FDA Holds Meeting on Medical Device Approval

David Mittleman

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In a rare move, the U.S. Food and Drug Administration (FDA) is conducting an "all-hands" meeting to discuss concerns regarding its medical device division. The meeting, set to happen today, is the first such gathering in years.

The division of the FDA responsible for approving medical devices has come under heavy fire in recent months. In January, nine agency scientists authored a letter to then-President-elect Obama in which they accused the FDA of mismanagement, lack of accountability, and even possible corruption. Also in January, the Government Accountability Office released a report criticizing the FDA for lacksidasical regulation of high-risk Class III medical devices. In addition to its questionable approval process, the agency has evidently permitted healthcare facilities to wash and reuse equipment intended to be used only once.

According to the scientists who wrote the letter, the FDA is "fundamentally broken" and honest employees at the agency face intimidation from dishonest employees. As a result of the FDA’s shortcomings, the scientists claim that the agency is "placing the American people at risk."