Jeff Shuren stabilized the FDA’s medical devices center, winning over industry but not all patients

Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July, the device world was stunned. Industry leaders, patient advocates, and FDA colleagues alike had grown accustomed to the ambitious, politically-savvy regulator.

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

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Shuren landed at the Center for Devices and Radiological Health after serving in various policy roles in the commissioner’s office, with stints as an FDA detailee on the Senate health committee and as a director at the Centers for Medicare and Medicaid Services. All in all, he’s worked in the government for 28 years.

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