The U.S. Food and Drug Administration (FDA) has released its Final Guidance on pre-market submission considerations for medical devices intended for uses associated with weight loss.
The Final Guidance, titled “Medical Devices with Indications Associated with Weight Loss-Premarket Considerations,” provides developers seeking the FDA’s premarket approval for devices associated with weight loss with detailed recommendations regarding non-clinical testing and clinical study design, as well as information on how the agency considers benefit-risk analysis of data generated from testing and design.
Specific products addressed in the Guidance include intragastric implants, aspiration therapy systems, and neuromodulators.
As a reminder, FDA guidance documents do not establish legally enforceable requirements or responsibilities and are simply intended to reflect the agency’s current thinking on a given subject. Nonetheless, guidance documents can be extremely helpful to manufacturers and developers seeking FDA review of their medical devices.
The FDA’s Final Guidance on premarket considerations for medical devices intended for uses associated with weight loss is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-devices-indications-associated-weight-loss-premarket-considerations.