Regulatory Webinar
Presented by the UCLA Clinical and Translational Science Institute (CTSI) in partnership with Caltech
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Great Idea, What's Next? FDA Strategy for Software, AI and Medical Devices
Wednesday, October 14, 2026 | 12:00pm - 1:00pm PT
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 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.
Who is encouraged to attend:
- Researchers developing software, AI-enabled technologies, or medical devices
- Clinicians involved in device innovation or clinical evaluation
- Engineers and product developers
- Faculty, trainees, and research staff
- Entrepreneurs and innovators seeking to understand FDA requirements
- Anyone interested in translating healthcare technologies from concept to clinical practice
Meet the Speaker
Marlene Berro, MS, RAC
Marlene Berro serves as Director of FDA Affairs for the UCLA Clinical and Translational Science Institute (CTSI) Office of Clinical Research. She works with researchers, clinicians, engineers, and innovators to navigate FDA regulatory requirements and advance promising technologies toward clinical use.
In this webinar, Marlene will provide practical guidance on FDA strategy for software, AI, and medical devices, including regulatory pathways, FDA engagement, authorization requirements, and evidence needed to support clinical claims.
Event Co-Sponsors
- Beckman Institute
- Jacobs Institute for Molecular Engineering for Medicine
- The Linde Center for Science, Society, and Policy
- Tianqiao and Chrissy Chen Institute for Neuroscience
- Richard N. Merkin Institute for Translational Research