Navigating the FDA’s Total Product Lifecycle Framework for Generative AI Devices
July 10, 2025
,
11:00 am
EST
•
60
mins
Recorded on
July 10, 2025
•
60
mins
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
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