FDA regulation of medical devices. FDA perspective

In this article, based on a presentation before The Society of Thoracic Surgeons, D. Bruce Burlington, MD, director of the United States Food and Drug Administration's Center for Devices and Radiological Health, describes the role of the Center in regulating medical devices. Doctor Burlington discusses issues concerning investigational device exemptions and development of protocols, marketing review for new products, the use of guidance by the agency in developing products, and humanitarian device provisions. He focuses this discussion on circulatory support devices and therapies for cardiac patients. Throughout the discussion, Dr Burlington encourages manufacturers of new devices to discuss their plans and protocols with the agency before beginning their studies.