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 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. Interpretation of Statutory Criteria Under the Final Guidance. The final guidance focuses on labeling as a means to effectuate Criterion 4.
52 
Let's personalize your content