Monday, March 11, 1996
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