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    Instructions for Use

    Information supplied by the manufacturer to inform the user of safe use of a device.

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

    Definition

    Instructions for Use (IFU) provide directions necessary for users to safely and effectively use a medical device, including indications, contraindications, warnings, precautions, and operating instructions.

    What this means in practice

    IFU content is regulated by FDA labeling requirements (21 CFR Part 801) and EU MDR Annex I. Cybersecurity-relevant information must increasingly be included for connected devices.

    Mentioned in recent activity

    2 entries

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1FDA·1European Commission·1
    1. 1
      21 CFR Part 801
      Verified
      eCFRecfr.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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