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Legal Insights and Perspectives for the Healthcare Industry

FDA Revamps Draft Guidance for Clinical Decision Support Software

By Michele L. Buenafe
// October 17, 2019

The US Food and Drug Administration (FDA) recently issued new draft guidance on clinical decision support (CDS) software that revamps the agency’s interpretation of the 21st Century Cures Act and proposes new policies of enforcement discretion for some categories of CDS software. In a recent LawFlash, Morgan Lewis partner Michele Buenafe details key takeaways from the revised guidance, which is a significant departure from the 2017 draft.

Read the LawFlash >

Tags: 21st Century Cures Act, Clinical Decision Support, Digital Health, FDA
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Michele L. Buenafe

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