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’s email to staff, chock-full of Star Trek references, reflected on his 15-year journey leading the agency’s Center for Devices and Radiological Health. He acknowledged the difficulty of the decision, but said he has his “own new worlds still to explore.” In addition to informing staff in an email, he made personal calls to people in the device industry on Tuesday. It is not yet clear where Shuren will go after leaving the FDA.
Shuren, who spent 28 years in federal government, started his FDA career in the commissioner’s office in 1998. He became director of the devices center in 2009 and has served in that position ever since. During 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 Robert Califf’s email announcing the news.
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