Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead.
Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips pulled millions of respiratory machines, and scrutiny of its former leader’s potential conflicts of interest.
Patient advocates, who have called for stronger device standards and faster, more transparent recalls, see an opportunity for change with a new director. Meanwhile, medtech companies hope to build on predecessor Jeff Shuren’s legacy of making the U.S. the go-to market for new medical devices.
“She is in a position to show a commitment to public health and safety, and possibly build that trust and confidence in the public for medical devices,” said Maria Gmitro, founder and president of the Breast Implant Safety Alliance, a nonprofit advocacy group.
Tarver’s leadership
Tarver was named permanent director last week after spending more than 15 years with CDRH. Some of her accomplishments include helping build the first patient engagement advisory committee at the FDA, developing patient-reported outcome measures, and conducting trials and surveys to capture patient preferences.
Both patient groups and device companies commended Tarver’s experience and focus on patients, describing her as thoughtful and approachable.
“She let it be known that she cared very much about patients understanding the risks and benefits of medical products, and including patients and consumer advocates in the process,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank.
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