- Advised manufacturers of FDA-regulated products on regulatory, quality and compliance matters, resulting in successful clearances, approvals, and breakthrough device designations.
- Evaluated and developed efficient regulatory strategies and clinical studies to advance innovative medical devices, AI/ML software products, combination products, and pharmaceutical products.
- Drafted and reviewed successful 510(k)s, de novos, PMAs (both original and supplements), pre-submissions, 513(g)s, IDEs, EUAs, and breakthrough device designation requests.
- Reviewed and provided feedback on promotional materials and product labeling.
- Assisted with determining regulatory requirements for product modifications, including design, supplier, and manufacturing changes.
- Performed FDA due diligence on complex life sciences mergers and acquisitions.
- Guided medical device companies through the Early Feasibility Studies (EFS) Program, including the development of pre-clinical and clinical testing protocols to support clearance or approval.
- Worked with a leading trade association and major hearing aid manufacturers to provide comments on the proposed over-the-counter hearing aids rule.
- Served as the FDA’s Technical Expert for the Association for the Advancement of Medical Instrumentation (AAMI) cochlear implants standard and ISO cochlear implants standard.
- FDA point of contact for hearing device manufacturers and academia on inquiries and issues related to the FDA regulatory and administrative process.
Associate,
- Phone: +1 202 239 3485
- Email: philip.won@alston.com
Philip possesses extensive knowledge of medical device regulation, with seven years of experience at the FDA and over a decade of research expertise as a biomedical engineer with an extensive publication record.