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    Clinical Decision Support

    Software providing healthcare professionals with knowledge and patient-specific information.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Clinical Decision Support (CDS) software analyzes data within EHRs or directly from devices to help providers make clinical decisions. Some CDS functions are excluded from FDA device regulation under Section 3060 of the Cures Act when criteria are met.

    What this means in practice

    Whether a CDS function is a regulated device depends on transparency of the basis for recommendations and time-criticality of the underlying condition.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1IMDRF·1MDCG·1
    1. 1
      FDA CDS Guidance
      Verified
      FDAfda.gov
    2. 2
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org
    3. 3
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.