After months of withering criticism from industry regulators, Congress, and consumer advocates, FDA’s chief medical device regulator Daniel Schultz is resigning. Much of the criticism leveled at the medical device official has focused on his close relationship with medical device manufacturers. Two years ago during Congressional testimony, Senator Charles Grassley accused Schultz of ignoring science in favor of maintaining his cozy relationship with device companies.
During his tenure at the FDA, Schultz has at times sided with medical device makers over the safety objections of FDA regulators who’ve argued that the medical device in question raises serious health concerns. According to a Wall St. Journal report, “A group of nine device division employees wrote to the House Energy and Commerce Committee last October to complain that the division’s leaders had approved devices despite formal safety and efficacy concerns raised by FDA. They also alleged some scientists who objected to the decisions faced retaliation from leaders of the device division. The FDA at the time declined to comment.”
The resignation comes at a pivotal time for the medical device industry as the Senate is holding hearings on the Medical Device Safety Act of 2009 written to repeal the 2008 Supreme Court Riegel v. Medtronic decision. The medical device industry is also under increased scrutiny with lawsuits pending against manufacturers of defective medical devices such as Stryker and Zimmer hip implants and Medtronic’s Sprint Fidelis defibrillator leads.
Dr. Schultz has been the FDA’s chief medical device regulator for the past five years. FDA officials did not comment on how soon a replacement for Schultz would be made.