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    Intended Use

    The objective intent of the manufacturer regarding the use of the device.

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

    Definition

    Intended use is the use for which a product is intended according to the data supplied by the manufacturer in labeling, advertising, and promotional materials.
    What the regulation says
    Under the US FDA, intended use refers to the objective intent of the persons legally responsible for the labeling of devices (21 CFR 801.4). This objective intent is determined by the expressions of the manufacturer or their authorized representative, including labeling claims, advertising, and promotional materials. Similarly, the EU MDR (Regulation (EU) 2017/745) defines intended purpose as the use for which a device is intended according to the data supplied by the manufacturer in the labeling, instructions for use, or promotional materials.

    What this means in practice

    Intended use defines the device, drives classification, and is the anchor for risk analysis and labeling. Off-label promotion is a regulatory violation.

    Examples

    • A manufacturer states their software is intended to assist clinicians in diagnosing melanoma from dermatoscopic images, which defines its intended use.
    • A blood glucose meter is marketed for self-monitoring by individuals with diabetes, establishing its intended use for patient management of a chronic condition.
    • An orthopedic implant
    Common pitfalls
    • •A poorly defined intended use can lead to incorrect device classification, impacting regulatory pathway and submission requirements.
    • •Failing to clearly articulate the intended use can result in inadequate risk management activities, as potential hazards may be overlooked.
    • •Marketing or promoting a device for uses outside its stated intended use constitutes off-label promotion, which is a regulatory violation.
    • •Modifying the intended use of a device without proper regulatory notification or submission can lead to non-compliance and enforcement actions.
    • •Overly broad or vague intended use statements can create ambiguity and make it difficult to demonstrate conformity with essential requirements or safety and performance principles.

    Frequently asked questions

    Intended use describes the general purpose of the device (e.g., to diagnose a condition), while indications for use specify the particular disease or condition the device will diagnose, treat, or prevent, and often include patient populations or anatomical sites.
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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1European Commission·1IMDRF·1
    1. 1
      21 CFR 801.4
      Verified
      eCFRecfr.gov
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

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