Perspective:

Patients worldwide currently depend on an expanding array of medical devices for the diagnosis and management of disease. A review of device approval in the United States and Europe shows that both systems are facing problems requiring policy changes. The greatest challenge facing US device regulation is the evaluation of high-risk devices through pathways intended for lower-risk devices, such as the 510(k) process. In such cases, one solution is reliance on postmarket surveillance to ensure that devices are closely monitored when they are approved, perhaps with automatic review of clinical experiences after a period of years to ensure that the devices are operating as intended and producing the expected benefits. The European Union system, on the other hand, may be improved with better coordination and centralization to ensure consistent interpretation of directives at the level of a central body and to assist understaffed competent authorities in monitoring device safety. Key problems in the European Union are the near-total lack of empirical evidence regarding the performance of its system and the lack of public access to either premarket or postmarket data. Ultimately, systems for approving new medical devices must provide pathways to market for important innovations while ensuring that patients are adequately protected.