The Associated Press has reported that Daniel Schultz, head of CDRH, is resigning his post. In a letter to agency staffers, Schultz said that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency,†according to the Associated Press.
Earlier this year, nine scientists wrote a letter to Obama’s transition team that alleged that the device approval process was corrupted. The letter, coupled with growing complaints about the 510(k) process, have led to increased scrutiny of CDRH methods. This month’s Washington Wrap-Up column takes a closer look at Schultz’s role in the process.
AdvaMed released the following statement after Schultz’s departure:
“Dan Schultz served the nation for more than 30 years promoting and protecting the public health as a member of the U.S. Public Health Service. Dan supervised FDA’s device center at time of unprecedented scientific advancement and helped continue U.S. leadership in the development of safe and effective medical treatments. As CDRH director, Dan was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees, which has provided FDA’s device program with a stable source of funding to help meet its regulatory responsibilities. In addition, he launched CDRH’s Postmarket Transformation Initiative, which is designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data. Dan also has been a leader in efforts to strengthen and harmonize global medical device regulatory requirements and has supported FDA’s work on the Global Harmonization Task Force. We wish Dan all the best in his future endeavors and look forward to working with Acting CDRH Director Jeff Shuren as the search for a permanent director of the device center proceeds.â€
[from DeviceTalk]
