FDA In Brief: FDA solicits public feedback on discussion paper as part of efforts to provide clarity and transparency on how it evaluates benefits and risks of weight-loss devices

FDA In Brief: FDA solicits public feedback on discussion paper as part of efforts to provide clarity and transparency on how it evaluates benefits and risks of weight-loss 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 ...

Read More