Review of procedures for investigational device exemptions

This critique of the proposed FDA "Device Exemptions" (1978, Docket 76N-0324) analyses its defects, estimates the magnitude of device injury to patients during past 17 years, provides a prescription for rational FDA regulation under the present law, which is summarized and shown to allow FDA wide latitude in regulatory pressure; emphasizes the urgent need for properly trained engineers, which are not presently in or available to FDA; and estimates and predicts vast cost increases, competition suppression and blockade of new devices. The classification schema is shown to be illogical and capricious; the economic impact assessment faulty; and the law, extant regulations, proposed regulations complicated, confusing, and internally inconsistent.