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
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.
Perspectives from the Field
Following the talk, our moderator will lead a conversation with four panelists and invite questions from the audience.
Moderator
Arash Naeim, MD, PhD
CTSI Regulatory Knowledge and Support Program Co-Lead
UCLA
Panelists
Grace Fisher-Adams, PhD, JD
Associate Vice Provost for Research Policy and Compliance
Caltech
Keren Dunn, CIP
Executive Director, Office of Research Compliance and Quality Improvement
Cedars-Sinai
Marlene Berro, MS, RAC
Director of FDA Affairs
UCLA
Michael Roth, MD
Vice Chairman for the Department of Medicine overseeing Research Compliance
UCLA
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