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    Software & AISoftware LifecycleSaMD /sam-dee/

    Software as a Medical Device

    Software intended for medical purposes that performs without being part of a hardware device.

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

    Definition

    Per IMDRF, Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

    What this means in practice

    SaMD spans diagnostic apps, AI triage tools, and clinical decision support systems. IMDRF risk categorization (I to IV) considers the state of the healthcare situation (non-serious, serious, critical) and the significance of the information the SaMD provides (inform, drive, treat or diagnose). Regulators worldwide, including FDA, MHRA, and Health Canada, align to the IMDRF framework.

    Examples

    • A mobile app that analyzes retinal images to screen for diabetic retinopathy without connecting to hardware.
    • A cloud service that triages CT scans and flags suspected large-vessel occlusion strokes for radiologist review.
    • AI software that estimates ejection fraction from standard echocardiograms.

    Use cases

    1 scenario
    1

    Mobile app analyzing skin lesions for melanoma risk

    Founder / RA

    The app meets the FDA SaMD definition. The team applies IMDRF risk categorization, follows IEC 62304 for software lifecycle, and uses GMLP principles for the underlying model. They submit a 510(k) with a cleared dermatology AI as predicate.

    OutcomeThe product launches as a regulated Class II SaMD with a clear update pathway via a Predetermined Change Control Plan.
    Common pitfalls
    • •Confusing SaMD with SiMD. If the software is embedded in or required to operate a hardware device, it is SiMD and regulated with the parent device.
    • •Assuming a wellness app is out of scope. Once the intended use includes diagnosis, treatment, cure, mitigation, or prevention, the software is likely SaMD.
    • •Skipping IEC 62304 lifecycle documentation because the product feels like a normal SaaS release cycle.
    • •Treating model updates as bug fixes. Retrained AI models often require a Predetermined Change Control Plan or a new submission.

    Frequently asked questions

    SaMD (Software as a Medical Device) performs a medical purpose without being part of a hardware device. SiMD (Software in a Medical Device) is embedded in or required to operate a hardware device, such as pump firmware or imaging system control software.

    Cross-references

    Governed by

    Often confused with

    Related terms

    Shared paths + category
    Software & AI
    Predetermined Change Control Plan(PCCP)

    FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices.

    SaMD & AI/ML DevicesSoftware Team Onboarding
    Software & AI
    Software in a Medical Device(SiMD)

    Software embedded in or required to operate a hardware medical device.

    SaMD & AI/ML Devices · adjacentSoftware Team Onboarding · adjacent
    Software & AI
    Clinical Decision Support(CDS)

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

    SaMD & AI/ML DevicesSoftware Team Onboarding
    Standards
    IEC 62304

    Lifecycle requirements for medical device software.

    SaMD & AI/ML DevicesSoftware Team Onboarding
    Standards
    ISO 14971

    International standard for the application of risk management to medical devices.

    Cybersecurity
    Premarket Cybersecurity Submission

    The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    IMDRF·1FDA·2
    1. 1
      IMDRF SaMD
      Verified
      IMDRFimdrf.org
    2. 2
      FDA SaMD Resources
      Verified
      FDAfda.gov
    3. 3
      FDA - AI/ML-Enabled Medical Devices
      Verified
      FDAfda.gov

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