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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

  1. Determine significant vs non-significant risk.
  2. Prepare IDE application and investigational plan.
  3. Obtain IRB approval and informed consent processes.
  4. 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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