Honoring Dr. Jeffrey Shuren’s 15 Years of Transformational Leadership at FDA’s CDRH

The Medical Device Innovation Consortium (MDIC) extends heartfelt gratitude and admiration to Dr. Jeffrey Shuren for 15 years of exemplary service as the Director of the FDA Center for Devices and Radiological Health (CDRH). Dr. Shuren’s vision and commitment have profoundly shaped the landscape of medical device innovation, regulatory science, and patient care.

One of Dr. Shuren’s enduring legacies is his co-founding of MDIC, which stands as a testament to his belief in collaboration. Under his guidance, MDIC has united regulators, medical device innovators, and healthcare stakeholders to advance clinical and regulatory science.

MDIC’s pioneering programs have led to significant advancements in manufacturing quality and regulatory pathways. These efforts have informed regulatory decision-making, ensuring innovative devices reach patients who need them most. MDIC’s collaborative work has improved patient outcomes and access to cutting-edge medical technologies.

Initiatives such as the Case for Quality, the National Evaluation System for Health Technology (NEST), and the Early Feasibility Studies program exemplify how industry, regulators, and stakeholders can work together to achieve groundbreaking improvements. These programs have enhanced clinical trial efficiency, bolstered post-market surveillance, and promoted a culture of quality in manufacturing, benefiting both regulators and developers while enhancing patient care.

Dr. Shuren’s involvement in the Voluntary Improvement Program (VIP) has helped medical device organizations produce high-quality devices, ultimately increasing patient safety. The transition of VIP from a pilot to a full program is a testament to his dedication to continuous improvement.

His advocacy for the Science of Patient Input program has advanced the inclusion of patient perspectives in the development, pre-market approval, and post-market evaluation of medical devices. This initiative has ensured that medical technologies are innovative and aligned with patient needs and expectations.

Dr. Shuren’s tenure at CDRH, including his support for creating collaborative communities, will have lasting benefits for patients and healthcare. His efforts have ensured that innovative devices reach patients efficiently, improve the quality of care, and deliver life-changing outcomes. His leadership has fostered an environment of collaboration and innovation, setting a high standard for regulatory excellence and patient-centered care. MDIC thanks Dr. Shuren for his extraordinary service and steadfast championing of MDIC’s mission.