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Clinic Management

White Paper

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

The FDA Law Blog

OCTOBER 10, 2022

The final guidance does not provide further insight as to what other types of information would be considered “similar” in their level of independent verification and validation, but could be read to exclude any reports, such as sponsor white papers, that have not undergone third-party peer review.

FDA

FDA Labelling Documentation Communication

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

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