In late 2008, a group of FDA scientists and physicians sent a whistleblower letter to Congress and the incoming Obama administration that has had far-reaching results on the medical device industry.
The group, which became known as The FDA Nine, alleged that in the medical device review process, managers at the Center for Devices and Radiological Health (CDRH) had "ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions, and recommendations in violation of the law.”
The six-page whistleblower letter alleged the following charges: scientists and doctors had been threatened and told, on occasion to ignore agency regulations; devices had not been properly labeled; managers without appropriate experience had been given authority to make final decisions about device regulation and had done so while ignoring serious safety and effectiveness concerns; agency experts
had been excluded from product meetings because managers felt they were biased; manufacturers had been allowed to market their products without FDA approval.
This letter, along with a follow up letter written in January 2009, brought congressional scrutiny that had a significant impact on the 510(k) review process and brought what the device industry largely perceived as negative changes to the 510(k) program.
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