medical device, a product defined by the U.S. Food and Drug Administration that includes a wide variety of implants, instruments, and other items that affect structure and function but are not metabolized within or on the body. A medical device must also be recognized in the official National Formulary or the United States Pharmacopoeia. Medical devices are subject to regulation by the FDA. There is a clear distinction between a medical device and drugs, which are subject to a different set of regulations.
