Emergency Preparedness and Response

Emergency Use Authorization

Vials of flu vaccine

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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 the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013.

Guidance

FDA developed guidance in 2007 explaining FDA's policies for authorizing the emergency use of medical products under section 564 of the FD&C Act. The guidance is intended to inform industry, government agencies, and FDA staff of FDA's general recommendation and procedures for issuance of EUAs.

Note: The statutory authority discussed in the 2007 EUA guidance has been amended by PAHPRA and is in the process of being updated.

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.  

Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

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Ebola Virus EUA Information

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and Labeling EUA Determination and Declaration PREP Act Declaration (if applicable)
EZ1 Real-time RT-PCR Assay 
(DoD)

October 10, 2014 (*reissuance - see note below)

August 5, 2014 (initial issuance)

Authorization (PDF, 61 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
CDC Ebola Virus NP Real-time RT-PCR Assay 
(CDC)

March 2, 2015 (reissuance)

October 10, 2014 (initial issuance

Authorization (PDF, 282 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
CDC Ebola Virus VP40 Real-time RT-PCR Assay 
(CDC)

March 2, 2015 (reissuance)

October 10, 2014 (initial issuance

Authorization (PDF, 285 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
FilmArray NGDS BT-E Assay 
(Biofire Defense, LLC)

March 2, 2015 (reissuance)

October 25, 2014 (initial issuance

Authorization (PDF, 326 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
FilmArray Biothreat-E test 
(Biofire Defense, LLC)

October 25, 2014  

Authorization (PDF,  73 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
RealStar® Ebolavirus RT-PCR Kit 1.0 
(altona Diagnostics, GmbH)

November 26, 2014 (**reissuance - see note below)  

November 10, 2014 (initial issuance)

Authorization (PDF,  263 KB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
LightMix® Ebola Zaire rRT-PCR Test 
(Roche Molecular Systems, Inc.)

December 23, 2014

Authorization (PDF,  2.2 MB) FR noticeDeclaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
ReEBOV™ Antigen Rapid Test 
(Corgenix, Inc.)

March 16, 2015 (reissuance)

February 24, 2015 (initial issuance)

Authorization (PDF,  54 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
Xpert® Ebola Assay
(Cepheid)

March 23, 2015

Authorization (PDF,  240 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 

* FDA reissued the August 5, 2014, EUA in its entirety (that is, a new EUA was issued to replace the Aug. 5 EUA) on October 10, 2014, to address an amendment to the August 5 EUA requested by DoD. The amendment expands the types of specimens that can be tested using the DoD assay—while the August 5 EUA allowed for Trizol-inactivated whole blood or Trizol-inactivated plasma to be used with the assay, the October 10 EUA allows for whole blood, plasma, Trizol-inactivated whole blood, or Trizol-inactivated plasma specimens to be tested. The August 5 letter of authorization, fact sheets, and instructions for use have all been reissued to reflect the DoD specimen amendment (updated versions are included in the table above).

On October 10, 2014 FDA authorized emergency use of two Centers for Disease Control and Prevention (CDC) diagnostic tests to detect the Ebola Zaire virus in individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay can test for the virus in whole blood, serum, and plasma specimens, and can also be used with urine specimens when tested in conjunction with whole blood, serum, or plasma from the same patient. Use of these tests is limited to qualified laboratories designated by the CDC. (Federal Register noticemore

In response to CDC’s request to amend these EUAs, on March 2, 2015, FDA reissued the October 10, 2014 EUAs in their entirety with the CDC-requested amendment incorporated. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument.  The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments.  The amendments also allow the future use of “other authorized instruments”, of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA.

The BioFire Defense “FilmArray NGDS BT-E Assay” is for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the FilmArray Instrument using whole blood specimens from individuals with signs and symptoms of Ebola virus infection or who are at risk for exposure or may have been exposed to the Ebola Zaire virus (detected in the West Africa outbreak in 2014) in conjunction with epidemiological risk factors, by laboratories designated by the Department of Defense (DoD).

In response to BioFire Defense, LLC’s request to amend this EUA, on March 2, 2015, FDA reissued the October 25, 2014 EUA in its entirety with the BioFire Defense, LLC requested amendment incorporated. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use and Fact Sheet for Health Care Providers have also been updated to incorporate this amendment.  The amendments also allow the future use of “other specimen types” when requested by BioFire Defense, LLC and concurred with by FDA.

The BioFire Defense “FilmArray Biothreat-E test” is for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the FilmArray Instrument in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests and by laboratories certified under CLIA to perform high complexity tests. The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab. Issuance of this EUA follows the August 5, 2014, issuance of the HHS Secretary’s declaration that circumstances exist to justify issuance of EUAs for Ebola diagnostics; the HHS declaration was based on the existing Department of Homeland Security (DHS) Material Threat Determination issued for Ebola virus in 2006.

On November 10, 2014 FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect RNA from Ebola viruses [such as Zaire ebolavirus (including the Zaire ebolavirus strain detected in the West Africa outbreak 2014), Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus, and Reston ebolavirus] in EDTA plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. This authorization is limited to the use of the authorized RealStar® Ebolavirus RT-PCR Kit 1.0 on only specified instruments by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The RealStar® Ebolavirus RT-PCR Kit 1.0 is marketed by altona Diagnostics GmbH, and does not distinguish between the different Ebola virus species or strains. This EUA provides another commercial Ebola diagnostic (in addition to the October 25, 2014 EUA for the BioFire Defense FilmArray Biothreat-E test). Note: Documents related to the November 10, 2014 EUA are now archived.

** In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued (PDF, 263 KB) the November 10, 2014 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments allow, in addition to altona Diagnostics GmbH, distributors that are authorized by altona Diagnostics GmbH to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s). Because this assay may be distributed outside the U.S., the amendments also allow the use of this assay under this EUA, with certain conditions, at non-U.S. laboratories that are similarly qualified as CLIA High Complexity Laboratories. The Instructions for Use (PDF, 634 KB) and Fact Sheet for Health Care Providers (PDF, 81 KB) have also been updated to incorporate these amendments.

On December 23, 2014, the FDA issued an EUA to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease.  The test runs on only specified instruments by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories.

On February 24, 2015, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the ReEBOV™ Antigen Rapid Test for the presumptive detection of Zaire Ebola virus (detected in the West Africa outbreak in 2014), Sudan Ebola virus, and Bundibugyo Ebola virus in fingerstick (capillary) whole blood, venous whole blood and plasma from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors (including geographic locations with high prevalence of Ebola infection).  The authorized ReEBOV™ Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus.  The authorized ReEBOV™ Antigen Rapid Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing.  The ReEBOV™ Antigen Rapid Test is authorized for use in laboratories or facilities adequately equipped, trained, and capable of such testing (including treatment centers and public health clinics).  The ReEBOV™ Antigen Rapid Test does not distinguish between the different Ebola virus strains. Note: Documents related to the Feburary 24, 2015 EUA are now archived.

In response to Corgenix Inc.’s request to amend this EUA, on March 16, 2015 FDA reissued the February 24, 2015 EUA in its entirety with the Corgenix Inc. requested amendments incorporated.  The amendments allow, in addition to Corgenix Inc., distributors that are authorized by Corgenix Inc. to distribute the ReEBOV™ Antigen Rapid Test with certain conditions applicable to such authorized distributor(s).  The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments.

On March 23, 2015, FDA issued an EUA to authorize the emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus on the GeneXpert Instrument Systems in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Xpert® Ebola Assay should be performed in CLIA moderate and high complexity laboratories or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems.

Additional information on 2014-2015 Ebola virus EUAs (diagnostics)

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H7N9 Influenza EUA Information

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheet and Labeling EUA Determination and DeclarationPREP Act Declaration (if applicable) 
A/H7N9 Influenza Rapid TestApril 25, 2014AuthorizationFR notice

Determination and Declaration - FR notice

 

Determination and Declaration - HHS

 
Quidel Lyra™ Influenza A Subtype H7N9 AssayFebruary 14, 2014Authorization (PDF, 57 KB)FR notice(same as above) 

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay
 

April 22, 2013Authorization (PDF, 78 KB)FR notice(same as above) 

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Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
 

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUAFact Sheets and LabelingEUA Determination and DeclarationPREP Act Declaration (if applicable)
CDC Novel Coronavirus 2012 Real-time RT-PCR AssayJune 10, 2014Authorization (PDF, 2.2 MB)FR noticeDetermination and Declaration - HHS (see Determination)

In response to CDC’s request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013 EUA in its entirety with the CDC-requested amendments incorporated.  The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors. The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals. This device will be distributed by CDC to qualified laboratories.

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Doxycycline Mass Dispensing EUA Information

 More: current drug information related to anthrax, from the Center for Drug Evaluation and Research

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 National Postal Model Anthrax EUA Information

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Page Last Updated: 03/24/2015
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