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類別: CLINICAL
研究用器材豁免(IDE)
FDA批准允許研究用器材在臨床研究中使用以收集安全性和有效性數據。在美國開始臨床試驗前，重大風險器材需要IDE。
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 研究用器材豁免(IDE) across 27 authorities in real time.
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