FDA’s Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

Lexology December 30, 2024
Jones Day

In Short

The Situation: While generative artificial intelligence (“GenAI”) has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug Administration’s (“FDA” or “Agency”) historic approach to regulating medical devices.

The Result: FDA held its first meeting of the Digital Health Advisory Committee (“DHAC”), which offered guidance and recommendations for how FDA should review and regulate GenAI-enabled devices.

Looking Ahead: Given the unique characteristics of GenAI, the DHAC meeting highlights the potential need for additional regulatory controls and approaches to ensure GenAI-enabled devices are safe and effective throughout the total product lifecycle.

On November 20–21, 2024, FDA held the first meeting of the DHAC to obtain feedback and recommendations on...

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