4 questions about the FDA’s approach to generative AI

Brigid DeCoursey Bondoc spoke to MedTech Dive about the U.S. Food and Drug Administration's (FDA) discussion paper on the regulation of generative AI medical devices and its proposal of foundation model device master files, where developers of underlying AI models used to create new models could voluntarily submit information to the FDA that the agency would hold confidentially. 

Brigid said the concept is similar to one the FDA uses for drugs, where a manufacturer of a gel capsule might not want to share proprietary information about the ingredients or how it’s made, but the FDA would need to know this when assessing a drug that uses this capsule. "In essence, this would be a way for the regulator to get information about the foundation models that might be going into a device," she said.

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