What FDA Clinical Decision Software requires
The FDA Guidance on Clinical Decision Support (CDS) Software (2022) provides the criteria under which software functions are NOT considered medical devices under Section 520(o)(1)(E) of the FD&C Act. It focus on ensuring that the healthcare professional (HCP) can independently review the basis for the software's recommendations to ensure patient safety.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.1.1 · Last updated:
Primary source: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
SHA-256 integrity: 7e3ae9791c3842f7010a82b831917572833d6a6452c2d1790dc6707d90ff3046
Primary Citations — 6 traced to source
- Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(o)(1)(E))
- FDA Guidance Document: Clinical Decision Support Software (September 28, 2022)
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