← Tous les termes
CATÉGORIE: CLINICAL
Exemption pour dispositif expérimental (IDE)
Une approbation FDA permettant l'utilisation d'un dispositif expérimental dans une étude clinique.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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 Exemption pour dispositif expérimental (IDE) across 27 authorities in real time.
START FREE →