Scientific Publications by FDA Staff

Gastrointest Endosc Clin N Am 2017 Apr;27(2):327-41

The regulatory perspectives on endoscopic devices for obesity.

Marrone AK, Antonino MJ, Silverstein JS, Betz MW, Venkataraman-Rao P, Golding M, Cordray D, Cooper JW

The recent increase in US Food and Drug Administration-approved weight-loss devices has diversified obesity treatment options. The regulatory pathways for endoscopically placed weight-loss devices and considerations for clinical trials are discussed, including the benefit-risk paradigm intended to aid in weight-loss-device trial development. Also discussed is the benefit-risk analysis of recently approved endoscopic devices. A strategic priority of the FDA Center for Devices and Radiological Health is to increase the use of patient input in decision making. Thus, we consider how endoscopic weight-loss devices with profiles similar to those that have been approved may be viewed in a patient preference study.