US devices centre falls under scrutiny of Congress, “gross violations” alleged

An investigation has been launched into allegations that managers within the FDA’s Center for Devices and Radiological Health (CDRH) corrupted and interfered with the scientific review of medical devices.

Congressmen John Dingell, chairman of the House committee on energy and commerce, and Bart Stupak, chairman of the subcommittee on oversight and investigations, launched the investigation on November 17 after receiving a letter containing the allegations.

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