Devices

Shuren Retiring; Tarver is Acting CDRH Director

After a 28-year career in federal service, CDRH director Jeff Shuren says he is retiring later this year. Deputy Center director for transformation Michelle Tarver will serve as acting Center director beginning 7/28.

To ensure a smooth transition, Shuren is moving to the Commissioner’s Office while FDA begins a nationwide search, according to a notice from commissioner Robert Califf. “Jeff will assist in the transition as Center director emeritus, and officially leave the FDA later this year,” he says.

Shuren has served as CDRH director since 2009. Califf acknowledges that he has been a “catalyst for the modernization of medical device regulation and innovator in every sense of the word. He has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as director.” His accomplishments include co-founding the International Medical Device Regulators Forum and the Medical Device Innovation Consortium; establishing the Breakthrough Devices Program and Safety and Performance Based Pathway; creating the Health Center of Excellence; and piloting the Total Product Life Cycle Advisory Program.

Additionally, Califf says Shuren steered the Center as the “number of innovative medical devices authorized annually in the U.S. increased five-fold; the number of authorizations in 2023 being the highest in the almost 50-year history of the medical device program – helping ensure our leadership in the medical device ecosystem both at home and abroad.”

Tarver joined FDA in 2009 as a staff fellow in CDRH’s Office of Surveillance and Biometrics after serving as an assistant professor at the Johns Hopkins University School of Medicine. Later she became a medical officer in the Office of Device Evaluation before assuming the role of the director of Patient Science and Engagement at CDRH that oversaw patient science development and policy work as well as patient engagement efforts, including the Patient Engagement Advisory Committee. More recently, she served as Office of Strategic Partnerships and Technology Innovation deputy director where she directed efforts in emergency preparedness and response activities, digital health, conformity standards development and implementation, partnerships, and patient science and engagement.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome