Understanding the FDA's New Draft Guidance on AI-Enabled Devices

In this webinar, you will learn about the FDA’s January 2025 draft guidance and its impact on AI-enabled devices, how to align with IEC 62304, and implement a Total Product Lifecycle (TPLC) approach.

This webinar explores:

✅ Key sections of the draft guidance, including data management, model validation, and labeling

✅ Strategies for aligning IEC 62304-compliant quality management systems to the guidance

✅ How the guidance complements the FDA’s Predetermined Change Control Plan for iterative AI model improvement

Hear from Jenn Dixon, P.Eng, Client Operations Manager at Ketryx, and Eric Henry, Sr. Quality Systems & Compliance Advisor at King & Spalding, as they share their expertise and practical insights.