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# Groups Question FDA Weight Loss Paper
- URL: https://www.fdaweb.com/groups-question-fda-weight-loss-paper/
- Published: 2019-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:55:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145667

The Obesity Action Coalition and American Society for Metabolic and Bariatric Surgery say an FDA discussion paper on benefit/risk approaches for weight loss medical devices may not recognize that treating the chronic disease of obesity requires a full continuum of care. The groups’ comment [letter](https://www.regulations.gov/document?D=FDA-2019-N-4060-0013&ref=fdaweb.com) says that discussion paper use of language quantifying weight loss treatment as short-term or long-term when applied to devices might not reflect real-world care. The groups also say the agency should consider using a staging system to differentiate care for those who are well versus those who are sick.

In their [letter](https://www.regulations.gov/document?D=FDA-2019-N-4060-0012&ref=fdaweb.com), the Association for Bariatric Endoscopy, the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy say a statement in the discussion paper could be interpreted to mean that FDA will require sponsors to perform randomized controlled trials with a sham control arm when this is possible. “Comparing open-label and sham-controlled studies with the same categorization scheme is problematic,” the groups say. They recommend that the proposed benefit categorization should only be used if all future studies are open-label.