Panel Debates Risk Categorization, Surveys for Weight Loss Devices

Makers of low-risk weight loss devices may be able to test them on less obese patients if the FDA heeds recommendations made by its Gastroenterology and Urology Devices Panel. While low-risk devices may produce only a moderate amount of weight loss, they might help patients avoid the kind of weight gain that would lead to a higher body mass index (BMI) and possibly the need for more invasive procedures, the panel said. For that reason, clinical trials in patients with lower BMIs should be allowed, the panel said.
Devices & Diagnostics Letter