Understanding federal medical device statutes and their application to various penile prostheses

Medical devices have become an important component of our professional armamentarium. This paper exposes the practitioner to the Food and Drug Administration and its control over medical devices. Specifically, the 1976 amendment to the Food and Drug Administration Acts is described, along with the subsequent federal laws. Because of all the new technology available, physicians should be aware of the applicable laws and regulations. In addition, a review of the penile prosthesis includes its history and evolution, as well as the entire product line available for use. Attention is directed to the problems that have arisen from malfunctioning components.