Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Key Takeaways from the AI Trends in Medical Devices Panel at the 2025 FDLI Annual Conference

Ariel Seeley served on the panel titled AI Trends in Medical Devices: Global Developments, FDA Policies, and Software as a Medical Device at the 2025 Food and Drug Law Institute (FDLI) Annual Conference. The panel provided an overview of FDA’s approach to predetermined change control plans (PCCPs) and its draft guidance on pre-market submission requirements for AI-enabled devices, a summary of current trends in devices enabled with artificial intelligence (AI) or…

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https://www.morganlewis.com/blogs/asprescribed/2025/06/key-takeaways-from-the-ai-trends-in-medical-devices-panel-at-the-2025-fdli-annual-conference