Today, the U.S. Food and Drug Administration (FDA) issued a final guidance titled Medical Devices with Indications Associated with Weight Loss – Premarket Considerations.
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.
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