4 questions about the FDA’s approach to generative AI

Elise Reuter and MedTech Dive • September 9, 2026

The Food and Drug Administration is working on guidance for use of generative artificial intelligence in medical devices, following years of debate about the technology.

The agency is taking a closer look at generative AI as consumer tools proliferate, but no medical devices on the market today use it in a regulated way.

Medtech firms are watching for what direction the FDA plans to take as big questions loom on how to evaluate devices using the technology for safety and efficacy, and how to ensure they continue to work over time.