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 Blog
OCTOBER 10, 2022
The CDS Guidance lists four general types of medical information that would meet the definition of “medical information about a patient”—a radiology study report, an ECG report, a blood pressure result, and a lab test result—but these examples shed little insight on how to apply the interpretation in practice. software or labeling.
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