Medical devices as medical problems: the regulation of devices for clinical use.

The development of statutes to regulate the safety and efficacy of medical devices has been proceeding rapidly. The protection of the consumer from dangerous and ineffective devices is obviously necessary and must be carried out rapidly and efficiently. The electrical shock hazard in prevalence and violence is a case in point. There is no question that many devices are not well made and not suited for the function for which they are sold. These must be controlled, but at the same time we must be careful not to destroy the private research and development efforts which are producing reliable instrumentation through over control and regulation.