Tarver named new CDRH director

Michelle Tarver has been named the new permanent director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), nearly three months after being named acting director after former CDRH head Jeff Shuren announced he would vacate the position. The trained ophthalmologist has been crucial in the agency’s ongoing efforts to ensure equity in medical product development and its efforts to focus on advancing healthcare solutions in the home.

On 22 October, FDA Commissioner Robert Califf sent an agency-wide email announcing Tarver's appointment as permanent director of its device center. He noted that Tarver also has a doctorate in epidemiology and has served in various leadership positions at the agency over the past 15 years. (RELATED: Shuren to leave FDA after 15 years as CDRH director, Regulatory Focus 23 July 2024)

“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,” said Califf. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

“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,” he added. “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.”

Before stepping into her current position, Tarver served as CDRH deputy center director for transformation and deputy director of the Office of Strategic Partnerships and Technology Innovation. She started her career at FDA as a staff fellow and went on to serve as a medical officer in CDRH’s Office of Surveillance and Biometrics, Division of Epidemiology.

Tarver has a bachelor's degree in biochemistry from Spelman College in Atlanta and an MD/PhD from Johns Hopkins University School of Medicine and the Bloomberg School of Public Health. She has experience conducting clinical trials and surveys and has continued to practice as an ophthalmologist.

Tarver also issued a statement following the announcement expressing her commitment to public health.

“As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission,” she said. “As we embark on CDRH’s next chapter, we remain committed in our service to public health and ensuring all patients in the US have access to high-quality, safe and effective medical devices.”

Since taking on the role of acting director of CDRH, there have been indications that Tarver would be appointed as the permanent center director. During a CDRH town hall at the 2024 Medtech Conference in Toronto last week, Shuren reflected on his time at the center and praised Tarver and other colleagues for their work.

“I’m very proud of Michelle, she’ll make an excellent center director, and quite frankly, the best is yet to come,” he said.

During the same event, Tarver detailed her vision for the center and outlined her leadership style.

“I want to share with you some of the principles that drive how I work and how I lead,” Tarver said. “The first is that I am insatiably curious … Taking a risk, and asking why and why not is critical to who I am.”

Tarver further stated that collaboration is another principle that drives her. She noted that regardless of all the hats she has worn at CDRH, she has not done it alone and believes in tapping into “the collective brain power” to get things done.

Finally, Tarver said she is mission-driven and paraphrased the American poet Maya Angelou.

“My mission is not merely to survive but to thrive, and to do so with some compassion, some passion, some humor and some style,” she said. “I think that’s really important because the mission is what drives me to stay at FDA for more than 15 years. It’s putting people first.”

Tarver highlighted three strategic priorities that CDRH has focused on over the past few years that she plans to continue working on, including promoting a modern and diverse workforce, enhancing organizational agility and resilience, and advancing health equity. The agency is currently working on finalizing its guidance on clinical trial diversity action plans and has been talking with stakeholders on how to improve health equity. (RELATED: Diversity action plans: Stakeholders seek clarity on demographic data, enrollment, and global trials, Regulatory Focus 3 October 2024)

"It is critically important that no person is left behind in healthcare and that we create solutions that meet the needs of the US public,” she said.

During another panel at the Medtech Conference, Tarver said that health equity is important to her personally because when delivering her daughter, the pulse oximeter used to monitor her oxygen levels failed to work effectively. As a result, she suffered respiratory depression, and she had to be admitted into the intensive care unit.

"I've got all the resources available to me, my husband was a spine surgeon, we knew the anesthesiologist personally, and it didn't work for me,” she said. “It goes to show it's not about economics; it's about other features.”

Tarver said it's important for FDA and other stakeholders to ask whether a product will work for all the people it is intended for.

"Thankfully, I had a good outcome, but not everybody does,” she added. “That's why it's important to the agency."

In addition to her work to improve health equity in regulatory decisions at FDA, she has also been instrumental in developing CDRH’s Health Care at Home Initiative, which was launched in April. (RELATED: Stakeholders seek guidance, clarity from FDA on at-home medical technologies, Regulatory Focus 12 September 2023)

After FDA’s announcement, AdvaMed CEO Scott Whitaker offered his congratulations.

“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,” he said. “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.”

Steven Grossman, executive director at the Alliance for a Stronger FDA, also praised her appointment.

“Dr. Tarver is a respected veteran leader within the FDA and will be a worthy successor to Dr. Shuren," he said. "In particular, we expect her to continue the Center’s innovative approaches to regulation and its commitment to stay ahead of the curve in the increasingly complex world of medtech.”

Tarver named new CDRH director

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