CDRH Director Shuren to step down after 15 years
Michelle Tarver, deputy director for transformation, will serve as acting director of the FDA’s medical devices unit.
Jeff Shuren, who leads the Food and Drug Administration’s medical devices unit, will step down after 15 years as director.
Michelle Tarver, deputy director for transformation at the Center for Devices and Radiological Health, will become acting director of the group effective July 28, according to an email Tuesday from FDA Commissioner Robert Califf to staff, which an agency spokesperson shared with MedTech Dive.
Shuren, who is retiring from the FDA, will assist in the transition before leaving the agency later this year. The FDA will conduct a nationwide search for a permanent successor.
In a farewell message to agency colleagues, Shuren said the timing was right to step back this summer, before preparations begin for the next reauthorization of the Medical Device User Fee Amendments, and after the agency issued its final rule on laboratory developed tests.
“I have been here as the Center Director for a generation. That is a long time,” Shuren wrote. “I have been asked many times over the years ‘Why do you stay?’ Our public health mission and vision are important, exhilarating, and energizing. The work we do, while it has its frustrations and critics, is meaningful and rewarding.”
He called Tarver an “incredible leader” and expressed “full confidence” in the CDRH leadership team.
“She is the right person to take the helm,” Shuren said of Tarver, whom he hired as deputy center director. “She has my full support.”
In his message to the FDA staff, Califf said Shuren has been a “catalyst for the modernization of medical device regulation and innovator in every sense of the word.”
The number of medical devices authorized annually in the U.S. increased five-fold under Shuren’s leadership, Califf said. Shuren established the breakthrough devices program, which provides a faster FDA review of devices that can better treat or diagnose life-threatening or debilitating conditions. He also created CDRH’s first Digital Health Center of Excellence, which helped guide the agency’s approach to regulating digital health tools, and piloted the Total Product Life Cycle Advisory Program, where device companies can engage with the FDA earlier for devices of public health importance.
He also co-founded the International Medical Device Regulators Forum, a global standards group, and the Medical Device Innovation Consortium, a public-private partnership on regulatory science.
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“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,” Scott Whitaker, CEO of medical device lobbying group Advamed, said in a Tuesday statement.
Whitaker added that he looks forward to working with Tarver “to ensure the transition to new leadership is smooth, and that Dr. Shuren’s vision of a true public-private partnership remains the hallmark of the Center he helped establish as the gold standard for medical device safety worldwide.”
Tarver, who is a board-certified ophthalmologist, joined the FDA in 2009. As director of patient science and engagement, she built a program overseeing patient science development, policy work and patient engagement efforts, including CDRH’s first Patient Engagement Advisory Committee.
She later became deputy director of the Office of Strategic Partnerships and Technology Innovation, where she led efforts in emergency preparedness, digital health and standards development.
In her current role, Tarver is responsible for developing and implementing CDRH’s transformative projects and initiatives. For example, she recently launched the agency’s Home as a Health Care Hub initiative, which aims to address health disparities by considering people’s living spaces when designing medical devices and clinical trials.
Shuren said the agency’s next priority will be to develop its MDUFA reauthorization proposals and work with industry representatives and others on what recommendations should be submitted to Congress. The process of crafting MDUFA VI legislation will likely run into summer 2027, he said.
A Star Trek fan since childhood, Shuren compared the CDRH staff to the crew of the USS Enterprise.
“In work, as in life, we set a destination and a course, and when we, hopefully, arrive, we reach for new stars,” Shuren wrote, signing his farewell letter, “Kirk, out. Jeff.”