Jongho "Philip" Won, Ph.D.

Dr. Won has extensive knowledge of medical device regulation with 7 years of FDA experience, and 10+ years of medical device research experience as a biomedical engineer. During his tenure at FDA CDRH’s Division of Dental and ENT Devices in the Office of Product Evaluation and Quality, he regularly led a multi-disciplinary team of engineers, scientists, and clinicians to review complex submissions with a high industry impact. His regulatory expert portfolio includes a 510(k), PMA, Breakthrough Device Designation, De Novo, EUA, IDE, Pre-submission, 513(g), and recall and complaint submissions. Prior to joining FDA, Dr. Won served as an Assistant Professor at the University of Tennessee, where he enjoyed designing, funding, and executing research projects focusing on medical device development. As an expert in medical device technology and in the FDA-regulated product life cycle, he has an in-depth understanding of the challenges faced by all stakeholders in the highly regulated and competitive medical device industry.

Dr. Won graduated with William P. Cunningham Award and Health Law Certificate from the University of Maryland Francis King Carey School of Law. While in law school, he interned with the FDA’s Office of Legislation for the Device-Biologics-Tobacco team, where he responded to inquiries from Congressional committees and individual members regarding FDA regulatory policies and programs.