Understanding the FDA's New Draft Guidance on AI-Enabled Devices: What MedTech Companies Need to Know

February 26, 2025, 11:00 am EST • 60 mins

The FDA’s January 2025 draft guidance on AI-enabled devices is a significant step forward, offering a framework for manufacturers to bring innovative, AI-driven devices to market while maintaining safety and regulatory compliance. However, applying this guidance to the software development lifecycle and aligning it with IEC 62304 presents unique challenges. This webinar will help you bridge the gap, equipping you to better implement a Total Product Lifecycle approach.

What you'll learn

• Key sections of the draft guidance, including data management, model validation, and labeling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

Who should attend

Clips from this Webinar

Speakers

Jenn Dixon

Director of AI Quality & Regulatory Strategy

Eric Henry

Senior Quality & Regulatory Compliance Advisor

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