Regulation of Medical Devices

Abstract

The regulation of medical devices presents unique difficulties because of the breadth and complexity of the industry. Experts agree that increased federal control is essential to adequately protect the public, because of the serious loopholes in the Food and Drug Administration's cur rent premarketing controls. Over the years, a wide range of proposals for device legislation have been presented to Con gress, but none have gained any appreciable support from the lawmakers. The opposition of industry has been a major deterrent. Recent federal court decisions have strengthened FDA's hand in regulating devices under existing law and have lessened the manufacturers' objections to new legislation. Within this changed political framework, a consensus is developing in the Administration and on Capitol Hill for a new approach to device legislation, delegating many of the key decisions to non-government advisory groups. These groups would determine which devices needed premarketing clearance and what standards of safety and efficacy should apply. But it remains to be seen whether such substantial delegation of federal authority to non-government groups can be achieved without eroding the basic objective: consumer protection.