类别: REGULATORY PATHWAYS

紧急使用授权(EUA)

FDA机制，允许在公共卫生紧急情况下使用未经批准的医疗产品。EUA在正常审批过程过慢时使关键器械（如诊断测试、呼吸机）更快获得使用。

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

Emergency Use Authorization (EUA) is an FDA mechanism during declared emergencies allowing unapproved medical products (or unapproved uses) when certain criteria are met—temporary and distinct from full clearance/approval.

PROCESS / STEPS

Confirm an applicable emergency declaration and EUA eligibility.
Submit EUA request with available safety/effectiveness and manufacturing data.
Comply with EUA conditions (labeling, fact sheets, reporting).
Plan transition to full marketing authorization when emergency ends or as required.

EXAMPLES

Diagnostic tests and certain PPE historically received EUAs during public health emergencies.

RELATED GUIDES & TOOLS

SOURCES

FDA Emergency Use Authorization ↗

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