The Safety Gap: Device Dangers -- Research Summary

Ivanhoe -- BACKGROUND: In several strongly worded letters, a group of nine FDA scientists complained of widespread managerial misconduct in the medical device division of the Food and Drug Administration. “The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA have been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the scientists wrote. The scientists go on to say that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

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