Regulating AI in Medical Devices: Lessons from the FDA and the Shifting U.S. and EU Regulatory Landscapes

As AI continues to drive innovation in medical devices, understanding and navigating the evolving regulatory frameworks in both the United States and Europe has become essential
Exploring how the FDA has approached AI-based device submissions over the past 12 years, including recent experiences with the FDA’s ELSA platform, and contrasts this with the emerging regulatory structure of the EU AI Act
Drawing on real-world experience and lessons learned from over a decade of successful FDA submissions, pre-subs, and regulatory engagements
Delving into practical insights into what works, what’s changed, and how to prepare for the future of AI regulation in medical devices