“Our center experts and programs help get safe and effective technologies to patients and health care professionals on a daily basis and continue to assure devices are safe and effective once on the market,” says Dr. Shuren. “Rapid technological advances enable us to approve innovations that make a difference in people’s lives. I could not be more proud of my fellow colleagues at CDRH, the family we have built, and what we have accomplished together on behalf of the American public.” (Source)
Dr. Jeff Shuren (FDA image)
Dr. Jeff Shuren started his career at the FDA in 1998 and has served as the the Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration since September of 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.
Shuren announced to his team on July 23, 2024 that he will leave the US Food and Drug Administration (FDA) later this year. Starting next week, Michelle Tarver, deputy center director for transformation, will take on the role of CDRH acting director and Shuren will become center director emeritus to faciitate a smooth transition.
Dr. Shuren became the Acting Director of CDRH beginning in September 2009 and was appointed the permanent Director in January 2010. During his tenure, Dr. Shuren has envisioned and implemented initiatives to modernize the regulation of medical devices through a holistic, patient-centric, customer service-focused, total product life cycle approach to oversight and the organizational structure of CDRH.
- Conceiving and co-founding the International Medical Device Regulators Forum to foster global harmonization and the Medical Device Innovation Consortium to advance regulatory science in support of developing innovative technologies and improving device safety and cybersecurity; envisioning and supporting the establishment of the National Evaluation System for health
- Technology to generate real-world evidence to support device authorizations and identify and characterize safety signals
- Launching the Case for Quality Initiative to improve device quality and safety and facilitate the adoption of advanced manufacturing technologies
- Establishing the the Breakthrough Devices Program and Safety and Performance Based Pathway to address the unmet medical needs of people and foster the development of safer, more effective technologies
- Establishing the Collaborative Communities Initiative to drive the development of community-generated solutions within the medical device ecosystem
- Establishing the Network of Experts to expedite and expand access to external expertise to inform center decision making, and the Parallel Review Program with CMS to streamline the pathway from FDA authorization to CMS national coverage determination
- Spearheading CDRH’s efforts on patient engagement and the science of patient input, including creation of the Patient Engagement Advisory Committee , advancing the development of digital health technologies and the creation of the Digital Health Center of Excellence, and piloting the Total Product Life Cycle Advisory Program to expedite patient and health care professional access to and spur greater investment in the development of breakthrough devices.
AdvaMed Statement on
on Dr. Jeff Shuren’s Retirement
WASHINGTON – Today, AdvaMed President and CEO Scott Whitaker released the following statement about U.S. Food and Drug Administration Center for Devices and Radiological Health Director, Dr. Jeff Shuren:
“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. 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.”
“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.”