FDA의 감량 목적 의료기기에 대한 관점: 간섭성 방사선의학자 가이드

초록

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