GAO doesn't yet buy into European model

WASHINGTON - The General Accounting Office (GAO) last week released a report on medical device regulation that questions the applicability of using the European regulatory system as a model for FDA reform.

The report, which was requested by Senate Labor and Human Resources Chairman Nancy Kassebaum, states that it is too early to assess the European medical device regulatory system's value as a model for reform. Proponents of FDA reform have pointed to the EU system, which relies much more on manufacturers' voluntary compliance with guidelines and less on formal approvals procedures, as a model for future U.S. practice. ...