FDA proposes new benefit-risk assessment for obesity devices

FDA proposed a benefit-risk assessment system for weight loss devices that would use available safety data for a device to set efficacy thresholds for a pivotal trial of that device. The proposal came in briefing documents issued to FDA's Gastroenterology and Urology Devices Panel ahead of a meeting on Thursday and Friday to discuss issues in the development of devices placed endoscopically or laparoscopically.

Devices would be classified into one of three risk levels based on the percent of patients who experience mild, intermediate and severe adverse events over one year. For example, to qualify for the lowest risk category, devices can have high rates of the most mild events (up to 100%), low rates of events of intermediate severity (2-5%), and very low rates of the more severe events (<0.1%). ...