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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 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.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    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

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