The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.
Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.
Information on terminated and revoked EUAs can be found in archived information.
The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. 247d-6d). The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19.
On May 9, 2023, HHS Secretary Becerra signed the 11th amendment to the declaration under the PREP Act for COVID-19 Medical Countermeasures. The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.
In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.
FDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. Read more about what happens to EUAs when a public health emergency ends.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.
For additional information about COVID-19 vaccines, see:
Note: In the table below, the Additional Information column contains links to information including fact sheets, EUA letters of authorization, regulatory information, decision memos, health care provider information, and Federal Register notices.
Novavax COVID-19 Vaccine, Adjuvanted
For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older
Moderna COVID-19 Vaccine
For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older
On January 31, 2022, FDA approved the Moderna COVID-19 Vaccine, now known as Spikevax, for the prevention of COVID-19.
Pfizer-BioNTech COVID-19 Vaccine
For the prevention of 2019 coronavirus disease (COVID-19) in individuals 6 months and older
On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUA subsequently issued by FDA is listed in the table below this blue box.
COVID-19 convalescent plasma (365KB) (Reissued February 23, 2021, March 9, 2021 and December 28, 2021)
Healthcare Providers (Updated December 28, 2021) (192KB)
View the list Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products, for additional information including letters of authorization, fact sheets, Dear Health Care Provider letters, and additional information about COVID-19 therapeutics.
The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table on the page: Emergency Use Authorizations for Drugs and Non-Vaccine Biological Products.
View the FDA’s COVID-19 Drugs page to see all products approved to treat COVID-19 without any remaining EUA authorized uses.
Revocation notices for COVID-19 drug and biological product EUAs are available at: Emergency Use Authorization--Archived Information.
Information about COVID-19 EUAs for medical devices can be found below and at: Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.
March 24, 2023 - The FDA finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). The guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA’s recommendations for:
The FDA encourages stakeholders to review the two final guidances, attend the webinar noted below, and reach out to the FDA if they have questions. In particular, for manufacturers that are planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).
On the basis of this determination, the HHS Secretary issued three declarations related to medical devices:
For identification of the applicable declaration for each EUA, please see each EUA letter of authorization and/or the corresponding Federal Register notice.
Please see the page In Vitro Diagnostics EUAs for information about in vitro diagnostics EUAs, including templates.
For current SARS-CoV-2 in vitro diagnostic EUAs, see:
On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency. This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020. On September 27, 2022, FDA updated this policy to ensure continued access to tests while encouraging the transition of these important public health tools to traditional premarket review pathways. The updated policy describes the FDA’s intent to review only a small subset of new EUA requests for diagnostic tests and encourages developers of all test types interested in marketing authorization to pursue authorization through the de novo classification or 510(k) clearance pre-market review pathways.
CDC has granted a right of reference to the performance data contained in CDC's EUA (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.
Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.
For a list of all molecular SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product codes QOF and QQX in FDA’s medical devices databases for 510(k) and De Novo. For a list of all antigen SARS-CoV-2 diagnostic tests that have been cleared or granted De Novo classification, see devices with product code QVF in FDA’s medical devices databases for 510(k) and De Novo. For a list of all SARS-CoV-2 serology tests that have been cleared or granted De Novo classification, see devices with product code QVP in FDA’s medical devices databases for 510(k) and De Novo.
Please see the page Personal Protective Equipment EUAs for current EUAs.
See Revoked EUAs for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and Decontamination and Bioburden Reduction Systems below for information about June 30, 2021 EUA revocations.
Please see the following pages for EUA templates and additional information about other types of medical device EUAs for COVID-19:
On June 30, 2021, the FDA announced the revocation of the following EUAs:
As of the effective date of the revocations, these devices will no longer be authorized for use by health care personnel in health care settings.
On November 28, 2022, the World Health Organization announced, and the U.S. government supported, renaming monkeypox disease to mpox. In response to this action by the WHO, federal public health agencies will adopt the mpox name in correspondence with the medical community and American public from this point forward.
Effective August 9, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:
Vaccine EUAs subsequently issued by FDA are listed in the table below.
PREP Act declaration: Effective September 28, 2022, the HHS Secretary amended the declaration first issued on October 10, 2008, and amended and republished effective January 1, 2016 for smallpox countermeasures and countermeasures against other orthopoxviruses pursuant to section 319F-3 of the Public Health Service Act to emphasize that the declaration applies to monkeypox virus, to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox (variola virus), monkeypox virus, and other orthopoxviruses in a declared emergency, and to extend the duration of the declaration. About PREP Act declarations
Healthcare Providers (343KB) (updated August 16, 2022)
Effective September 7, 2022, pursuant to section 564 of the FD&C Act, the HHS Secretary declared:
Diagnostic EUAs subsequently issued by FDA are listed in the table on this page: Monkeypox Emergency Use Authorizations for Medical Devices.
Additional information for product developers is available at:
Note that FDA previously cleared real-time polymerase chain reaction (PCR) tests that detect non-variola orthopoxvirus DNA, including the virus that causes mpox. Learn more about these tests: Monkeypox Tests (In Vitro Diagnostic (IVD) Devices).
On October 20, 2022, FDA also published lists of certain laboratories that have notified FDA of their laboratory developed monkeypox diagnostic test (LDT), modification to an FDA-cleared or EUA-authorized monkeypox diagnostic test, or laboratory developed monkeypox serology test, as described in Sections IV.A.2, IV.A.3, and IV.C, respectively, of the Policy for Monkeypox Tests to Address the Public Health Emergency. While FDA has not reviewed the laboratory’s validation of the listed tests and has not issued EUAs for these tests, we are providing this information to promote transparency.
For additional information about monkeypox (mpox), see: FDA mpox Response and Monkeypox and Medical Devices.
The tables below provide information on current EUAs:
Information about EUAs that are no longer in effect is available on our EUA archive page.
The 2016 FDA Doxycycline Emergency Dispensing Order and CDC Doxycycline Emergency Use Instructions (EUI) together replace the need for the doxycycline mass dispensing EUA (issued on July 21, 2011). Therefore, the doxycycline emergency dispensing order and EUI should be used by stakeholders for anthrax preparedness and response instead of the mass dispensing EUA.
The July 21, 2011, doxycycline mass dispensing EUA, and the October 14, 2011, National Postal Model anthrax EUA will be terminated by FDA, and notice of such termination will be published in the Federal Register. For additional information, see Emergency Use Authorization--Archived Information.
For more information about the diagnostics below, also see Emergency Use Authorizations for Medical Devices: 2014 Ebola Virus Emergency Use Authorizations.
EZ1 Real-time RT-PCR Assay
(DoD)
August 5, 2014 (initial issuance)
October 10, 2014 (reissuance)
CDC Ebola Virus NP Real-time RT-PCR Assay
(CDC)
October 10, 2014 (initial issuance)
March 2, 2015 (reissuance)
October 8, 2019 (amended)
CDC Ebola Virus VP40 Real-time RT-PCR Assay
(CDC)
October 10, 2014 (initial issuance)
March 2, 2015 (reissuance)
October 8, 2019 (amended)
FilmArray Biothreat-E test
(Biofire Defense, LLC)
October 25, 2014
November 12, 2019 (amended)
RealStar Ebolavirus RT-PCR Kit 1.0
(altona Diagnostics, GmbH)
November 10, 2014 (initial issuance)
November 26, 2014 (reissuance)
LightMix Ebola Zaire rRT-PCR Test
(Roche Molecular Systems, Inc.)
December 23, 2014
Xpert Ebola Assay
(Cepheid)
June 13, 2023 (amended)
DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.)
November 9, 2018
April 2, 2019 (amended)
