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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

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. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic

Clinic Medical Provider Patients

Does the Drug Shortage White Paper Fall Short?

FDA Law

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Supply Chain

Supply Chain Manufacturing Government Hospital

Primary Care Digest

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

Does the Drug Shortage White Paper Fall Short?

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