The FDA Nine: 10 People Who Changed the Medtech Industry

In late 2008, a group of FDA scientists and physicians sent a letter to congressman John Dingell (D-MI) alleging that in the device review process, “managers at CDRH have ordered, intimidated, and coerced FDA experts to modify their scientific reviews, conclusions, and recommendations in violation of the law.”

These scientists also wrote to then-president-elect Barack Obama in January 2009, noting that then-FDA-commissioner Andrew Von Eschenbach had conducted “a sham investigation” into their complaints about the compromised device review process and alleging “serious misconduct” and “shocking corruption” among FDA managers and CDRH leadership. They also alleged that managers retaliated against the scientists who did not follow their recommendations.

These letters and the resulting congressional scrutiny had a huge 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, who set about getting his house in order. 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 began to complain loudly that FDA was killing innovation, a charge that still reverberates today.

Despite that charge, the FDA Nine can be credited with providing some insight into the dynamics that govern the device review process. Perhaps for the first time, the public became aware that the same process was used to approve hip joints, power wheel chairs, catheters, and other seemingly low-risk devices.

The identities of the FDA scientists were redacted from the letters and never shared with the public. However, the de facto leader was Robert Smith, a radiologist at FDA who joined a few of his colleagues, including Paul T. Hardy and Ewa Czerska, to sue FDA for harassment and retaliation after they took their concerns public.