Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at the FDA, is retiring.

Shuren became the acting director of CDRH in September 2009 and was appointed the permanent director in January 2010. During his tenure, he has implemented initiatives to modernize the regulation of medical devices through a total product life cycle approach to oversight and the organizational structure of CDRH.

According to Shuren, who announced his plans via email, he initially planned to retire in 2020 but chose to stay through the COVID-19 pandemic rather than leave during a crisis.

He will be handing the reins over to current deputy center director Michelle Tarver. The timing was chosen to allow Tarver full oversight of the upcoming Medical Device User Fee Amendment (MDUFA VI) negotiations. However, Shuren will remain at the FDA for a few months to help Tarver get settled in the new leadership role.

“Jeff understood the critical role a regulator plays in the innovation ecosystem, knowing how to balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and save lives,” said AdvaMed president and CEO Scott Whitaker, in a statement. “He saw AdvaMed and the medtech industry we represent as partners in addressing patients’ needs, and we hope his leadership serves as a model for all future directors of the CDRH.”

Tarver worked in CDRH’s Office of Surveillance and Biometrics and the Office of Device Evaluation before becoming deputy director of the office of strategic partnerships and technology innovation. Her role included oversight of disaster preparedness and response, digital health, conformity standards development, and transformative products. In July 2023, she became the deputy center director for transformation, where she has facilitated the development, implementation, and direction of transformative projects and initiatives.

Earlier this month, Shuren announced that the CDRH would be reorganizing to boost organizational agility, and advancing its public health mission. A key change involves elevating the Office of Communication and Education (OCE) to a Super Office, now named the Office of Communication, Information Disclosure, Training and Education (OCITE). This restructured office will include the Office of Communication and Content Development, the Office of Training and Education, and a new Division of Digital Communication and Marketing.

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