The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, "Towards Better Speech Perception and Beyond."
A standout highlight of the symposium is the anticipated presentation by Dr. Philip Won, of Hyman, Phelps & McNamara, P.C. Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Notably, Dr. Won's career path included a tenure at FDA's Center for Devices and Radiological Health (CDRH), Division of Dental and ENT Devices within the Office of Product Evaluation and Quality. During this time, he deftly led multi-disciplinary teams, comprised of engineers, scientists, and clinicians, in the review of intricate submissions that left an indelible mark on the industry.
Beyond his regulatory acumen, Dr. Won is an accomplished author, boasting a portfolio of more than 40 peer-reviewed journal articles, spanning various aspects of hearing devices (see his Google Scholar page). His unique background underscores his remarkable expertise as a cochlear implant researcher, a former FDA regulator, and his current role as a device attorney. During his presentation at the symposium, Dr. Won will share invaluable insights into effective regulatory strategies that empower companies to navigate the intricate FDA approval process for cochlear implants.
The comprehensive agenda for the symposium can be accessed in its entirety here.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
