Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled "Medical Devices with Indications Associated with Weight Loss--Clinical Study and Benefit- Risk Considerations" and "Medical Devices with Indications Associated with Weight Loss--Non-Clinical Recommendations." These draft guidance documents provide recommendations regarding clinical study design for devices with indications for use associated with weight loss, include discussion on how FDA considers the benefit-risk analysis to support such indications, and provide recommendations for the non-clinical testing to support premarket submissions for these medical devices. These draft guidances are not final nor are they for implementation at this time.