FDA Names New Leader for Medical Device Division
The Food and Drug Administration has appointed Dr. Jeffrey Shuren as the new director of its Center for Devices and Radiological Health (CDRH), marking a significant leadership change in the agency's medical device regulation division. Dr. Shuren, who has been serving as the center's acting director, brings extensive experience in medical device regulation and public health policy to the permanent role.
Dr. Shuren's appointment comes at a crucial time as the FDA faces increasing challenges in regulating rapidly evolving medical technologies, including artificial intelligence-powered devices and innovative diagnostic tools. His previous experience includes serving as the FDA's Associate Commissioner for Policy and Planning, and he has played a key role in modernizing the agency's approach to device regulation.
Key priorities under Dr. Shuren's leadership will include:
- Streamlining the medical device approval process while maintaining safety standards
- Enhancing post-market surveillance of medical devices
- Advancing the FDA's Digital Health Center of Excellence
- Strengthening cybersecurity requirements for connected medical devices
The appointment has been welcomed by industry stakeholders, who view Dr. Shuren's experience and understanding of both regulatory requirements and technological innovation as valuable assets in leading the CDRH. His leadership will be particularly important as the medical device industry continues to evolve with new technologies and approaches to patient care.
Dr. Shuren will oversee a division responsible for regulating thousands of medical devices, from simple bandages to complex imaging systems and implantable devices, ensuring they meet safety and effectiveness standards while facilitating innovation in the medical technology sector.
