Emergency Use Authorization
Emergency Use Authorization (EUA) information, and list of all current EUAs
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow 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 there are no adequate, approved, and available alternatives.
Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.
Guidance
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.
Questions & Answers
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.
Emergency Diagnostics Information
- Emergency Use Authorizations (current device EUAs)
- How to Submit a Pre-EUA for In vitro Diagnostics (IVDs) to FDA (for test manufacturers)
- Information for Laboratories Implementing IVD Tests Under EUA
Current EUAs
The tables below provide information on current EUAs:
- Anthrax EUAs
- Ebola Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- Freeze Dried Plasma Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Nerve Agent EUA Information
- Novel coronavirus (2019-nCoV)
- Zika Virus EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
Anthrax EUAs
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.
Ebola Virus EUA Information
Ebola preparedness and response updates from FDA (all agency activities)
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
Ebola Diagnostic Tests with De Novo, 510(k) or PMA
- OraQuickEbola Rapid Antigen Test - On October 10, 2019, FDA allowed marketing (PDF, 255 KB) of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for Ebola virus disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed. Also see the FDA news release: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens
The OraQuick Ebola Test was reviewed under the De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. Along with this marketing authorization, the FDA is establishing criteria, called special controls, that determine the requirements for demonstrating accuracy, reliability and effectiveness of tests intended to identify Ebola virus antigens. These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
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EZ1 Real-time RT-PCR Assay |
August 5, 2014 (initial issuance) October 10, 2014 (reissuance)
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Authorization (PDF, 61 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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CDC Ebola Virus NP Real-time RT-PCR Assay |
October 10, 2014 (initial issuance) March 2, 2015 (reissuance) October 8, 2019 (amended)
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Authorization (PDF, 282 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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CDC Ebola Virus VP40 Real-time RT-PCR Assay |
October 10, 2014 (initial issuance) March 2, 2015 (reissuance) October 8, 2019 (amended)
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Authorization (PDF, 285 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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FilmArray NGDS BT-E Assay |
October 25, 2014 (initial issuance) March 2, 2015 (reissuance)
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Authorization (PDF, 326 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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FilmArray Biothreat-E test |
October 25, 2014 November 12, 2019 (amended) |
Authorization (PDF, 73 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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RealStar Ebolavirus RT-PCR Kit 1.0 |
November 10, 2014 (initial issuance) November 26, 2014 (reissuance)
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Authorization (PDF, 263 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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LightMix Ebola Zaire rRT-PCR Test |
December 23, 2014 |
Authorization (PDF, 2.2 MB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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Xpert Ebola Assay |
March 23, 2015 |
Authorization (PDF, 240 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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Idylla Ebola Virus Triage Test (Biocartis NV) |
May 26, 2016 |
Authorization (PDF, 321 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
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DPP Ebola Antigen System (Chembio Diagnostic Systems, Inc.) |
November 9, 2018 April 2, 2019 (amended) |
Authorization (PDF, 103 KB) Letter Granting EUA Amendment(s) (PDF, 87 KB) |
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Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 4, 2014) |
Enterovirus D68 (EV-D68) EUA Information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) |
May 12, 2015 |
Authorization (PDF, 229 KB) |
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Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) |
Freeze Dried Plasma Information
Also see FDA News Release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product (July 10, 2018)
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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Pathogen-Reduced Leukocyte-Depleted Freeze Dried Plasma (Centre de Transfusion Sanguine des Armées)
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July 9, 2018 |
Authorization (PDF, 203 KB) |
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Determination by DoD (June 7, 2018) Declaration Regarding Emergency Use of Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat (July 9, 2018) |
H7N9 Influenza EUA Information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheet and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay |
April 22, 2013 (initial issuance)
March 27, 2018 (reissuance) |
Authorization (PDF, 301 KB), re-issued March 27, 2018
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Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
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Quidel Lyra Influenza A Subtype H7N9 Assay |
February 14, 2014 |
Authorization (PDF, 57 KB) |
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Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
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A/H7N9 Influenza Rapid Test |
April 25, 2014 |
Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) |
Pandemic Influenza Medical Countermeasures-Amendment (The amendment of the October 10, 2008, declaration as amended June 11, 2009, the December 17, 2008, declaration and February 29, 2012, declaration is effective as of January 1, 2016.) |
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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CDC Novel Coronavirus 2012 Real-time RT-PCR Assay |
June 5, 2013 (initial issuance) June 10, 2014 (reissuance)
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Authorization (PDF, 2.2 MB) |
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RealStar MERS-CoV RT-PCR Kit U.S. |
July 17, 2015 February 12, 2016 (reissuance)
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Authorization (PDF, 238 KB) |
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Nerve Agent EUA Information
On July 9, 2018, FDA approved (PDF, 49 KB) the 2 mg Atropine Auto-Injector manufactured by Rafa Laboratories, Ltd., for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). For more information about the approved 2 mg Rafa Atropine Auto-Injector, see the product label (PDF, 482 KB). The EUA detailed in the table below is still in effect.
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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Atropine Auto-Injector (Rafa Laboratories Ltd.) |
April 11, 2017 (initial issuance) May 23, 2017 (amended) January 24, 2018 (amended) March 6, 2018 (amended) May 15, 2018 (amended) |
Letter of Authorization (PDF, 514 KB) Letter granting EUA amendment(s) (PDF, 28 KB) 2nd letter granting EUA amendment(s) (PDF, 33 KB) 3rd letter granting EUA amendment(s) (PDF, 85 KB) 4th letter granting EUA amendment(s) (PDF, 42 KB) |
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Determination and Declaration Regarding Nerve Agent or Certain Insecticide (Organophosphorus and/or Carbamate) Poisoning (April 11, 2017) |
Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (April 11, 2017) |
Novel coronavirus (2019-nCoV) EUA Information
Novel coronavirus (2019-nCoV) updates from FDA
FDA requests that diagnostic test sponsors interested in potential EUA for tests to detect 2019-nCoV contact mailto:CDRH-EUA-Templates@fda.hhs.gov for further information and templates. Also see: How to Submit a Pre-EUA for In vitro Diagnostics to FDA
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Manufacturer Instructions/Package Insert | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
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CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (CDC) |
February 4, 2020 |
Letter of Authorization (PDF, 286 KB) |
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(February 4, 2020) |
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Zika Virus EUA Information
Zika virus response updates from FDA
Zika virus diagnostic development information
For more information about the diagnostics below, also see Emergency Use Authorizations (current device EUAs).
Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.
Zika Diagnostic Tests with De Novo, 510(k), or PMA
- ZIKV Detect 2.0 IgM Capture ELISA - On May 23, 2019, FDA authorized marketing (PDF, 175 KB) of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s EUA authority. Also see the FDA news release: FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
- ADVIA Centaur Zika test – On July 17, 2019, FDA cleared the ADVIA Centaur Zika test. This is the second Zika diagnostic test FDA has allowed to be marketed in the U.S. for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
- LIAISON XL Zika Capture IgM Assay II – On October 28, 2019, FDA cleared the LIAISON XL Zika Capture IgM Assay II for detecting Zika virus IgM antibodies. Previously, the test had been authorized only for emergency use under FDA’s EUA authority.
| Medical Product | Date of EUA Issuance | Letters | Federal Register Notice for EUA |
Fact Sheets and Manufacturer Instructions/Package Insert |
EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
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CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay |
February 26, 2016 (initial issuance) June 29, 2016 (amended) November 15, 2016 (amended) December 6, 2016 (amended) May 3, 2017 (amended) July 31, 2017 (amended) April 16, 2018 (amended) September 26, 2018 (amended) |
Letter granting EUA amendment(s) (PDF, 155 KB) Letter granting EUA amendment(s) (PDF, 123 KB) Letter granting EUA amendment(s) (PDF, 110 KB) Letter granting EUA amendment(s) (PDF, 113 KB) Letter granting EUA amendment(s) (PDF, 131 KB) Letter granting EUA amendment(s) (PDF, 131 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) |
March 17, 2016 (initial issuance) September 21, 2016 (amended) January 12, 2017 (amended) February 28, 2017 (amended) April 6, 2017 (amended) |
Authorization (PDF, 82 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF, 223 KB) Letter granting EUA amendment(s) (PDF, 126 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika Virus RNA Qualitative Real-Time RT-PCR (Quest Diagnostics Infectious Disease, Inc.) |
April 28, 2016 (initial issuance) October 7, 2016 (reissuance) April 11, 2017 (amended) |
Authorization (PDF, 339 KB) Letter granting EUA amendment(s) (PDF, 126 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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RealStar Zika Virus RT-PCR Kit U.S. (altona Diagnostics GmbH) |
May 13, 2016 (initial issuance) October 31, 2016 (amended) March 6, 2017 (amended) |
Authorization (PDF, 342 KB) Letter Granting EUA Amendment(s) (PDF, 130 KB) Letter Granting EUA Amendment(s) (PDF, 130 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Aptima Zika Virus assay (Hologic, Inc.) |
June 17, 2016 (initial issuance) September 7, 2016 (amended) April 12, 2017 (amended) March 8, 2018 (amended)
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Authorization (PDF, 305 KB) Letter granting EUA amendment(s) (PDF, 126 KB) Letter granting EUA amendment(s) (PDF, 124 KB) Letter granting EUA amendment(s) (PDF, 130 KB)
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika Virus Real-time RT-PCR Test (Viracor Eurofins) |
July 19, 2016 (initial issuance) February 28, 2017 (amended) |
Authorization (PDF, 334 KB) Letter granting EUA amendment(s) (PDF, 124 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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VERSANT Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.) |
July 29, 2016 (initial issuance) December 19, 2016 (amended) |
Authorization (PDF, 78 KB) Letter granting EUA amendment(s) (PDF, 124 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Sentosa SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.) |
September 23, 2016 |
Authorization (PDF, 355 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika Virus Detection by RT-PCR Test (ARUP Laboratories) |
September 28, 2016 |
Authorization (PDF, 98 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Abbott RealTime ZIKA (Abbott Molecular Inc.) |
November 21, 2016 (initial issuance) January 6, 2017 (amended) |
Authorization (PDF, 84 KB) Letter granting EUA amendment(s) (PDF, 150 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Zika ELITe MGB Kit U.S. (ELITechGroup Inc. Molecular Diagnostics) |
December 9, 2016 |
Authorization (PDF, 312 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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Gene-RADAR Zika Virus Test (Nanobiosym Diagnostics, Inc.) |
March 20, 2017 |
Authorization (PDF, 313 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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TaqPath Zika Virus Kit (Thermo Fisher Scientific) |
August 2, 2017 |
Authorization (PDF, 292 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016)
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CII-ArboViroPlex rRT-PCR Assay (Columbia University) |
August 11, 2017 |
Authorization (PDF, 377 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
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September 27, 2017 (initial issuance) February 6, 2018 (amended) August 3, 2018 (amended) |
Authorization (PDF, 424 KB) Letter granting EUA amendment(s) (PDF, 130 KB) Letter granting EUA amendment(s) (PDF, 129 KB) |
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Emergency Use of In Vitro Diagnostic Tests for Detection of Zika Virus and/or Diagnosis of Zika Virus Infection (February 26, 2016) |
Related Links
- Summary of Process for EUA Issuance
- Emergency Use Authorization--Archived Information
- Emergency Dispensing Orders
- 21st Century Cures Act: MCM-Related Cures Provisions
- Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
- Public Readiness and Emergency Preparedness (PREP) Act
- HHS Public Health Emergency EUA Authorization Declarations
- Ebola Preparedness and Response Updates from FDA
- Zika Virus Response Updates from FDA
- Emergency Use Authorizations (Medical Devices)
- Historical Information about Device Emergency Use Authorizations