GUIDANCE DOCUMENT
Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations Draft Guidance for Industry and Food and Drug Administration Staff September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2019-N-4060
- Docket Number:
- FDA-2019-N-4060
- Issued by:
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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document provides the FDA’s recommendations regarding clinical study design for devices with indications for use associated with weight loss, and also includes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.