Jeff Shuren, medical devices head at FDA, to leave the agency
Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email reviewed by STAT.
Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998. He became director of the Center for Devices and Radiological Health in 2009 and has served in that position ever since. Under his tenure, he created the breakthrough devices program, a pathway that has become immensely popular for device makers seeking expedited approval and reimbursement. He dramatically increased the number of medical device authorized by the FDA each year — by five-fold, according to Commissioner Rob Califf’s email announcing the news.
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