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    Emergency Use Authorization

    FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed June 20, 2026

    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 the regulation says
    FDA's Emergency Use Authorization authority is at FD&C Act §564 (21 U.S.C. §360bbb-3). HHS Secretary declarations under PHSA §319 or §319F-2 trigger FDA's ability to issue EUAs. FDA issued comprehensive policy in the January 2017 'Emergency Use Authorization of Medical Products and Related Authorities' guidance.

    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.
    Common pitfalls
    • •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.

    Primary references

    3 sources
    Link health: 1 verified 2 bot-blocked· last checked 2026-06-20
    FDA·2European Commission·1
    1. 1
      Emergency Use Authorization
      Bot-blocked
      FDAfda.gov
    2. 2
      EUA of Medical Products Guidance
      Bot-blocked
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

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