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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 the regulation says
    The FDA, under 21 CFR Part 812, outlines the requirements for an Investigational Device Exemption (IDE). These regulations govern clinical studies conducted to collect safety and effectiveness data on medical devices. The primary goal of an IDE is to permit the interstate shipment of investigational devices for research purposes.

    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.

    Examples

    • A company developing a novel implantable cardiac device applies for a full IDE from the FDA prior to initiating a clinical trial to evaluate its safety and efficacy.
    • A researcher conducting a study on an existing, legally marketed device for a new indication with minimal risk obtains IRB approval and follows abbreviated IDE requirements, without needing explicit FDA IDE approval.
    • A start-up developing a new diagnostic imaging device submits an IDE application to the FDA, detailing the study protocol, device description, and investigator qualifications.
    Common pitfalls
    • •Failing to distinguish between significant risk and non-significant risk device studies can lead to incorrect application of IDE regulations.
    • •Assuming that IRB approval alone is sufficient for all investigational device studies, neglecting FDA IDE requirements.
    • •Not understanding the abbreviated IDE requirements for non-significant risk devices can result in unnecessary administrative burden.
    • •Improperly classifying a device's risk can lead to non-compliance with FDA regulations for clinical investigations.
    • •Beginning a clinical study without proper IDE approval or exemption can result in regulatory action by the FDA.

    Frequently asked questions

    The primary purpose of an Investigational Device Exemption (IDE) is to allow the use of an investigational device in a clinical study to gather safety and effectiveness data needed for regulatory submissions like a Premarket Approval (PMA) or 510(k) to the FDA.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.