Consideration of Benefit-Risk Approaches for Weight-Loss Devices

Consideration of Benefit-Risk Approaches for Weight-Loss Devices

Weight-Loss Devices: FDA Seeks Comments on New Discussion Paper

Today the U.S. Food and Drug Administration (FDA) published a discussion paper, Consideration of Benefit-Risk Approaches for Weight-Loss Devices. The discussion paper describes a concept the FDA is considering to assess the safety and effectiveness of weight-loss devices and highlights areas where the FDA seeks input from stakeholders.

Read the Discussion Paper The FDA is accepting comments for 90 days at Regulations.gov under docket number FDA-2019-N-4060. Submit Comments Questions? If you have questions about weight-loss devices, contact the Division of Industry and Consumer Education (DICE).