FDA Guidance on Medical Devices for Weight Loss

Detected March 13th, 2026

Summary

The FDA has issued guidance for medical devices intended for weight loss, outlining recommendations for non-clinical testing and clinical study design to support premarket submissions. This guidance aims to promote consistency and facilitate efficient review of submissions for devices related to weight loss, reduction, management, or obesity treatment.

View original document View source feed page

What changed

The FDA's Center for Devices and Radiological Health has released new guidance (Docket Number: FDA-2019-N-4060) detailing recommendations for non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss. This guidance applies to various premarket submissions, including PMA, IDE, 510(k), and De Novo requests, and discusses how the FDA considers benefit-risk analysis for such devices. The document aims to standardize review practices for devices intended for weight loss, weight reduction, weight management, or obesity treatment.

While this guidance is non-binding, medical device manufacturers seeking approval for weight loss-related indications should review and incorporate these recommendations into their premarket submission strategies. The guidance provides a framework for demonstrating the safety and effectiveness of these devices, which can vary significantly in design, demonstrated weight loss, and associated risks. The FDA accepts comments on this guidance at any time, with the docket number FDA-2019-N-4060 to be used for all submissions.

What to do next

Review FDA guidance on premarket considerations for medical devices with weight loss indications.
Incorporate recommended non-clinical testing and clinical study designs into relevant premarket submissions.
Ensure benefit-risk analysis is adequately supported for devices targeting weight loss, reduction, management, or obesity treatment.

Source document (simplified)

Search for FDA
Guidance Documents

Docket Number: FDA-2019-N-4060 Issued by: Guidance Issuing Office Center for Devices and Radiological Health This guidance document provides the FDA’s recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions (e.g., Premarket Approval (PMA) Applications, Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo classification requests). 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. 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, as well as variability in the applicability of some of the recommended testing. 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.