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Regulating AI Like a Doctor: FDA Floats Competency-Based Path for Generative AI-Enabled Devices // Cooley // Global Law Firm
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Regulating AI Like a Doctor: FDA Floats Competency-Based Path for Generative AI-Enabled Devices // Cooley // Global Law Firm
On August 18, 2026, the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) released a discussion paper proposing new approaches to regulating medical devices enabled by generative artificial intelligence (genAI), and requesting stakeholder feedback, which must be submitted by October 19, 2026. The paper is not guidance, but it offers insight into how the agency is thinking about the unique risks and evidentia…
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