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CATÉGORIE: REGULATORY PATHWAYS

Autorisation d'utilisation d'urgence (EUA)

Un mécanisme FDA permettant l'utilisation de produits non approuvés lors d'urgences de santé publique.

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

  1. Confirm an applicable emergency declaration and EUA eligibility.
  2. Submit EUA request with available safety/effectiveness and manufacturing data.
  3. Comply with EUA conditions (labeling, fact sheets, reporting).
  4. 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

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TERMES CONNEXES

Clearance 510(k)Approbation pré-commercialisation (PMA)