How Jeff Shuren Ensured Stability of the FDA’s Medical Device Center

RResignations from the Food and Drug Administration aren’t exactly shocking, especially in the face of pandemic burnout. But when longtime medical device executive Jeff Shuren announced his departure in July, the device world was stunned. Industry leaders, patient advocates and FDA colleagues had grown accustomed to an ambitious, politically minded regulator.

“It’s hard to imagine the FDA without him,” said Yale cardiologist and health outcomes researcher Harlan Krumholz. “He’s been the face of CDRH forever.”

Shuren came to the Center for Devices and Radiological Health after serving in various policy roles in the commissioner’s office, with stints as FDA on the Senate Health Committee and as director of the Centers for Medicare and Medicaid Services. He has served in government for 28 years.