John J Smith

As both a physician and a lawyer, John Smith combines clinical and regulatory experience relating to the Food and Drug Administration (FDA) with a practical approach to addressing the FDA regulatory issues facing his clients. He focuses on bringing device-based technologies to market and has worked extensively in the AI-based image analysis space, assisting clients with computer-assisted triage, detection and diagnostic products in radiology, cardiology, gastroenterology, pathology, and ophthalmology, as well as other disciplines. He is familiar with FDA’s complex data requirements in the AI-space and well-known to the Agency for his work in the field.

A board-certified diagnostic radiologist and former associate professor of radiology at Harvard Medical School, John joined the Hogan Lovells Cadwalader Medical Device Group in 2005. Since then, he has assisted clients in a range of FDA premarket submissions, including 510(k) notices, de novo requests, humanitarian device exemption applications, and premarket approval applications, including the advisory panel process.

John identifies successful regulatory strategies and presents them to the FDA via the pre-submission process; he assists with problem submissions through submission-issue meetings and administrative appeals. He also navigates the increasingly challenging FDA compliance landscape, addressing 483 and Warning Letter issues.

Having worked in the medical device area in academia, industry, and at Hogan Lovells Cadwalader, John understands how to address both pre- and postmarket FDA regulatory issues. His practical approach has guided clients through successful marketing applications, addressed significant differences of opinion with the FDA through submission-issue meetings and regulatory appeals, and provided crucial support through challenging FDA enforcement actions. A Super Lawyers designee for multiple years, John is a leader in the medical device bar and well known to the FDA.