BY LAUREN UZDIENSKI, AUGUST 13, 2009
FDA’s director of the Center for Devices and Radiological Health, Dr. Daniel Schultz, is resigning his post following a “mutual agreement” with FDA commissioner Margaret Hamburg.
The news follows complaints from critics that Schultz’s oversight of the device industry may have been too lax. One example is ReGen Biologics, where Schultz reportedly championed the company’s Menaflex device for market clearance despite the objections of certain FDA scientists. In May, the FDA announced that they would review the Menaflex clearance process.
In a statement, AdvaMed president and CEO Stephen Ubl praised Schultz for his contributions to the reauthorization of MDUFMA in 2007 as well as his role in the CDRH’s Postmarket Transformation Initiative, described by Ubl as “designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data.”
Schultz served as CDRH director since 2004 and worked at the FDA for 15 years. The agency’s associate commissioner, Jeff Shuren, will serve as acting CDRH director until Schultz’s replacement is named.
source: www.healthpointcapital.com
