FDA Names New CDRH Director

It’s official: Dr. Michelle Tarver will lead the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). 

Dr. Tarver had been named acting CDRH director in the wake of her predecessor’s retirement announcement this past summer. Jeff Shuren had worked at the FDA for 28 years, serving in various roles culminating in CDRH director in 2010 and then moving into the role of center director emeritus. 

The FDA did not issue an official statement on Dr. Tarver’s appointment but the CDRH confirmed the change in title, according to published reports. A board-certified ophthalmologist, Tarver has worked at the FDA since 2009 and 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. She most recently worked as the deputy center director for Transformation, steering the development, implementation, and direction of CDRH’s projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the health care ecosystem, and stimulate creative evidence generation pathways.  

“We’re pleased by this news. 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,” AdvaMed President/CEO Scott Whitaker said in a formal 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.”
 
Dr. Tarver  he has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture. During 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. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. 
 
Dr. Tarver earned a bachelor of science degree in biochemistry from Spelman College in Atlanta, a doctorate in epidemiology, 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. 
 
“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,” commented Peter J. Arduini, GE Healthcare president/CEO and chair of AdvaMed’s Board of Directors “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.”