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. Shuren dramatically increased the number of medical devices authorized by the FDA each year — by five-fold, according to Commissioner Rob Califf’s email announcing the news.
More recently, Shuren pushed forward a controversial rule to actively regulate lab-developed tests, taking matters into his own hands after Congress failed to pass a bill explicitly giving the FDA this authority. Lab groups have already sued the FDA over this rule, and its fate remains uncertain, especially with the Supreme Court overturning the Chevron doctrine and making federal rules vulnerable.
