An Overview of Food and Drug Administration Medical Device Legislation and Interplay with Current Medical Practices.

Abstract

Since the emergence of medical devices, legislation has been developed to allow the Federal Drug Administration (FDA) to oversee their development, marketing, and usage. This paper discusses the history of the FDA's involvement in medical devices, current approval processes, and several case examples. Additionally, it discusses both short- and long-term effects with unexpected consequences to U.S. health care delivery.