To familiarize medical providers with the Food and Drug Administration approval process for antiobesity devices and to provide a brief overview of current and promising endoscopy-based bariatric devices.
Literature review of published scholarly articles.
There has been a rapid development of novel endoscopic bariatric therapies in recent years, resulting in the approval of multiple devices. Several promising endoscopic strategies are currently under investigation and review. The Food and Drug Administration has laid down an objective-tiered model to review antiobesity device applications.
Endoscopic bariatric devices provide a new and promising paradigm in obesity management both as first-line therapy and as adjunctive treatment to medical and surgical strategies. Physicians who plan to offer endoscopic bariatric therapy in their practice need appropriate understanding of the regulatory processes involved in the development and approval of such devices.
1Division of Digestive Disease, University of California Los Angeles Health, Los Angeles, California, USA;
2Division of Gastroenterology and Hepatology, The Johns Hopkins Hospital, Baltimore, Maryland, USA;
3Division of Gastroenterology and Hepatology, University of Minnesota, Minneapolis, Minnesota, USA.
Received July 13, 2018
Accepted December 18, 2018