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
The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.
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