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FDA Report Card 2015: Performance vs. EU Regulators

Performance vs. EU Regulators

For some period of time after enactment of the 1976 Amendments, the FDA was recognized as the 'Gold Standard' model for development, manufacture, and availability of state-of-the-art medical devices. The development and growth of the European regulatory system became a successful, perhaps more compatible, alternative to that of the FDA. As a result, many new device technologies are developed, investigated, and/or available in Europe before recognition by the FDA.

—Larry R. Pilot, attorney at law

FDA does a better job of regulating high-risk products than the EU, but the agency unfortunately does a poor job of regulating low-risk products. FDA tends to make it more difficult than it should be to bring low-risk products to market. In comparison, the EU has a much easier pathway for these low-risk products.

Bradley Merrill Thompson, shareholder, Epstein Becker & Green


It's difficult to do an apples-to-apples comparison, as both systems are fundamentally different. This is the way it should be. Having various regulatory bodies around the world creates a regulatory ‘check-and-balance’ system. It’s happened several times when one regulatory body makes the 'right' decision while another gets it wrong. If we wanted the EU and FDA to be the same, why not simply have one 'global' regulatory authority? Competition between companies creates the best products at the lowest cost. Is it any different for regulatory bodies?

—Michael Drues, PhD, president, Vascular Sciences 

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