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类别: CLINICAL

研究用器械豁免(IDE)

FDA批准允许研究用器械在临床研究中使用以收集安全性和有效性数据。在美国开始临床试验前，重大风险器械需要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

  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

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相关术语

研究用器械上市前批准(PMA)临床调查