Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient-Centric Value in Innovation; Public Workshop

摘要

The Food and Drug Administration (FDA) is announcing a public workshop entitled "Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward True Patient-Centric Value in Innovation." FDA is cosponsoring the workshop with the American Gastroenterological Association (AGA). The purpose of the workshop is to facilitate discussion between FDA, AGA, and other interested parties of the development of medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches for the regulation and reimbursement of minimally invasive procedures. The public workshop is being rescheduled due to the government shutdown. The title of the workshop has also been changed.