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.

CDRH's then-director Dan Schultz resigned and was replaced by Jeffrey Shuren. Stung by congressional and media scrutiny, reviewers began to ask more questions about applications, delaying what was once considered a fast-track process. And the medical device industry griped that FDA was killing innovation.

Nevertheless, The FDA Nine can be credited with providing some insight into the dynamics that govern the device review process.

The whistleblower group later filed a lawsuit in 2012 claiming that the agency monitored their private email accounts, which they accessed using FDA computers and sent through government networks, in retaliation of their whistleblowing activities. That lawsuit, however, was tossed out by a federal judge in Washington in 2014 because the group had not exhausted all other administrative avenues of redress within the agency.

Check back next week for a new Trivia Tuesday question on our home page and test your knowledge about the medical device and diagnostics industry!