Medical Device Regulation

The European Union's (EU) system for regulating medical devices is not only new--it is not yet fully in place. Therefore, it is too early to evaluate its success in ensuring the safety of medical devices and bringing them to market efficiently. Because the major players in the EU system have not had enough time to establish a track record, it will be some time before important questions about the new system can be answered. U.S. government officials who want to consider integrating features of the EU approach into the U.S. device review system will be better able to judge the merits of the EU system after it has been in operation for several years. The U.S. medical device industry has urged giving private third parties a role in the review of medical devices, and the Food and Drug Administration is exploring this possibility in a pilot project. Ensuring that private reviewers were independent, had the requisite expertise, and had sufficient resources would strengthen the confidence of Congress and the public in the integrity of the device review process. Such assurances would carry even more weight if private review organizations were given the added authority to clear new devices for marketing.

GAO found that: (1) U.S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system is designed to facilitate EU-wide trade; (2) while EU reviews medical devices for safety and performance, FDA reviews devices for safety, effectiveness, and benefit to patients; (3) while EU gives major medical device regulatory responsibilities to public agencies and private organizations, FDA has sole responsibility over device regulation in the United States; (4) both systems link the level of medical review to device risk, but the two systems use different procedures to reach approval or clearance decisions; (5) questions and concerns have arisen regarding possible conflicts-of-interest in the EU medical device review process because EU notified bodies carry out a regulatory function within the EU medical device system and conflict-of-interest rules for EU reviewers are less comprehensive than in the United States; (6) sufficient data does not exist on the EU medical device review system to permit meaningful comparison with FDA because the EU system is new and not yet fully operational; and (7) it is too early to evaluate the impact of new FDA streamlined review procedures.