The Food and Drug Administration (FDA) recently announced the appointment of Michelle Tarver as the permanent director of the agency’s Center for Devices and Radiological Health (CDRH), a decision first reported by Stat and confirmed by MedTech Dive. Tarver, who previously held the position of acting director following the resignation of Jeff Shuren in July, brings a strong background in both the medical and regulatory fields to the leadership role.
FDA Commissioner Robert Califf praised Tarver’s appointment in an internal email, highlighting her dedication to data, science, medicine, and evidence-based approaches. He commended her efforts to foster collaboration and enhance transparency within the agency. Reflecting on her career, Tarver expressed pride in her more than 15-year tenure at the FDA, emphasizing a continued commitment to prioritizing the needs of the public.
Dr. Tarver, trained as an ophthalmologist with a doctorate in epidemiology, still actively treats patients with inflammatory eye conditions, adding practical healthcare experience to her administrative and regulatory roles. Prior to her latest appointment, she served as the CDRH’s chief transformation officer, where she was instrumental in launching strategic initiatives aimed at integrating patient perspectives more deeply into the medical device regulatory framework.
One of Tarver’s significant contributions was the establishment of the FDA’s first patient engagement advisory committee. This initiative underscored her focus on incorporating the voices and experiences of people living with medical conditions into device regulation and healthcare policy. According to Commissioner Califf, under her leadership, the CDRH initiated numerous projects that aimed to strengthen ties within the health care community and introduce innovative pathways for evidence generation.
Tarver’s commitment to listening to patients and incorporating their insights into regulatory processes was also a theme of her comments at The Medtech Conference the previous week. Although her permanent appointment had not been confirmed at that time, her interim leadership received strong support, with former director Jeff Shuren expressing confidence in her capabilities and hinting at a promising future under her guidance.
The medical technology industry has reacted positively to Tarver’s confirmation as director. Scott Whitaker, CEO of the trade group Advamed, lauded her unique combination of experience in medical practice, epidemiology, and regulatory affairs. He highlighted her understanding of the critical role that innovation plays in advancing healthcare, suggesting that her leadership could bring valuable advancements in medical technology, benefiting patients and providers alike.
In summary, Michelle Tarver’s appointment as the permanent director of the FDA’s Center for Devices and Radiological Health marks a significant milestone in her career and is poised to influence the future direction of device regulation and patient care in significant ways. With a robust background in both clinical care and regulatory oversight, Tarver is well-positioned to steer the CDRH towards greater innovation and deeper patient engagement in its regulatory processes.
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