News

FDA Appoints New Medical Devices Chief Amid Calls for Enhanced Safety Oversight

• By John K. Waters
• 11/02/2024

The U.S. Food and Drug Administration (FDA) has appointed Dr. Michelle Tarver as permanent director of its Center for Devices and Radiological Health (CDRH). A 15-year veteran of the FDA's medical device division, Tarver is an ophthalmologist who continues to treat patients on weekends. As the new director of the department, she is expected to bring a renewed focus on patient safety to a division historically criticized for prioritizing rapid device approvals.

Tarver's new role comes with significant responsibilities, including addressing growing concerns over the safety of artificial intelligence (AI) tools used in healthcare and faulty cardiac devices. She will also be tasked with restoring public trust in a division tainted by past ethical controversies, including issues surrounding her predecessor,  Jeffrey Shuren.

Under  Shuren, the FDA accelerated the approval of many medical devices, positioning the U.S. as a leader in medical innovation but drawing criticism over safety standards. Investigations have raised concerns about potential conflicts of interest tied to  Shuren's professional overlap with his wife, a lawyer for medical device companies, leading to recent calls for an internal review by the Health and Human Services inspector general.

In accepting the role, Tarver emphasized her commitment to public health and to ensuring access to high-quality medical devices for patients nationwide. "Our mission is to protect public health while promoting safe and effective medical technologies," Tarver said in a statement.

Tarver brings both medical and epidemiological expertise to the role, having previously worked in the FDA’s emergency preparedness and digital health initiatives. Her appointment has received broad support from patient advocacy groups and industry representatives alike. Maria Gmitro, president of the Breast Implant Safety Alliance, praised Tarver’s collaborative approach, citing her work to enhance transparency on safety data for breast implants.

Scott Whitaker, president of AdvaMed, the industry’s largest trade association, expressed confidence in Tarver’s ability to balance safety with innovation, saying the organization welcomes her "collaborative approach and understanding of the need to bring proven technologies to those who need them."

Tarver will also be tasked with addressing concerns from patients affected by LASIK surgery, a sector she has overseen for years. Despite longstanding calls to tighten safety warnings on the procedure, the FDA has yet to implement such measures, a delay attributed by critics to industry influence.

"Dr. Tarver is a visionary leader who believes in the power of collaboration to improve patient care," said Andrew C. Fish, President and CEO of the Medical Device Innovation Consortium (MDIC), in a statement.  "Her support for incorporating patient needs and perspectives, improving quality manufacturing, and advancing regulatory evidence development will be foundational to our continued work with Dr. Tarver in her new role as CDRH Director."

As Tarver steps into the position, she must navigate a complex landscape of rapid technological advances, regulatory scrutiny, and industry partnerships. The FDA’s medical device division, with an annual budget of $790 million and a staff of about 2,500, reviews a wide range of products, including DNA tests, pacemakers, and brain-interface technologies aimed at restoring lost neurological functions.

Tarver’s appointment marks a potential shift for the FDA toward a stronger emphasis on patient safety, a move watched closely by advocates and industry players alike.