FDA issues discussion paper on regulation of generative AI-enabled medical devices
emmanuelvivier · x · 2026-08-25
The FDA's Digital Health Center of Excellence released a discussion paper titled "Considerations for the Regulation of Generative AI-Enabled Medical Devices." The paper aims to engage stakeholders on the unique risks and regulatory challenges posed by GenAI medical devices. It covers key topics including risk assessment, premarket evaluation, and postmarket surveillance, requesting feedback to advance regulatory approaches for these transformative technologies.
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