Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

3D rendering of red-and-white cubes with a question mark design.
(Nasirkhan/Shutterstock)

Additional guidance from the US Food and Drug Administration is needed to unlock the full potential of artificial intelligence in the development and regulation of drugs and other medical products, stakeholders told the agency in comments to a January draft guidance.

More than 100 stakeholders responded to “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products” before the comment...

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