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

July 10, 2025

11:00 am EST  
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

### Clips from this Webinar

## Speakers

### Jenn Dixon
Director of AI Quality & Regulatory Strategy

### Erez Kaminski
Founder & CEO
Head of AI, Amgen

[Register now](/content/learn/webinars/register/navigating-the-fdas-total-product-lifecycle-framework-for-generative-ai-devices-2#register/index.html)