PRINCIPAL REGULATORY SPECIALIST
Joined: June 9, 2026
As a former FDA acting branch chief and lead medical device reviewer with nine years at CDRH, I advise 17 AI/ML SaMD projects across De Novo, 510(k), and IDE pathways. At Innolitics I guide founders and funded AI/ML device companies through classification, Pre-Sub responses, and submission strategy. Before Innolitics I was Senior Director of Regulatory Affairs and Quality Assurance at ConvaTec and Senior Vice President of Regulatory Affairs at AscentX Medical, worked at St. Jude Medical, and founded FDA Blueprint and Mr. Regulatory, helping [X] startups win IDE approvals and 510(k) clearances. I teach Regulatory Submissions for Medical Devices at UC San Diego Extended Studies, presented at RAPS Convergence 2024, and am a founding member of the Kidney Health Initiative. I hold a Master of Mechanical Engineering from Johns Hopkins University and a BSE in Biomedical Engineering from Case Western Reserve University.
David Pudwill is a seasoned leader and regulatory expert who helps companies get innovative medical devices and combination products to market. David has served in senior leadership roles at AscentX Medical and ConvaTec, and previously worked at the U.S. Food and Drug Administration (FDA), and St. Jude Medical. He is a founding member of the Kidney Health Initiative, and has helped several startups acquire funding and successfully interact with FDA and the Department of Defense. While at FDA, David worked on DARPA projects and consulted with CBER and CDER regarding regulatory submissions, including clinical studies and marketing submissions, and reviewed FDA regulated software submissions as well as FDA regulated products that incorporated software functions.
David holds a Master of Mechanical Engineering from Johns Hopkins University, a BSE in Biomedical Engineering from Case Western Reserve University, and a Certificate from HBX, now Harvard Business School Online.