Sponsored By

Shuren Leaves FDA’s CDRH After 15-year Tenure

The director of the FDA's Center for Devices and Radiological Health (CDRH) made the announcement at an agency meeting yesterday.

Norbert Sparrow

July 24, 2024

2 Min Read
FDA logo
Image courtesy of FDA

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) for almost 15 years, has announced that he will leave FDA later this year, several media outlets are reporting. Michelle Tarver, deputy center director for transformation, will take on the role of CDRH acting director starting next week, reported Regulatory Focus yesterday.

CDRH oversees the premarket approval of all medical devices, as well as the manufacturing, performance, and safety of those devices.

shuren_headshot.jpeg

Shuren made the announcement at a CDRH meeting on July 23. He said that he will take on the role of center director emeritus on July 28, when Tarver will take the reins until a new permanent director is named.

Shuren began his career at FDA in the commissioner’s office in 1998. As director of CDRH, he created the “breakthrough devices” program, which has proved to be immensely popular with device makers seeking expedited approval and reimbursement, reports STAT.

“As CDRH Director since 2009, Jeff has been a catalyst for the modernization of medical device regulation and innovation in every sense of the word,” wrote FDA Commissioner Robert Califf in an agency-wide email, according to Regulatory Focus. “He has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as director. Jeff’s accomplishments are varied and far too many to recount here.”

Medtech industry association AdvaMed issued a statement thanking Shuren for his career of service. “Jeff understood the critical role a regulator plays in the innovation ecosystem, knowing how to balance the ultimate goal of medical device safety and effectiveness with the important goal of spurring innovations that improve and save lives,” wrote AdvaMed President and CEO Scott Whitaker. “He saw AdvaMed and the medtech industry we represent as partners in addressing patients’ needs, and we hope his leadership serves as a model for all future directors of the CDRH. His willingness to work with us to support next-generation innovation, and his strategic vision for the center have been critical to allowing medtech innovators to do what they do best. We wish him all the best in the next phase of his life and career.”

About the Author

Norbert Sparrow

Editor in chief of PlasticsToday since 2015, Norbert Sparrow has more than 30 years of editorial experience in business-to-business media. He studied journalism at the Centre Universitaire d'Etudes du Journalisme in Strasbourg, France, where he earned a master's degree.

www.linkedin.com/in/norbertsparrow

Sign up for PlasticsToday newsletter

You May Also Like