Industry effects of medical device regulation: the case of diagnostic imaging equipment.

In 1976 Congress passed legislation authorizing the regulation of all medical devices. Some observers predicted that this regulation would have adverse effects on the newly regulated industries. This paper examines the major features of the medical device regulatory program and investigates how the regulation has affected the diagnostic imaging equipment industry. The results indicate that medical device regulation has not materially affected competition or innovation within established product classes in this industry. This suggests that, by choosing methods of regulation that differentiate among levels of potential risk to consumers, the goal of consumer protection can be achieved with fewer undesirable effects on the regulated industry.