Shuren to leave FDA after 15 years as CDRH director

After almost 15 years as director of the Center for Devices and Radiological Health (CDRH), Jeff Shuren announced he will leave the US Food and Drug Administration (FDA) later this year. Starting next week, Michelle Tarver, deputy center director for transformation, will take on the role of CDRH acting director.

During a CDRH all-hands meeting on 23 July, Shuren announced his plan to retire from the US Food and Drug Administration (FDA). On 28 July, he plans to transfer to the commissioner’s office as center director emeritus to allow Tarver to take the reins and the center transition to a new permanent center director.

Shuren told staff he had achieved several key goals over the years, which led him to consider leaving the agency in 2020. He noted that since he took the reins in 2009, new medical devices authorized in the US increased five-fold, and between 50 and 70 percent of novel devices come to the US or in parallel with other major markets. However, his plans were thwarted when the COVID-19 pandemic hit.

“I have been considering this decision for several months in order to think it through, plan it out, and finish some actions I needed to see to the end, such as issuing our final regulation on laboratory developed tests,” said Shuren during the meeting. “Back in 2018 I thought we would achieve our vision by the end of 2020, or thereabouts, and that then would be a good time for me to depart. However, COVID-19 hit, and we had a job to do.”

“As you well know because you were there with me, too, we cannot abandon our posts in a time of crisis,” he added. “Today, the pandemic is in our rearview mirror, our Center is not only back on track, but I think better positioned and stronger than ever before, and our current vision has been achieved.”

Under his leadership, Shuren noted that FDA had launched its Breakthrough Devices Program, Patient Science and Engagement Program, established the Digital Health Center of Excellence (DHCoE), created the National Evaluation System for health Technology (NEST), co-founded the International Medical Device Regulators Forum, and helped establish the Medical Device Innovation Consortium (MDIC). He has also represented FDA during the last three Medical Device User Fee (MDUFA) negotiations and noted now was the right time to hand over the reins so that the new negotiations can be helmed under new leadership.

“In the coming months we will begin to develop our proposals for the next reauthorization of the Medical Device User Fee Amendments (MDUFA), then enter into discussions with industry representatives and others about what recommendations for reauthorization should be submitted to Congress, followed by legislation – a process that will likely run into the summer of 2027,” said Shuren. “As with prior reauthorization discussions, our mission and vision will be our North Star and inform our proposals for MDUFA VI.”

Despite his achievements, Shuren will leave several key efforts on the table for his successors to take up, including premarket review reform and fully implementing the Total Product Lifecycle Advisory Program (TAP). During the MDUFA V negotiations, FDA was only able to persuade the medical device industry to support a TAP pilot to assess its viability before committing to it more fully, and in recent years he has advocated for a Voluntary Alternative Pathway (VAP) which has yet to come to fruition.

FDA Commissioner Robert Califf issued an agency-wide email soon after saying he had “mixed emotions” about Shuren’s decision to leave the agency after 28 years.

“As CDRH Director since 2009, Jeff has been a catalyst for the modernization of medical device regulation and innovator in every sense of the word,” said the commissioner. “He has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as Director. Jeff’s accomplishments are varied and far too many to recount here.”

Califf also welcomed Tarver, who was hand-picked by Shuren to join the agency in 2009, to her new position as acting CDRH director. He highlighted her work at FDA, especially her work to give patients a voice through CDRH's Patient Engagement Advisory Committee (PEAC).

Michelle Tarver, CDRH chief transformation officer, spoke at the 2023 Medtech Conference on 9 Oct. (Source: Ferdous Al-Faruque)

Michelle Tarver, CDRH chief transformation officer, spoke at the 2023 Medtech Conference (Source: Ferdous Al-Faruque)

"In her current role as Deputy Center Director of Transformation, Michelle facilitates the development, implementation and direction of CDRH’s transformative projects and initiatives, including Home as a Health Care Hub," said Califf. "Michelle has led a number of cross-cutting initiatives, fostered strategic collaborations, published many peer-reviewed papers and received numerous awards for her work, including the CDRH Award of Merit and the American Academy of Ophthalmology Secretariat Award."

“Please join me in extending immense appreciation to Jeff for his distinguished tenure at the FDA and warmly welcoming Dr.Michelle Tarver to her new role starting next week,” he added.

AdvaMed CEO Scott Whitaker, thanked Shuren for his service and said his member companies looked forward to working with Tarver.

"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 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."

"His willingness to work with us to support next-generation innovation, and his strategic vision for the Center have been critical to allowing medtech innovators to do what they do best. We wish him all the best in the next phase of his life and career," he added.

Shuren to leave FDA after 15 years as CDRH director

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