--- title: "EUA, Emergency Use Authorization | MedTech Terms" description: "FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eua#term", "name": "Emergency Use Authorization", "alternateName": "EUA", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Emergency Use Authorization [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)EUA # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/labeling), Fact Sheets for Healthcare Providers and for Recipients, [adverse event](/terms/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](/terms/de-novo), [PMA](/terms/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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report) ### More in Regulatory · Same category [ Regulatory 510(k) Summary vs 510(k) Statement Two 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k)[ Regulatory Accreditation Scheme for Conformity Assessment(ASCA) FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny. ](/terms/asca) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 2 European Commission· 1 1. [1 Emergency Use Authorization Verified FDA · fda.gov ](https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization) 2. [2 EUA of Medical Products Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities) 3. [3 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym EUA Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=eua) Learn in 60 seconds Card Lesson Quiz FDA authority to permit the use of unapproved medical products, or unapproved uses of approved products, during declared public health emergencies. - · 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. - · For devices, an EUA is not a clearance or approval, it is a time-limited authorization tied to the declared emergency. Remember this Watch out: Treating EUA as approval, labeling, marketing, and reimbursement implications differ significantly from cleared/approved status. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Premarket Approval(PMA) ](/terms/pma) - [In Vitro Diagnostics(IVD) ](/terms/ivd) - [5-Day Report ](/terms/five-day-report) - [Medical Device Reporting (FDA)(MDR) ](/terms/mdr-reporting) You may also need Auto-suggested from Regulatory and shared keywords. - [Section 522 Postmarket Surveillance(Section 522) ](/terms/section-522) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Pharmaceuticals and Medical Devices Agency(PMDA) ](/terms/pmda) - [Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [IDE Annual Progress Report ](/terms/ide-annual-report) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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