The law on cardiovascular devices: the role of the Food and Drug Administration and physicians in its implementation.

Abstract

The Medical Device Amendments of 1976 gave the Food and Drug Administration (FDA) new authority to regulate all medical devices. This regulation requires that manufacturers provide data supporting the safety and effectiveness of new and modified devices before marketing them, and eventually provide similar data even for devices now on the market. Those working in the cardiovascular field use a device every day of their professional lives; therefore, the Medical Device Amendments will have a significant effect on everyone in the field. We must understand the law so that we can provide scientific guidance to the FDA and to the medical device industry; in this article we aim to provide the necessary information.