September 5, 2019
“Obesity is a major public health epidemic in the U.S. and is associated with many health problems such as heart disease, diabetes and stroke. Having a variety of weight-loss treatment options available, including devices, increases the number of patients who could benefit from therapy,” said William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “As innovators conceive and develop the next generation of weight-loss devices for U.S. consumers, the FDA is looking to provide greater clarity on how we consider risk in light of varying degrees of benefits that these devices may provide. In a discussion paper issued by the agency today, we outline a concept that the FDA is considering for inclusion in a forthcoming draft guidance on the assessment of risks and benefits of weight-loss devices. This discussion paper continues the FDA’s efforts to be transparent and informative about how we regulate these devices.”
The U.S. Food and Drug Administration today issued a discussion paper on assessing risk for weight-loss devices with varying degrees of benefits. The FDA has actively engaged stakeholders regarding how we can best ensure patients have access to safe and effective devices intended for weight loss.
The concepts discussed in this paper focus on how to consider the extent of weight loss in relation to the extent of adverse events for weight-loss devices. This assessment would be considered along with other factors as part of the FDA’s benefit-risk assessment of a new weight-loss device submitted to the agency for premarket review.
The FDA is seeking public feedback on proposed benefit categories outlined in its discussion paper, how to best classify adverse events and whether Evaluation Matrices (a potential additional decision aid for use by FDA staff) may be beneficial to systematically compare benefits and risks for devices intended for weight loss.
The FDA will consider public comments to the concept for weight-loss devices for the development of a draft guidance. This discussion paper is not draft or final guidance and is not intended to propose or implement policy changes regarding the benefit-risk of weight-loss devices.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.