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# FDA Wants Weight Loss Device Feedback
- URL: https://www.fdaweb.com/fda-wants-weight-loss-device-feedback/
- Published: 2019-09-05T12:00:00.000Z
- Updated: 2026-09-15T01:48:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144931

FDA says it is seeking feedback for 90 days on a discussion paper about a concept that the agency is considering to aid in assessing tolerability of risk in light of varying degrees of benefit for medical devices intended for weight loss. The paper [says](https://www.regulations.gov/searchResults?rpp=25&po=0&s=fda-2019-N-4060&fp=true&ns=true&ref=fdaweb.com) so far CDRH has approved nine devices through PMAs for weight loss. It says the agency 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.

CDRH says the concepts in the paper focus on how to consider the extent of weight loss in relation to the extent of adverse events for weight-loss devices. That 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.

Feedback is sought on the proposed benefit categories outlined in the paper, how to best classify adverse events, and whether evaluation matrices may be beneficial to systematically compare benefits and risks for devices intended for weight loss.