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CATEGORY: CLINICAL
Investigational Device Exemption (IDE)
An FDA approval that allows an investigational device to be used in a clinical study to collect safety and effectiveness data. IDE is required for significant risk devices before clinical trials can begin in the US.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
An Investigational Device Exemption allows US clinical studies of significant-risk devices not yet cleared/approved, under IRB and FDA oversight.
PROCESS / STEPS
- Determine significant vs non-significant risk.
- Prepare IDE application and investigational plan.
- Obtain IRB approval and informed consent processes.
- Conduct study with monitoring and AE reporting.
EXAMPLES
- Pivotal trials for novel Class III devices often require FDA IDE approval.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to Investigational Device Exemption (IDE) across 27 authorities in real time.
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