Medical Devices With Indications Associated With Weight Loss-Premarket Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Medical Devices with Indications Associated with Weight Loss--Premarket Considerations." This guidance document provides recommendations regarding non-clinical testing and clinical study design for medical devices with indications for use associated with weight loss to support premarket submissions. The guidance also includes discussion on how FDA considers the benefit-risk analysis to support such indications.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.