Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices

July 10, 2025, 11:00 am EST

Generative AI devices hold transformative potential for healthcare, but ensuring their safety and effectiveness demands robust lifecycle management strategies. Building on the FDA’s Total Product Lifecycle Considerations for Generative AI-Enabled Devices, this session provides actionable insights to help you align with regulatory expectations while driving innovation.

What you'll learn

• Evidence needs for Generative AI devices, including transparency in training datasets, performance metrics, and validation of off-the-shelf Generative AI used in products
• Postmarket monitoring strategies, such as managing evolving foundation models
• Best practices for dataset management, with a focus on traceability and maintaining quality across the product lifecycle

Who should attend

Speakers

Jenn Dixon

Director of AI Quality & Regulatory Strategy

Erez Kaminski

Founder & CEO

Formerly Head of AI, Amgen