UCLA CTSI: Great Idea, What's Next?

Great Idea, What's Next? FDA Strategy for Software, AI and Medical Devices

Presented by the UCLA Clinical and Translational Science Institute (CTSI), in partnership with Caltech, this webinar connects regulatory expertise with translational innovation to help researchers move promising technologies toward real-world clinical impact.

Marlene Berro, MS, RAC, Director of FDA Affairs with the UCLA CTSI Office of Clinical Research, will provide practical, accessible guidance on navigating FDA requirements for software, AI, and medical devices.

Researchers, clinicians, engineers, and medical device innovators will learn when software is, or is not, considered a medical device; what may be marketed without FDA authorization; when a 510(k) or other premarket submission may be required; when to engage the FDA; and what evidence is needed to support clinical claims.

Through real-world examples, the session will explore how intended use, risk, validation, usability, and clinical oversight shape a successful regulatory strategy.