Jeffrey Shuren, a key figure in the regulation of medical devices at the U.S. Food and Drug Administration (FDA), recently announced his decision to step down from his position, ending a tenure of 28 years at the agency. Shuren, who began his career at the FDA in 1998 within the Commissioner’s Office, later ascended to the role of director of the Center for Devices and Radiological Internships in 2009. It is a capacity in which he has served effectively till his recent announcement.
Throughout his stint at the FDA, one of Shuren’s notable achievements was the creation of the breakthrough devices program. This program, highly favored among device makers, offers a streamlined process for the expedited approval and reimbursement of medical devices. Under Shuren’s leadership, there was a reported five-fold increase in the number of medical devices authorized by the FDA annually, a statistic highlighted by Commissioner Rob Califf in his email informing others of Shuren’s resignation.
Shuren also pursued regulatory advancements in other areas, including the contentious rule to govern lab-developed tests. These tests had previously operated in a regulatory gray area, and Congress failed to pass legislation that would explicitly grant the FDA authority over these tests. With legislative action stalled, Shuren took proactive steps to regulate these tests, which led to substantial pushback, including legal challenges by lab groups. The future of this rule is currently uncertain, especially in light of recent judicial shifts such as the overturning of the Chevron doctrine by the Supreme Court—a change that potentially makes federal rules more susceptible to legal challenges.
As Shuren prepares to depart from the FDA, his contributions are under review, reflecting a significant period of growth and development in the regulation of medical devices, alongside challenges and controversies related to the expansion of regulatory oversight. His departure marks the end of a considerable era at the FDA, and the impact of his initiatives, such as the breakthrough devices program, and the evolving landscapes of medical device regulation, will likely continue to resonate for years to come.
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