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    IDE Supplement

    Amendment to an approved Investigational Device Exemption for protocol or device changes.

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

    Definition

    An IDE supplement notifies FDA of changes to an approved IDE - including device modifications, protocol amendments, and investigator additions - and may require prior FDA approval depending on significance.

    What this means in practice

    Significant changes (e.g., risk profile, indication, primary endpoint) require approval before implementation; minor changes can be reported in the annual report.

    Cross-references

    Follows

    Comes after in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·1NIH·1ICH·1
    1. 1
      IDE Modifications
      Verified
      FDAfda.gov
    2. 2
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov
    3. 3
      ICH Guidelines
      Verified
      ICHich.org

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