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Free Webinars

# Understanding the FDA's New Draft Guidance on AI-Enabled Devices

February 26, 2025

60

minutes

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In this webinar, you will learn about the FDA’s January 2025 draft guidance and its impact on AI-enabled devices, how to align with IEC 62304, and implement a Total Product Lifecycle (TPLC) approach.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✅ Key sections of the draft guidance, including data management, model validation, and labeling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](https://www.linkedin.com/in/jenn-dixon-p-eng-52573b106/), Client Operations Manager at Ketryx, and [Eric Henry](https://www.linkedin.com/in/eric-henry-519bb48/), Sr. Quality Systems & Compliance Advisor at King & Spalding, as they share their expertise and practical insights.

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