On July 23, 2024, Dr. Jeff Shuren, the director for the Center for Devices and Radiological Health (CDRH), announced that he will retire. Dr. Shuren became director of the CDRH in 2009. As director of the CDRH, Dr. Shuren oversaw the approval of medical devices and monitoring of radiation-emitting products. He implemented several programs, including the Breakthrough Devices Program and National Evaluation System for health Technology (NEST). During Dr. Shuren’s tenure, the CDRH become more efficient. Approval of medical devices has increased five-fold. Importantly, the CDRH also approves between 50 and 70 percent of novel devices in the United States before, or in parallel, with other countries, giving American patients access to life-changing technologies earlier. FDA Comissioner Robert Califf described Dr. Shuren as “a catalyst for the modernization of medical device regulation and innovator in every sense of the word.” AdvaMed President and CEO Scott Whitaker also praised Dr. Shuren, noting Dr. Shuren’s ability to “balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and save lives.”
Dr. Shuren announced that Dr. Michelle Tarver will take over as acting director of the CDRH on July 28th. Dr. Tarver was hand-picked by Dr. Shuren to join the CDRH in 2009 and currently serves as the Deputy Center Director of Transformation. Dr. Tarver’s work at the FDA has focused on patient engagement. Dr. Tarver leads the Patient Engagement Advisory Committee and worked on the FDA’s Home as a Health Care Hub initiative. Dr. Tarver will continue to pursue the CDRH’s strategic priorities of (1) promoting a diverse workforce, (2) enhancing organizational agility, and (3) advancing health equity.