FDA names new medical device chief

The FDA’s Center for Devices and Radiological Health (CDRH) confirmed the appointment of acting head Michelle Tarver, M.D., Ph.D. Tarver had held the interim position since late July, when Jeff Shuren, M.D., announced his retirement after 15 years.

Tarver, an ophthalmologist with a Ph.D. in epidemiology, has worked at the FDA since 2009. She has served in multiple positions at CDRH, including deputy director of the Office of Strategic Partnerships and Technology Innovation, program director of patient science and engagement, and deputy center director for transformation. As deputy director, she helped lead the center’s home as a health care hub program, which evaluates how certain medical devices will fit into people’s day-to-day lives.

Tarver told attendees of the MedTech Conference in Toronto last week that her goal is helping patients not just survive, but thrive. She also said health equity is a priority.

The appointment was positively received by AdvaMed, the industry group for medical device companies.

“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, in a statement. “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 health care. 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.”

According to the FDA, over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. She has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews.

Tarver received a B.S. in biochemistry from Spelman College in Atlanta and completed the M.D./Ph.D. program at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health. She continues to care for people living with inflammatory eye conditions.