Shuren Named Director of the CDRH
BY LAUREN UZDIENSKI, JANUARY 25, 2010
Jeffrey Shuren, M.D. has been named director of the CDRH. He has served as acting director since Dan Schultz resigned in August of 2009, stating at the time that he aimed to review the 510(k) pathway, establish predictable regulatory pathways for new technologies and create internal conflict resolution procedures. From his permanent post he'll have the time to accomplish these goals, though it's unknown now what shape these new policies will take.
Shuren takes the reins at CDRH at a time where device safety and the legitimacy of FDA regulatory pathways are at the forefront. Dan Schultz (who has since joined regulatory consulting firm Greenleaf Health) left amid concerns over ReGen Biologics' 510(k) clearance for Menaflex, which is currently being reviewed again after an internal investigation found certain deviations from procedure. The FDA called the Menaflex case a "definite threat" to their process.
Shuren said recently that no major changes were imminent for the 510(k) process, though the pathway is the subject of ongoing review. On Feburary 18th, the agency will hold a public meeting on the 510(k), and they intend to discuss issues related to "predicate devices"; "new technologies and scientific evidence"; "practices the FDA has adopted in response to a high volume of submissions"; and "postmarket surveillance and new information about marketed devices."
As noted in the press release announcing his appointment, Shuren has a decade-long history at the FDA, where he was instrumental in a number of prominent initiatives. These include negotiating for the reauthorization of the Medical Device User Fee Act and aiding in the creation of the Sentinel Initiative, an electronic device-reporting platform. He has also held posts at CMS.
