Jongho "Philip" Won Associate 202-737-4286

Overview

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.

Education & Admissions

Education

J.D. with William P. Cunningham Award and Health Law Certificate, University of Maryland Francis King Carey School of Law, 2020.

Ph.D. in Bioengineering, University of Washington, Seattle, WA, 2010.

M.S. in Biomedical Engineering, Hanyang University, Seoul, Korea, 2005.

B.S. in Mechanical Engineering, Hanyang University, Seoul, Korea, 2003

Admissions

Maryland

Experience

  • Reviewed medical device and combination product submissions, including 510(k)s, PMAs (both original and supplements), Breakthrough Device Designation requests, De Novos, IDEs, Pre-Submissions, 513(g)s, and recall and complaint submissions.
  • Reviewed Emergency Use Authorization (EUA) submissions.
  • Evaluated Breakthrough Device Designation requests.
  • Guided medical device manufacturers through the Early Feasibility Studies (EFS) Program, including the development of pre-clinical and clinical testing protocols to support clearance or approval.
  • Served as the FDA’s Technical Expert for the AAMI cochlear implants standard & ISO cochlear implants standard.
  • Served as the FDA point of contact for hearing device manufacturers and academia on inquiries and issues related to the FDA regulatory and administrative process.
  • Served as the EMC (electromagnetic compatibility) focal point in the OHT1, OPEQ, CDRH, FDA.
  • Supported legislative efforts to respond to Congressional inquiries regarding the vaping-related lung illness crisis.
  • Served as the Regional Coordinator for Prevention through Active Community Engagement (PACE) by the United States Public Health Service (USPHS) in Washington DC, Maryland, Virginia, West Virginia, and Pennsylvania.

Honors & Awards

  • US Public Health Service, Presidential Unit Citation for the COVID-19 response, 2021
  • FDA, Nominated for the CDRH Honor Award for the Tusker original PMA review, 2021
  • William P. Cunningham Award, University of Maryland Francis King Carey School of Law, 2020
  • US Public Health Service, COVID-19 Pandemic Campaign Medal, 2020
  • US Public Health Service, Unit Commendation, 2020
  • US Public Health Services, Nominated for PHS Citation for the vaping related lung disease public health crisis response, 2020
  • CALI Excellence for the Future Awards for Health Law Seminar: Fraud & Abuse, 2020.
  • FDA, Achievement Medal, The da Vinci SP system review team, 2019
  • FDA CDRH, ROCC Award, 2019, 2020
  • FDA, Gold Star Award, 2018

Speaking Engagements

  • Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee. Premarket to postmarket shift in clinical data requirements for cochlear implant device approvals in pediatric patients, May 1, 2015
  • Introduction to Cochlear Implants, FDA CDER’s Learn About Science, Oct 30, 2018
  • Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs for Medical Device Development hosted by the NIH/NIDCD at the Annual Conference of Association for Research in Otolaryngology (ARO), 2017, 2019
Education

J.D. with William P. Cunningham Award and Health Law Certificate, University of Maryland Francis King Carey School of Law, 2020.

Ph.D. in Bioengineering, University of Washington, Seattle, WA, 2010.

M.S. in Biomedical Engineering, Hanyang University, Seoul, Korea, 2005.

B.S. in Mechanical Engineering, Hanyang University, Seoul, Korea, 2003

Admissions

Maryland

Practice Areas
Industries
FDA Regulatory Categories