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BioWorld - Monday, June 1, 2026
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Home » FDA offers greater clarity in revised draft for CDS software
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FDA offers greater clarity in revised draft for CDS software

Nov. 5, 2019
By Mark McCarty
The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
Medical technology Regulatory Software FDA

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