類別: REGULATORY PATHWAYS

緊急使用授權(EUA)

FDA機制，允許在公共衛生緊急情況下使用未經批准的醫療產品。EUA在正常審批過程過慢時使關鍵器材更快獲得使用。

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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