The U.S. Food and Drug Administration (FDA) announced the appointment of Dr. Michelle Tarver as the new director of its Center for Devices and Radiological Health on Tuesday. This leadership change comes during a transformative period in the medical device industry, particularly with the rising influence of artificial intelligence (AI) in medical technologies.

Dr. Tarver succeeds Dr. Jeffrey Shuren, who retired in July after 15 years of overseeing the agency amid scrutiny for ethical lapses and close ties to the medical device industry. FDA Commissioner Dr. Robert Califf expressed confidence in Tarver's abilities, stating, "Dr. Tarver demonstrates a true passion for data, science, medicine, and evidence, all of which are critical to supporting and driving the FDA’s decisions." He noted her commitment to fostering collaboration and transparency in achieving the agency's strategic priorities.

In her statement, Tarver expressed her honor in leading the division and reiterated her dedication to public health, emphasizing the importance of ensuring that all patients in the U.S. have access to high-quality, safe, and effective medical devices.

The FDA's medical device division manages a budget of $790 million and employs over 2,500 staff members, overseeing the development of thousands of devices that are essential for medical diagnosis and treatment. This includes both longstanding products like hip replacements and coronary stents, as well as innovative devices incorporating advanced technologies, including AI.

Dr. Tarver is described in her FDA biography as a "visionary public health executive," board-certified in ophthalmology, and holding a doctorate in epidemiology. With more than 15 years of experience as a medical device regulator, she has led strategic initiatives, conducted clinical research, and contributed to changing organizational culture within the agency.

Her educational background includes a Bachelor of Science in Biochemistry from Spelman College and an M.D./Ph.D. from the Johns Hopkins University School of Medicine and Bloomberg School of Public Health. Notably, Dr. Tarver remains active in clinical practice, caring for patients with inflammatory eye conditions.

Reactions to her appointment have been largely positive. Scott Whitaker, president of AdvaMed—the largest medical device industry trade association—praised Tarver's collaborative approach and her commitment to delivering safe, proven technologies to patients and providers. Diane Zuckerman, president of the National Center for Health Research, commended Tarver for her focus on patient safety and her efforts to ensure that patients are well-informed about the risks and benefits of medical devices.

As Dr. Tarver steps into this pivotal role, her leadership is expected to influence the future of medical device regulation and innovation in the United States.