AI for eSTAR: Faster FDA 510(k) Submissions

The FDA’s eSTAR 510(k) process is detailed, structured, and time-consuming especially when teams are juggling device documentation, testing evidence, labeling, and cross-functional inputs. In this Friday In-Focus session, Seth Mack, James Standler, and Anish Mariathasan (Co-Founders of Regulos) walk through how AI can help MedTech teams move faster through eSTAR—by organizing content, accelerating drafting, improving reuse, and reducing last-minute scramble—while keeping human oversight and submission quality front and center. What you’ll learn: • Why eSTAR slows teams down (and where the real bottlenecks are) • How AI can support drafting, reuse, and traceability across eSTAR sections • Practical workflows for faster compilation without sacrificing accuracy • Common pitfalls in eSTAR submissions and how to avoid them • How to think about “human-in-the-loop” controls for regulatory-grade outputs • Q&A on real-world use cases, constraints, and adoption Speakers: • Seth Mack — Co-Founder, Regulos • James Standler — Co-Founder, Regulos • Anish Mariathasan — Co-Founder, Regulos Hosted by Sean Smith / MLVx Chapters below 00:00 – Welcome & session overview: why eSTAR is hard (and where time is lost) 03:10 – Meet Regulos: what the team is building and who it’s for 06:45 – eSTAR breakdown: key sections and typical bottlenecks 12:30 – Where AI helps most: reuse, drafting, consistency, and completeness checks 18:40 – Workflow demo: turning existing docs into eSTAR-ready content 26:10 – Human oversight: controls, review steps, and defensibility 33:25 – Quality pitfalls: hallucinations, missing evidence, and traceability gaps 40:15 – Practical adoption: how teams start small and scale safely 48:20 – Q&A: real scenarios from regulatory teams 56:40 – Wrap-up: key takeaways + next steps