FDA’s CDRH Director Jeff Shuren to Retire

The FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeff Shuren, has announced his plan to retire. Starting July 28, Shuren will transfer to the commissioner’s office and will remain as a center director emeritus for the time being. 

 

Until a replacement is found, Deputy Center Director for Transformation, Dr. Michelle Tarver will assume the role of CDRH acting director, effective July 28. 

 

Shuren has worked at the FDA for 28 years. During his tenure, Shuren implemented initiatives to modernize the regulation of medical devices through a holistic, patient-centric, customer service-focused, total product life cycle approach.

 

From 1998 to 2009 he served in a variety of policy and planning positions within the Office of the Commissioner. He also served as a detailee on Senator Edward Kennedy’s staff on the Senate Health, Education, Labor, and Pensions Committee in 2000. 

 

From 2001 to 2003 Shuren served as Director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services (CMS). During that time he oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.

 

Shuren became the Acting Director of CDRH beginning in September 2009 and was appointed the permanent Director in January 2010. Shuren was instrumental in growing and developing numerous programs to help improve the safety, development, and regulation of medical devices and technologies. 

 

Notable accomplishments include conceiving and co-founding the International Medical Device Regulators Forum and the Medical Device Innovation Consortium. He also supported the National Evaluation System for Health Technology, and launched the Case for Quality Initiative, Breakthrough Devices Program and Safety and Performance Based Pathway, among other programs.

 

“On behalf of the entire medtech industry, I want to thank Dr. Shuren for his incredible career of service to patients and public health. 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,” said AdvaMed President and CEO Scott Whitaker.