Regulation of devices: a quickening pace

The Medical Device Amendments of 1976 erected the framework for the most complete regulatory scheme administered by the Food and Drug Administration. The FDA has fulfilled its charge to establish investigational device exemption regulations, recordkeeping requirements, and informal hearing procedures. The author concludes that (a) technological innovation will come in a climate of step-by-step FDS involvement, (b) recordkeeping requirements will be focused to maximize the agency's power to take regulatory action, and (c) the hearing mechanism for judging many significant agency regulatory actions will be in the hands of FDA employees who will be free to operate with almost no rules of evidence to constrain them.