- Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery - Guidance for Industry (Status: Final)