CTSI and Caltech host webinar on FDA strategy for software, AI, and medical devices

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

CTSI Regulatory Webinar
By UCLA CTSI
1 min read

The UCLA Clinical and Translational Science Institute (CTSI), in partnership with Caltech, hosted the webinar Great Idea, What's Next? FDA Strategy for Software, AI and Medical Devices on October 14, bringing together researchers, clinicians, engineers, entrepreneurs, and innovators to explore regulatory considerations for software, artificial intelligence (AI), and medical technologies.

The webinar featured Marlene Berro, MS, RAC, Director of FDA Affairs for the UCLA CTSI Office of Clinical Research, who provided practical guidance on navigating FDA requirements for software, AI, and medical devices. Through real-world examples, attendees learned how regulatory strategy can support the successful development and translation of healthcare technologies from concept to clinical impact.

Following the presentation, Arash Naeim, MD, PhD, CTSI Regulatory Knowledge and Support Program Co-Lead, moderated a panel discussion featuring regulatory and compliance leaders from UCLA, Caltech, and Cedars-Sinai. Panelists included:

  • 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, Department of Medicine overseeing Research Compliance, UCLA

The event attracted 273 registrants and 135 live attendees representing academic institutions, healthcare organizations, government agencies, and industry partners. Attendees included representatives from UCLA, Cedars-Sinai, the Lundquist Institute, Caltech, Children's Hospital Los Angeles, Children's Mercy Kansas City, the University of Kansas Medical Center, the University of Pennsylvania, the University of Utah, the University of Illinois Chicago, and numerous additional organizations nationwide.

For more information or to schedule a regulatory consultation, visit the CTSI Office of Clinical Research's FDA Affairs program webpage.