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    Investigational Device Exemption

    FDA authorization to use an investigational device in a clinical study.

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

    Definition

    An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a PMA or 510(k) submission to FDA.

    What this means in practice

    Significant risk (SR) device studies require an FDA-approved IDE and IRB approval. Non-significant risk (NSR) studies require IRB approval and abbreviated IDE requirements.

    Cross-references

    Used by

    Things that build on this term.

    Precedes

    Comes before in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    eCFR·1ISO·1FDA·1
    1. 1
      21 CFR Part 812
      Verified
      eCFRecfr.gov
    2. 2
      ISO 14155 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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