John J. Smith, M.D., J.D.
Partner Global Regulatory
Languages
English
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Overview
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Experience
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Credentials
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Insights and events
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 Hogan Lovells’ 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, 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.
Representative experience
Assisting with submissions for diagnostic and therapeutic medical devices, including pre-subs, IDEs, 510(k)s, de novo requests, and PMAs.
Assisting with “first in class” marketing submissions for AI-based devices in radiology, gastroenterology and pathology.
Preparing clients for successful advisory panel meetings for first-in-class medical devices, as well as reclassification petitions.
Assisting clients in successful utilization of the submission-issue meeting request process.
Representing multiple clients in successful supervisory appeals at the Center for Devices and Radiological Health.
Assisting clients in obtaining a direct de novo reclassification for a first-in-class medical device without the need for clinical data.
Assisting a client in the preparation of successful humanitarian use device and humanitarian device exemption applications.
Advising multiple clients regarding advertising and promotional issues related to cleared and approved medical devices.
Related case studies
Supporting P-Cure in bringing innovative medical technology to the US
Credentials
- J.D., University of Virginia School of Law, Order of the Coif, 1993
- M.D., University of Virginia, 1992
- B.A., Brown University, magna cum laude, 1986
- District of Columbia
- Virginia (inactive)
- Chair, Committee on Resolutions and Bylaws, Radiological Society of North America
- Member, American College of Radiology
- Member, Virginia State Bar