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: 23868cd9d47b5137c1c8199bcb516dc0f6cb02254beb13ecd28ba1e60c642693
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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