The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act
FDA Law
OCTOBER 10, 2022
You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).
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