According to a report published on Bloomberg.com, scientists and physicians at the Food & Drug Administration (FDA) have charged that the agency has corrupted the process by which new medical devices are approved.

The names of scientists who made the charges, as well as the devices to which they refer, have been redacted in the copy of a letter released to the public.

But the allegations in the letter are troubling. The scientists charge that misconduct by managers at the FDA Center for Devices and Radiological Health (CDRH) “is interfering with our responsibility to ensure the safety and effectiveness of medical devices for the American public and with FDA’s mission to protect and promote the health of all Americans.”

The letter was sent to members of the House Energy and Commerce Committee, the Congressional arm that provides oversight of the FDA.

This entry was posted on Wednesday, November 19th, 2008 at 3:06 pm and is filed under Medical Device. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.