Shuren made the announcement on July 23, according to an FDA internal email shared with MassDevice. On July 28, he will transfer to the commissioner’s office and Dr. Michelle Tarver, deputy center director for transformation, will assume the role of CDRH acting director. Shuren will remain as a center director emeritus before leaving later this year.
Starting in the FDA Commissioner’s Office in 1998, Shuren has spent nearly three decades at the FDA. He became acting director of the Center for Devices and Radiological Health in 2009, receiving an appointment as the permanent director early the following year.
“We made significant changes to existing programs and innovated,” Shuren said in an email to CDRH employees. “We created new programs, policies, practices and processes.”
Under his tenure, the FDA has grown and developed new programs, including creating a breakthrough devices program that allows medtech companies to seek expedited device approval if there isn’t a predicate device for a 510(k) clearance. Shuren also noted the agency revamped clinical trials programs, reorganized to fully support a total product life cycle approach through the Office of Product Evaluation and Quality and established the National Evaluation System for Health Technology.
“Jeff has been a catalyst for the modernization of medical device regulation and innovator in every sense of the word,” FDA Commissioner Robert Califf said in an internal email shared with MassDevice. “He has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as director.”
“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,” AdvaMed President and CEO Scott Whitaker said in a LinkedIn post.
Shuren’s legacy
Shuren told staff in the internal email that he wanted to retire in 2020, but the pandemic forced him to redirect his efforts to help drive the agency through the crisis. “We cannot abandon our posts in a time of crisis,” he said.
The CDRH issued over 225 emergency use authorizations to aid patients and caregivers during the COVID-19 pandemic. Excluding in vitro diagnostics, those devices included essential equipment such as ventilators and ventilator accessories, respiratory assist devices, remote patient monitoring devices, personal protective equipment, infusion pumps and more.
Shuren also said in his email that the number of medical devices the agency has authorized annually has increased five-fold since 2009. Authorizations in 2023 were at the highest rate in the medical device program’s history.
More than 50% and as many as 70% of manufacturers of newly authorized novel technologies in the U.S. market bring their devices to the U.S. first or parallel with other major markets, Shuren noted.
“We have arrived at the destination we set out to reach. We accomplished all of this in an environment of shared respect for one another and collective successes. It is time to set our sights on new worlds,” he said.
His retirement comes as the CDRH develops proposals to reauthorize the Medical Device User Fee Amendments (MDUFA). This will require discussions with industry representatives about what recommendations for reauthorization should be submitted to Congress, with legislation to follow. The multi-stage process could last into 2027, leading Shuren to pass the baton to the agency’s next leader.
“With all this in mind, I have decided that it is the right time for me to hand the conn – the captain’s chair – to a new director who can set a new vision, a new course, that will take our center – our starship – to new places,” Shuren said.
A new acting director is appointed
“In thinking about when to start the transition, it made most sense to start this summer before our preparation for MDUFA reauthorization begins in earnest, and with sufficient time to set a new vision,” Shuren said. “Given that Michelle is taking over the reins, it would be better for the Center if she is the one making the decisions she will execute.”
Tarver’s appointment takes effect on July 28.
“We look forward to working with Dr. Michelle Tarver as Interim Director to ensure the transition to new leadership is smooth, and that Dr. Shuren’s vision of a true public-private partnership remains the hallmark of the Center he helped establish as the gold standard for medical device safety worldwide,” AdvaMed’s Whitaker said.
Tarver started at the FDA as a staff fellow in the CDRH’s Office of Surveillance and Biometrics after serving as an assistant professor at The Johns Hopkins University School of Medicine. Soon after, she became a medical officer in the Office for Device Evaluation before becoming the director of Patient Science and Engagement within the CDRH.
As director of Patient Science and Engagement, she established and built the program that oversees patient science development and policy work and patient engagement efforts, including the Patient Engagement Advisory Committee.
“Michelle has led a number of cross-cutting initiatives, fostered strategic collaborations, published many peer-reviewed papers and received numerous awards for her work, including the CDRH Award of Merit and the American Academy of Ophthalmology Secretariat Award,” Commissioner Califf said in an email.
Shuren appointed Tarver to her most recent role as deputy center director of transformation. In that post, she is responsible for facilitating the development, implementation and direction of CDRH’s transformative projects and initiatives, including the recently announced Home as a Health Care Hub.
She holds two doctorate degrees, a Doctor of Medicine and a Doctor of Philosophy in Epidemiology from The Johns Hopkins University, and a Bachelor of Science in Biochemistry.
