FDA 'Competency' Take On AI Regs Sparks Legal Concerns

Brigid DeCoursey Bondoc spoke to Law360 about the U.S. Food and Drug Administration's (FDA) discussion paper on the regulation of generative AI medical devices and the agency's push to assess medical devices through competency-based methods, which typically involves a multifaceted process of observations and detailed assessments of a doctor in a clinical setting.

Brigid said the "competency" approach could raise questions about overlapping authority. A device, by nature, is not a person. But state laws don't necessarily exclude regulating devices under their restrictions on the practice of medicine, setting up a potential conflict with federal regulation.

"It could be that you have a situation where FDA can regulate the product as a device, and then at the same time, a state could say this is the practice of medicine," she said.

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