Food and Drug Administration's Perspective on Medical Devices Intended for Weight Loss: A Guide for the Interventional Radiologist.

ABSTRACT

Medical devices can help patients lose weight. The Food and Drug Administration (FDA) Center for Devices and Radiological Health is responsible for assuring the safety and effectiveness of devices used for weight loss. Interventional radiologists may conduct clinical studies of devices for weight loss, such as embolization beads to stop blood flow to gastric arteries or cryoablation systems to ablate metabolism-linked nerves. The purposes of this paper are (1) to clarify the FDA's role providing regulatory oversight of clinical studies of medical devices; (2) to explain how to engage with the FDA; and (3) to provide information on the design of clinical studies intended to support a weight loss indication. In particular, Investigational Device Exemptions (IDEs) are needed for significant risk studies for new devices, or for off-label use of legally marketed devices. The FDA is available through the Pre-Submission process to assist when determining if a study requires an IDE, and to discuss plans for submitting an IDE. The FDA works with medical device manufacturers and clinical researchers who want to bring novel weight-loss devices to market.