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BioWorld - Monday, March 23, 2026
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Home » Stakeholders see more holes in FDA’s revised CDS draft guidance
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Stakeholders see more holes in FDA’s revised CDS draft guidance

Dec. 31, 2019
By Mark McCarty
The FDA's revised draft guidance for clinical decision support (CDS) systems was intended to fix several glaring holes in the first draft, but multiple stakeholders argued that the second draft contradicts the related provisions of the 21st Century Cures Act when it comes to CDS systems that purport to drive or guide clinical decision making.
Medical technology Regulatory Digital health FDA

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