Device Review Has Different Goals in United States and European Union

The U.S. and EU medical device regulatory systems share the goal of protecting public health, but the EU system has the additional goal of facilitating EU-wide trade. Another distinction between the two systems pertains to the criteria for reviewing devices. The U.S. medical device regulatory system exists within a public health context. In reviewing medical device applications FDA uses the two criteria mandated by law—safety and effectiveness. United States and EU Review Systems Structured Differently

The EU gives major regulatory responsibilities to public and private bodies; in contrast FDA has sole responsibility in the United States. Both systems link the level of medical device review to the degree of control needed to ensure device safety. However, the two systems use different procedures to reach approval or clearance decisions. Public Agencies and Private Notified Bodies Have Roles in EU Device Regulation

Governmental and private organizations both perform major functions in the EU system for regulating medical devices. EU Reviewers Subject to Less Comprehensive Conflict-of-Interest Rules Than FDA Reviewers

The EU medical device directives require the staff of NBs to be free of all pressures and inducements, particularly financial, that might influence their judgment or the results of their reviews, especially from anyone with an interest in the outcome of the review. Information Not Available to Compare Outcomes of New EU System and a Changing FDA

The EU medical device system is new and not yet fully operational. It is too early to evaluate the impact of those efforts on the length of FDA’s review process. At this time there are no data on the experience of the EU device review system that permit meaningful comparison with FDA.
Why GAO Did This Study

Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices, focusing on: (1) key differences between the two systems; (2) the outputs of the two systems; and (3) the feasibility of FDA adopting features of the EU system.

What GAO Found

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.