USA – Weight-Loss Devices: FDA Seeks Feedback on Benefit-Risk Considerations

Ahead of a planned draft guidance on assessing the benefits and risks of new weight-loss devices, the US Food and Drug Administration (FDA) on Thursday circulated a discussion paper to gather feedback on some of concepts the agency is considering for the guidance.

“Obesity is a major public health epidemic in the US 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, director of the Office of Product Evaluation and Quality within the Center for Devices and Radiological Health.

Specifically, FDA says it is looking for input on the proposed benefit categories outlined in the 14-page discussion paper, as well as feedback on adverse event classification and whether evaluation matrices may be useful to compare benefits and risks for weight-loss devices.

“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 FDA’s benefit-risk assessment of a new weight-loss device submitted to the agency for premarket review,” FDA writes…