Remove Hospital Remove Lab Testing Remove Manufacturing Remove Provider
article thumbnail

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

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.

Clinic 52