Story thread · 2 reports / 2 sources

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

fda.gov · 6h · first report

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Across 2 sources · syndicated copies counted once

The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics

The coverage

  1. FDA wants public input before regulating AI-enabled medical tools

    washingtontimes.com · 3h

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