TORONTO — Michelle Tarver, acting director of the Food and Drug Administration’s medical device center, took the stage at the MedTech Conference on Thursday, setting the tone for the agency’s next chapter.
Tarver, who was named acting director in July after longtime leader Jeff Shuren retired, stressed the importance of putting people first as a regulator.
“When I did my residency in ophthalmology and I did a fellowship in ocular inflammation, I learned a really important lesson … the importance of pulling up a chair, sitting next to the people who are living with health conditions and letting them tell me their story,” Tarver said. The acting director of the FDA’s Center for Devices and Radiological Health is an ophthalmologist who holds a doctorate in epidemiology.
“I couldn’t figure out the diagnosis many times until I did that effectively, and I couldn’t tailor a treatment course unless I knew it was important to them and aligned the treatment recommendations with their values,” Tarver added.
Shuren, who was present at Thursday’s town hall discussion, said Tarver “will make an excellent center director, and quite frankly, the best is yet to come.”
The passing of the baton — though the FDA has made no official announcement — comes as Shuren is embroiled in controversy regarding his 15 years leading the CDRH. One month after retiring, The New York Times published an article raising concerns about potential conflicts of interest related to Shuren’s wife working as legal counsel for medtech companies during his tenure. The FDA has said it found no evidence the former director violated the criminal conflict of interest statute.
Shuren said at the event that “there’s a lot I’m personally proud of over my time at CDRH.” The crowd, which consisted largely of people who work in the medtech industry, gave Shuren a standing ovation and the report was not mentioned.
The CDRH has not yet appointed a permanent director. The application period closed on Aug. 27, FDA spokesperson Kristina Wieghmink told MedTech Dive, and the agency will announce its selection “after all the proper administrative steps.”
Before being named acting CDRH director, Tarver worked as the center’s chief transformation officer. Tarver has worked for the agency for 15 years.
Under Tarver’s leadership, the FDA created its first patient engagement advisory committee. More recently, Tarver started an initiative to consider people’s living environments in device design and clinical trial access, with the goal of improving health equity. The Home as a Health Care Hub program will start with diabetes devices, and use prototypes of apartments and small homes to help develop solutions that work for people who live there.
Tarver also shared an update on the agency’s progress for goals set in the most recent user fee agreement, saying the CDRH has met its hiring goals for fiscal years 2023 and 2024, and is “well on the way” for 2025.
The agency issued a draft guidance in September on patient preference information, or how to consider the value patients place on features of medical devices. Comments are open through December, and the FDA put a final guidance on its “under construction” list when it identified its priorities for fiscal 2025.
