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- FDA releases discussion paper seeking input on regulation of generative AI medical devicesThe U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
- FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reformThe U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…