Emergency Use Authorization
FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.
Definition
Emergency Use Authorization (EUA) is a mechanism under Section 564 of the Federal Food, Drug, and Cosmetic Act that allows FDA to authorize the use of medical countermeasures (drugs, biologics, devices, diagnostics) during a declared emergency when there is no adequate, approved, available alternative. For devices, an EUA is not a clearance or approval, it is a time-limited authorization tied to the declared emergency. Manufacturers must comply with EUA-specific conditions: required labeling, Fact Sheets for Healthcare Providers and for Recipients, adverse event reporting, recordkeeping, and any conditions FDA imposes.What this means in practice
EUA became broadly familiar through COVID-19, when hundreds of IVDs, ventilators, and PPE products were authorized under EUA. Post-pandemic, EUA remains the standard pathway for medical countermeasures against CBRN threats and emerging infectious disease. Manufacturers should understand the transition pathway: when an EUA is terminated, products typically must either obtain traditional marketing authorization (510(k), De Novo, PMA) or stop being distributed.- •Treating EUA as approval, labeling, marketing, and reimbursement implications differ significantly from cleared/approved status.
- •Underestimating EUA transition planning, when an emergency declaration ends, manufacturers have limited time to obtain conventional authorization or remove product from market.
- •Skipping EUA-specific adverse event reporting requirements, which are stricter than baseline MDR in many cases.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Pathway to classify novel low- to moderate-risk devices that lack a predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm.
More in Regulatory
· Same categoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
Primary references
3 sources- 1
Emergency Use AuthorizationVerifiedFDAfda.gov
- 2
EUA of Medical Products GuidanceVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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