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    Off-Label Use

    Use of a device for an indication not in its cleared/approved labeling.

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

    Definition

    Physicians may legally use a cleared device off-label in the practice of medicine. Manufacturers may not promote off-label use; doing so risks FDA enforcement and False Claims Act exposure when federal payment is involved.

    What this means in practice

    Common in cardiology, orthopedics, and pediatrics where on-label populations are narrow. Manufacturers may share scientific information consistent with FDA guidance on responsive communications.

    Primary references

    3 sources
    Link health: 1 verified 1 bot-blocked 1 needs review· last checked 2026-05-09
    FDA·1MedTech Europe·1AHRMM·1
    1. 1
      FDA off-label communications guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      MedTech Europe Code of Ethical Business Practice
      Needs review
      MedTech Europemedtecheurope.org
    3. 3
      AHRMM - Healthcare Supply Chain
      Verified
      AHRMMahrmm.org

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