Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry, saying she’ll “make an excellent center director, and quite frankly, the best is yet to come.”
This week, the agency made it official.
The Center for Devices and Radiological Health (CDRH) confirmed the appointment Tuesday. Tarver had held the interim position since late July, when Shuren announced his retirement after 15 years in the post and moved into the role of center director emeritus.
An ophthalmologist by training with a Ph.D. in epidemiology, Tarver has worked at the FDA since 2009. She has held multiple leadership positions at CDRH, including deputy director of the Office of Strategic Partnerships and Technology Innovation, and program director of patient science and engagement.
Most recently, her title was deputy center director for transformation, where she helped lead the center’s strategic initiatives—including the FDA’s home as a healthcare hub program, which aims to help evaluate how certain medical devices will fit into people’s day-to-day lives.
At the MedTech Conference hosted by AdvaMed last week in Toronto, Tarver reintroduced herself to the industry during an FDA town hall and laid out her leadership vision for the center—describing her approach as mission-driven, with the goal of helping patients “not merely to survive, but to thrive, and to do so with some compassion, some passion, some humor and some style.”
Tarver also named advancing health equity as a priority and discussed how the agency aims to address patient preferences in how they interact with health systems as well as disparities in access to care.
In a statement this week, the medtech association AdvaMed said it welcomed the choice.
“Over her time as an ophthalmologist, epidemiologist, and medical device regulator, Dr. Tarver has made clear she understands the value of medical technology and the important role innovation plays in our health care system,” said AdvaMed President and CEO Scott Whitaker. “We’re confident she’ll lead CDRH with a collaborative approach and an appreciation for the need to get safe, proven technologies into the hands of the patients and providers who need them.”
Peter Arduini, president and CEO of GE HealthCare and chair of AdvaMed’s board of directors, added: “AdvaMed members look forward to working with Dr. Tarver and her team at CDRH as the FDA continues its work to improve patient care through its rigorous medical device review process.”
“The FDA has an especially difficult task ahead as AI plays an increasingly critical role in healthcare,” Arduini said. “Ensuring the review process for these technologies is clear and consistent will be paramount. AdvaMed and industry stand ready to work with FDA to ensure safe and effective lifesaving technologies are brought to market.”