FDA Says Medical Device Reviews Must Be Streamlined

Law360, New York (July 20, 2011, 7:58 PM EDT) -- A U.S. Food and Drug Administration official told lawmakers Wednesday that the agency is working to improve its medical device review process in light of criticism that its overly burdensome regulations are severely delaying approval for innovative and necessary technology.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, acknowledged during a U.S. House of Representatives subcommittee hearing that the performance in his division has worsened in recent years due to a high rate of turnover and the increasing complexity of reviews....
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