PRINCIPAL REGULATORY SPECIALIST
Joined: August 24, 2026
I spent 22 years at FDA's CDRH working 510(k), PMA, De Novo, and IDE pathways, directed more than 150 Advisory Committee meetings, and oversaw all six CDRH advisory committees. I oversaw all six CDRH advisory committees, trained the center's Designated Federal Officers, prepared both FDA review teams and sponsors for panel, and served as Designated Federal Officer for FDA's first Digital Health Advisory Committee meeting on generative AI in 2024. At Innolitics I bring that reviewer-side view to regulatory strategy, Q-Subs, 510(k) and De Novo submissions, and hold responses for software and AI/ML devices.
I spent 22 years at FDA’s Center for Devices and Radiological Health (CDRH), where I directed more than 150 Advisory Committee meetings and worked extensively with 510(k), PMA, De Novo, and related regulatory pathways. I’m looking forward to bringing that experience to help our clients design, document, and clear safe, effective software and AI medical devices.
Traveling with my wife and 2 kiddos, any type of outdoor sports or hiking and exploring new restaurants with my wife!
ArticleAI/ML
Key takeaways from the September 25 CDRH–MDIC meeting: regulatory predictability can help restore medtech investment; FDA trust in AI depends on validated methods, credible evid...
James Swink
