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Medical Devices / Regulatory Affairs

FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices

Sept. 20, 2019
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The FDA laid out its latest thinking on how it will handle risk-benefit reviews for weight-loss devices in a new discussion paper released ahead of planned draft guidance.

Weight-loss devices are an option for patients who have not responded to conservative medical interventions such as drugs, but who want an alternative to bariatric surgery, the agency said.

The FDA “continues to receive a high volume of pre-submissions from industry requesting feedback about the necessary data to support pivotal clinical studies and marketing applications for a wide variety of device designs intended for weight loss,” the agency said.

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