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AI Assurance Lab Concept Leaves Potential Regulatory Gap

 
• By Derrick Gingery

In an interview with Medtech Insight sister publication the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

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The FDA is investing in AI lifecycle management, Tazbaz said. • Source: Shutterstock

Assurance labs, a potentially key part of the development of artificial intelligence for medtech industy use, are not part of the official regulatory process yet, which could raise questions for the US Food and Drug Administration as the technology pushes further into the industry.

Key Takeaways

  • The FDA’s AI regulatory process currently cannot oversee assurance labs that would help test the algorithms to ensure they are working as intended.

  • Troy...

AI models in development for medical product research and clinical practice are expected to need oversight before and after deployment to ensure they run as intended.

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