Medical Device Regulation: An Introduction for the Practicing Physician

Medical Device Regulation: An Introduction for the Practicing Physician

William H. Maisel, MD, MPH

From Brigham and Women's Hospital, Boston, Massachusetts.

Abstract

Patient care for the practicing physician increasingly relies on medical devices. The U.S. Food and Drug Administration is responsible for the safety and effectiveness of medical devices in the United States. In addition to playing a role in the clinical use of devices, physicians may also participate in their design, production, use, and safety by expressing their need for certain products, by providing practical input and feedback into product design, by participating in device-related research, and by reporting device-related adverse events. Physicians should understand the rules that govern the approved and unapproved use of medical devices as well as device premarket evaluation and approval processes and device postmarket surveillance.

Article and Author Information

Disclaimer: The opinions expressed in this paper are those of the author and do not necessarily reflect the opinion of the U.S. Food and Drug Administration.
Potential Financial Conflicts of Interest:Consultancies: U.S. Food and Drug Administration Center for Devices and Radiologic Health and Circulatory Systems Device Panel of the Medical Devices Advisory Committee.
Requests for Single Reprints: William H. Maisel, MD, MPH, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115; e-mail, wmaisel{at}partners.org.