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    RegulatoryRegulated PathwaysIFU (statement)

    Indications for Use

    Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate.

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

    Definition

    The Indications for Use statement is a specific statement of disease, condition, or anatomical site for which a device is intended, including the patient population.

    What this means in practice

    Indications for Use is a specific, regulatorily significant subset of intended use, captured in 510(k) and PMA decision summaries.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·1European Commission·1IMDRF·1
    1. 1
      FDA Indications Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

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