Regulation of drugs and devices: an evolution.

The U.S. Food and Drug Administration's (FDA's) drug approval process has evolved from a system in which a drug could lawfully be marketed unless the FDA were able to prove that the manufacturer knew that the drug would not work for the conditions for which it was promoted to one in which drug-makers require advance approval from the agency for almost every important step in testing, production, and marketing. The more modern system for regulating medical devices is the product of amendments to the federal Food, Drug, and Cosmetic Act in 1976. In those amendments, Congress sought to create a framework for control of device technology that would also facilitate innovation. This paper suggests that, notwithstanding this aspiration, both external pressures and internal practices are inexorably bringing device regulation closer to the "drug model."