Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.

Healthcare DIVE November 4, 2024
Elise Reuter

Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former director Jeff Shuren’s leadership.

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead.

Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips pulled millions of respiratory machines, and scrutiny of its former leader’s potential conflicts of interest.

Patient advocates, who have called for stronger device standards and faster, more transparent recalls, see an opportunity for change with a new director. Meanwhile,...

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