← All terms
CATEGORY: REGULATORY PATHWAYS
Emergency Use Authorization (EUA)
An FDA mechanism that allows use of unapproved medical products during public health emergencies. EUA enables faster access to critical devices (e.g., diagnostic tests, ventilators) when the normal approval process would be too slow.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to Emergency Use Authorization (EUA) across 27 authorities in real time.
START FREE →