The Food & Drug Administration made Jeffrey Shuren permanent director of its division overseeing the medical device industry, the Center for Devices and Radiological Health, according to the Reuters news service.
FDA commissioner Margaret Hamburg tapped Shuren as acting head of the division when his predecessor, Daniel Schultz, resigned in August, 2009, after a 15-year run at CDRH. Hamburg has made clear her intention to clean house at the troubled center, which has been dogged for years by charges that it’s too cozy with industry players and promising a faster-acting, more aggressive stance under her watch.
The FDA is also subjecting the CDRH to scrutiny from without and within. In addition to an internal investigation of its 510(k) clearance process — by which the majority of medical devices are approved — the federal watchdog agency commissioned the Institute of Medicine to conduct a $1.3 million, soup-to-nuts evaluation of the program.
Shuren has held various posts in Silver Springs, Md., since joining the FDA in 1998, according to Reuters. He was associate commissioner for policy and planning and oversaw development of Medicare’s national coverage decisions for medicines and non-implantable devices in another job.
