“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.