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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 the regulation says
    The FDA, under Section 3060 of the 21st Century Cures Act, clarifies that certain Clinical Decision Support (CDS) functions are excluded from the definition of a medical device if they meet specific criteria, primarily focusing on transparency to the user and the absence of a time-critical situation. This is further detailed in FDA guidance documents such as "Clinical Decision Support Software" issued in September 2022. The EU Medical Device Regulation (EU MDR 2017/745) does not have a direct equivalent exclusion, generally classifying software that provides information for diagnostic or therapeutic purposes as a medical device, with classification depending on the risk to the patient, as outlined in Annex VIII, Rule 11.

    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.

    Examples

    • A CDS function analyzing patient data to suggest potential drug interactions, but allowing the physician to review the evidence and make the final prescribing decision, exemplifies an excluded function under the Cures Act.
    • Software that provides guidance on appropriate diagnostic tests based on a patient's symptoms, where the physician can independently evaluate the rationale, is an example of an excluded CDS.
    • A CDS system providing real-time alerts for critical vital sign changes in an ICU setting, where immediate action is required, likely falls under FDA regulation due to time-criticality.
    Common pitfalls
    • •A common pitfall is assuming all CDS software is exempt from regulation; only specific functions meeting the Cures Act criteria are excluded.
    • •Misinterpreting "transparency" can lead to non-compliance, as the basis for recommendations must be clearly understandable by a healthcare professional.
    • •Failing to consider the time-criticality of the clinical situation for which the CDS is intended can result in incorrect regulatory classification.
    • •Neglecting to update regulatory assessments when CDS functionalities change can lead to non-conforming products.
    • •Assuming EU MDR classification is identical to FDA Cures Act exemptions will lead to non-compliance in the EU market.

    Frequently asked questions

    The main criteria for exclusion under the Cures Act involve the CDS software providing recommendations that are not intended to acquire or process medical images or signals, for the purpose of informing, rather than driving, clinical management, and allowing the healthcare professional to independently review the basis of the recommendations, and not supporting or providing recommendations in a time-critical situation regarding a diagnosis or treatment.

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    Learning paths (2)

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.