Regulation of Human Tissue for Transplantation

Abstract

Historically the Food and Drug Administration has not regulated human tissues for transplantation, but with the pervasive scourge of AIDS and widespread public concern about preventing its transmission, pressure has mounted on the government to introduce more specific regulatory controls over the tissue industry. This paper will document the development since 1990 of the movement to achieve such controls, by examining Congressional legislation, FDA activity, testimony of important figures involved in the debate, and industry trends.