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GUIDANCE DOCUMENT

Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations Draft Guidance for Industry and Food and Drug Administration Staff September 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-N-4060
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations for the non-clinical testing to support premarket submissions (e.g., Premarket Approval (PMA) Applications,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) for medical devices with indications for use associated with weight loss. 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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-N-4060.

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