Medical device development: innovation versus regulation.
Innovation in the development of medical devices has been an important factor in the practive of health care in the United States. However, in a climate of increasing federal regulation, concern is expressed that such regulation can inhibit scientific creativity in the medical device industry. Several examples of the impact of increasing regulation in the discovery and development of new drugs are presented. Increasing regulation will divert research dollars from discovery efforts to regulatory maintenance. Surgeons can participate in the regulatory process by informing the public and the government on issues regarding safety and effectiveness of medical devices.
D004864:Equipment and Supplies / Q000592:standards*; D006077:Government Agencies; D006350:Heart Valve Prosthesis; D006801:Humans; D012106:Research; D014481:United States; D014486:United States Food and Drug Administration