FDA Seeking Input On New Risk Framework For Weight Loss Devices

By David Roza
September 10, 2019 at 6:15 PM
FDA is seeking public feedback on a new framework for evaluating the risks and benefits of weight loss devices such as intragastric balloons or other stomach implants. The framework comes amidst a surge of new weight loss devices and queries from industry, said FDA. The agency has approved nine such devices since 1985, six of which have been approved since 2015. The new framework, outlined in a discussion paper released Thursday (Sept. 5), uses a set of matrices that are...

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