The FDA announcement comes about three months after Dr. Jeff Shuren stepped down as head of CDRH after 15 years as medtech’s top regulator — with plans to retire by the end of the year. At the time, Tarver, an agency veteran who was most recently deputy center director for transformation, took over as acting director.
Tarver is board-certified in ophthalmology and has a doctorate in epidemiology. She has an MD and PhD from The Johns Hopkins University School of Medicine and the Bloomberg School of Public Health. In her more than 15 years as a medical device regulator, she moved up the ranks at the FDA, including time as the director of CDRH’s Patient Science and Engagement office. As director of Patient Science and Engagement, she established and built the program that oversees patient science development and policy work and patient engagement efforts, including the Patient Engagement Advisory Committee.
Announcing Tarver’s appointment as permanent CDRH director, FDA Commissioner Dr. Robert M. Califf praised Tarver for demonstrating a true passion for data, science, medicine, and evidence.
“She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency,” Califf said. “She has a strong understanding of the medical product ecosystem, with a solid grasp of how digital solutions and other types of innovation are helping to shape health care. To this end, she works effectively to help keep the FDA ahead of the curve by applying these technologies in ways that ensure safety, support and guide industry, and provide optimal opportunities for patients and consumers.”
In a statement shared by an FDA spokesperson, Tarver said she is immensely proud of the work already accomplished. “As we embark on CDRH’s next chapter, we 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.”
Medtech trade group AdvaMed was positive about the news that Tarver is now officially CDRH director.
“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. 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,” AdvaMed CEO Scott Whitaker said in a news release.
GE HealthCare CEO Pete Arduini, who is AdvaMed’s board chair, added: “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.”