Medical device regulation: an introduction for the practicing physician

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.