Jeff Shuren, the longstanding director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), announced his decision to retire after a remarkable 15-year tenure. His departure is scheduled for later this year, with the transition of leadership beginning on July 28. Michelle Tarver, currently the deputy director for transformation at CDRH, is set to take over as the acting director. FDA Commissioner Robert Califf communicated this leadership change in an email to the staff, which highlights the significant contributions Shuren has made during his time at the helm.
Throughout his career at the FDA, Shuren has played a crucial role in advancing the regulation of medical devices, a sector that has seen substantial innovation and growth. Under his direction, the CDRH witnessed a five-fold increase in the annual authorization of medical devices in the U.S. Shuren was instrumental in the establishment of several key programs and initiatives which have shaped the landscape of medical device regulation. These include founding the breakthrough devices program, which expedites the review process for critical life-saving or life-altering devices, and initiating the FDA’s first Digital Health Center of Excellence. This center guides the regulatory framework surrounding emerging digital health technologies.
Additionally, Shuren helped to pilot the Total Product Life Cycle Advisory Program, allowing device companies to engage with the FDA earlier in the development process for crucial public health devices. His vision extended internationally as he co-founded the International Medical Device Regulators Forum, a global consortium setting standards in the industry, and the Medical Device Innovation Consortium, a notable public-private partnership focused on regulatory science.
As Shuren prepares to step down, he has expressed full confidence in Michelle Tarver to lead the CDRH. Tarver, who was personally hired by Shuren as the deputy center director, has a robust background in both clinical practice as a board-certified ophthalmologist and in various strategic roles within the FDA. Since joining the agency in 2009, she has spearheaded significant projects including the development of the Patient Engagement Advisory Committee and leading efforts in digital health and emergency preparedness. Tarver’s current responsibilities involve steering CDRH’s transformative initiatives, such as the Home as a Health Care Hub initiative which aims to integrate considerations of patients’ living environments into device design and clinical trials.
The leadership change comes at a pivotal time as the FDA gears up for the reauthorization of the Medical Device User Fee Amendments (MDUFA). Shuren emphasized the importance of this timing in his farewell message to the agency, noting that stepping back now allows the new leadership to shape the forthcoming negotiations and proposals essential to the MDUFA reauthorization process. He reflected on his long tenure with a sense of achievement and purpose, driven by the FDA’s mission to protect public health. Shuren described his years at the FDA as rewarding and underscored the significance of the work done by the agency despite its challenges and criticisms.
Shuren’s departure tributes included commendations from industry leaders, including Scott Whitaker, CEO of the medical device lobbying group Advamed. Whitaker acknowledged Shuren’s critical role in fostering innovation while ensuring device safety and effectiveness. He also noted that he looks forward to working with Tarver to maintain the standard of excellence established under Shuren’s leadership.
As the FDA continues its crucial work in medical device regulation, Shuren leaves behind a legacy of significant improvements in both the process and standards governing medical devices. His farewell note drew from his enthusiasm for Star Trek, likening the CDRH team to the crew of the USS Enterprise—a metaphor for their ongoing mission to explore new frontiers in medical technology. As Shuren signs off, “Kirk, out,” his leadership era at the FDA will be remembered for its substantial impact on public health and medical innovation.
#CDRH #Director #Shuren #step #years
