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
A brilliant algorithm or innovative device is only the beginning.
Presented by the UCLA Clinical and Translational Science Institute (CTSI), in partnership with Caltech, this lively, case-study-driven webinar connects regulatory expertise with translational innovation to help researchers move promising technologies toward real-world clinical impact.
Through real-world examples, the session will explore how intended use, risk, validation, usability, and clinical oversight shape a successful regulatory strategy.
Marlene Berro, MS, RAC, Director of FDA Affairs with the UCLA CTSI Office of Clinical Research, translates complex FDA requirements into practical, accessible guidance for researchers, clinicians, engineers, and medical-device innovators across the UCLA and Caltech communities. Attendees 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.
Who should attend?
Researchers, clinicians, engineers, medical-device innovators, faculty, trainees, and research staff interested in developing and advancing software, AI-enabled technologies, and medical devices.
