• Posted October 23, 2024

FDA Appoints New Head of Medical Devices

The U.S. Food and Drug Administration announced Tuesday that it has appointed Dr. Michelle Tarver to head its division that oversees medical devices.

The appointment of a new director for the Center for Devices and Radiological Health comes at a time of great innovation and change in the medical device field, with AI playing an increasing role in medical technologies.

Tarver replaces outgoing director Dr. Jeffrey Shuren, who faced criticism over ethical lapses during his 15 years of running of an agency with close ties to the medical devices industry. Shuren announced his retirement in July.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the FDA’s decisions,” FDA Commissioner Dr. Robert Califf said in an announcement to agency staff, the New York Times reported. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

According to the Times, the FDA's medical device division has a budget of $790 million and a staff of over 2,500 people. It oversees the development of thousands of devices used in medical diagnosis and treatment.

These devices include items that have been around for decades, such as hip replacements and coronary stents, as well as cutting-edge devices that are utilizing technologies such as AI.

Her FDA bio describers Tarver as "a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology....She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research and changing organizational culture."

"Dr. 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," the bio goes on to say. "As a dedicated clinician, she continues to care for people living with inflammatory eye conditions."

Reaction to Tarver's appointment was generally positive.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said in a statement that Tarver will lead the division "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.”

Diane Zuckerman is president of the National Center for Health Research, a nonprofit that monitors FDA device policy. Speaking to the Times, she said she said Tarver is focused on patient safety and “in making sure that patients understand the risks and benefits” of medical devices.

SOURCES: U.S. Food and Drug Administration, website; AdvaMed, news release, Oct. 22, 2024; New York Times