The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.
Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.
She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.
In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.
The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.
A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.
Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.
Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.
An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.
In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”
Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.
At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.
Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.
Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.
Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.
“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”
Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.
In a letter announcing his retirement to staff in July, Dr. Shuren said he took the “unusual step” of appointing Dr. Tarver to the division’s post of deputy director for transformation without conducting a formal search. In that role, she has worked on a project called Home as a Health Care Hub that is meant to support an aging population with mounting medical needs.
“She is truly wonderful as a person, a colleague, a friend and a leader,” Dr. Shuren said in his letter. “She is the right person to take the helm.”
Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.
Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.
The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.
“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”
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