FDA Medical Devices Chief Jeff Shuren Announces Retirement

After nearly 15 years of leading the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), Jeff Shuren, MD, JD, announced yesterday his plans to retire.

In an internal document provided to TCTMD by CDRH, FDA Commissioner Robert Califf, MD, reflects on Shuren’s tenure at the agency as well as the transition of Deputy Director Michelle Tarver, MD, PhD, to serve as acting director of CDRH, effective July 28, 2024.

Califf notes that Shuren, a neurologist who has held a variety of policy and planning positions within the FDA since the late 1990s, “has been a catalyst for the modernization of medical device regulation and innovator in every sense of the word [and] has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as Director.”

During Shuren’s tenure, a host of groundbreaking cardiovascular devices gained regulatory approval or saw their scope expand, including transcatheter heart valves, stent retrievers for stroke, leadless pacemakers, implantable pulmonary artery pressure monitors for heart failure, devices for patent foramen ovale closure, left atrial appendage occluders, the first artificial intelligence-based technologies, and many more.

Shuren also steered the FDA through a range of cardiovascular device controversies: the mortality signals seen with paclitaxel-coated devices in PAD, the bumpy recall of HeartWare ventricular assist devices, mounting concerns over inferior vena cava filters, and the market removal of bioresorbable scaffolds scarcely a year after they’d been FDA approved, among others.

Shuren became acting director of CDRH in September 2009 and was appointed permanent director in January 2010. As CDRH director, he created and/or oversaw creation of:

• The International Medical Device Regulators Forum and the Medical Device Innovation Consortium
• The National Evaluation System for Health Technology 
• The Case for Quality Initiative
• The Breakthrough Devices Program and Safety and Performance Based Pathway
• The Collaborative Communities Initiative
• The Network of Experts
• The Parallel Review Program with CMS
• The Patient Engagement Advisory Committee

Tarver, an ophthalmologist and epidemiologist, has been with the FDA since 2009. Among her accomplishments are taking the lead on CDRH’s patient engagement efforts and being actively involved in fostering research in patient-reported outcomes and patient preference information to inform medical device evaluation. She also has been instrumental in several of the center’s transformative projects and initiatives, including the recently launched Home as a Health Care Hub, which reimagines a patient’s home environment as an integral part of the healthcare system and a catalyst for advancing health equity.

In Shuren’s internal announcement to staff, also provided to TCTMD, he notes that since he began as director, “the number of innovative medical devices we authorized annually in the US increased fivefold; the number of authorizations in 2023 being the highest in the almost 50-year history of the medical device program. And today, more than 50 percent, and as many as 70 percent, of manufacturers of newly authorized novel technologies for the US market bring their devices to the US first or in parallel with other major markets.”

According to Shuren, Tarver has his full support, having “seen her grow into the incredible leader she has become.”