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Medical Device Regulation Too Early to Assess European Union (EU) System's Valueas Model for FDA

机译：医疗器械监管过早评估欧盟（EU）系统的FDa的Valueas模型

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摘要

In 1993, the European Union (EU) began to implement a new system to regulatemedical devices--a system whose approach differs from that of the United States. Many critics of FDA have suggested that the new EU device review system offers a model that would enable innovative technology to reach U.S. consumers more quickly without increasing risks to the public's health. You asked us to examine both FDA's and the EU's device review systems. The objectives of our review were to (1) identify key differences between the U.S. and EU systems for reviewing medical devices; (2) compare outputs of the two systems, such as review time, if data were available; and (3) examine the feasibility of FDA's adopting features of the EU system. In preparing this report, we met with and analyzed data provided by FDA.

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