TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Tuesday, November 18, 2008

Congress Investigating FDA Medical Device Review Process

Ed Silverman reports that the House Energy and Commerce Committee is investigating allegations that managers at the FDA Center for Devices and Radiological Health have "corrupted and interfered with the scientific review of medical devices."

In a statement, John Dingell, who chairs the committee, and Bart Stupak, who chairs the Subcommittee on Oversight and Investigations, say they are probing allegations that the FDA “approved or cleared medical device applications in gross violation of laws and regulations….such activity could allow potentially unsafe and ineffective medical devices into the US market.”

More on the story at Pharmalot


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