FDA Names Dr Michelle Tarver as New Chief of Medical Devices

Dr Tarver will oversee a division responsible for reviewing thousands of medical products, including diagnostic tools, surgical devices, and long-term implants such as pacemakers.

The US Food and Drug Administration (FDA) has named Dr Michelle Tarver as the new director of its medical device division.

Dr Tarver, a 15-year agency veteran, succeeds Dr Jeffrey Shuren, and takes on the role amid growing demands for improved safety standards and ethical governance in medical device approvals.

As the new head, Dr Tarver will oversee a division responsible for reviewing thousands of medical products, including diagnostic tools, surgical devices, and long-term implants such as pacemakers. The division operates with a budget of approximately $790 million and a workforce of around 2,500.

One of her key challenges will be addressing concerns about racial bias in artificial intelligence software and faulty cardiac devices, such as external defibrillators, while also managing the division’s involvement in emerging technologies such as brain-signal devices aimed at restoring speech and movement.

Dr Tarver’s appointment comes at a critical time as the agency seeks to restore credibility following the ethical controversies surrounding her predecessor.

Dr Shuren, who led the division for 15 years, was criticized for speeding approvals without sufficient safety checks. His tenure also raised concerns about potential conflicts of interest due to his wife's involvement with major medical device companies.

“I am honored to lead the division and remain committed to ensuring all patients in the U.S. have access to high-quality, safe, and effective medical devices,” Dr Tarver, an ophthalmologist and epidemiologist, said in a statement.

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