← 所有术语
类别: REGULATORY PATHWAYS
同情使用/扩大准入
允许患者在临床试验之外使用研究用医疗器械的途径，适用于无可比较的已批准器械且患者有严重疾病的情况。在美国通过FDA紧急使用授权或扩大准入管理。
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
Compassionate use / expanded access pathways allow patients with serious conditions access to investigational devices outside clinical trials when criteria are met (FDA expanded access; similar national mechanisms elsewhere).
PROCESS / STEPS
- Confirm patient eligibility and lack of satisfactory alternatives.
- Obtain required FDA/IRB (or national) authorizations and informed consent.
- Manufacture and label under investigational controls.
- Report outcomes and adverse events as required; do not use as a marketing substitute.
EXAMPLES
- FDA expanded access for devices may proceed via IDE supplemental pathways for individual patients or intermediate groups.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 同情使用/扩大准入 across 27 authorities in real time.
START FREE →