EUA (Emergency Use Authorization) is una vía de autorización de emergencia de la FDA que permite el uso de productos médicos no aprobados durante emergencias de salud pública cuando no existen alternativas aprobadas adecuadas.
Complete Guide to EUA
Emergency Use Authorization (EUA) is a mechanism established under Section 564 of the Federal Food, Drug, and Cosmetic Act that allows the FDA to facilitate the availability and use of medical countermeasures during public health emergencies.
When EUA can be issued:
- Emergency declaration by HHS Secretary
- No adequate alternatives exist
- Known and potential benefits outweigh known and potential risks
- Evidence of effectiveness (lower standard than full approval)
EUA vs. traditional pathways:
- 510(k): Requires substantial equivalence to predicate device
- PMA: Requires extensive clinical data proving safety and effectiveness
- EUA: Requires evidence that benefits may outweigh risks during emergency
COVID-19 EUA experience:
The pandemic demonstrated EUA's importance:
- Diagnostics: Over 400 COVID-19 tests authorized
- Therapeutics: Remdesivir, monoclonal antibodies, antivirals
- Vaccines: Pfizer, Moderna, J&J vaccines (later transitioned to BLA approval)
- Medical devices: Ventilators, PPE, pulse oximeters
EUA requirements for medical devices:
1. Letter of authorization request to FDA
2. Evidence supporting safety and effectiveness
3. Manufacturing information and facilities
4. Proposed labeling and fact sheets
5. Risk-benefit analysis
Post-EUA requirements:
- Periodic reporting on safety and performance
- Compliance with conditions of authorization
- Notification of changes to device or manufacturing
- Post-market surveillance activities
Transition from EUA to regular approval:
Manufacturers typically pursue:
- 510(k) clearance for lower-risk devices
- De Novo classification for novel low-moderate risk devices
- PMA approval for high-risk devices
EUA termination:
- Emergency declaration ends
- FDA revokes based on new evidence
- Manufacturer withdraws authorization
- Regular approval obtained (transition period allowed)
Key limitation: EUA products must include statement "This product has not been approved or cleared by FDA" and can only be used during the declared emergency unless transitioned to regular approval.
Related Terms
More Submission Types
View allUna presentación previa a la comercialización ante la FDA para demostrar que un dispositivo médico es sustancialmente equivalente a un dispositivo predicado comercializado legalmente.
Una vía de presentación simplificada de 510(k) de la FDA que se basa en documentos de orientación de la FDA, controles especiales o estándares de consenso reconocidos para demostrar la equivalencia sustancial.
Una designación del programa FDA para dispositivos médicos que proporcionan un tratamiento o diagnóstico más efectivo de enfermedades o condiciones potencialmente mortales o irreversiblemente debilitantes.
Una vía regulatoria de la FDA para dispositivos médicos novedosos de riesgo bajo a moderado que no tienen un dispositivo predicado para comparación 510(k).
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