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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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Emergency Use Authorization

Vials of flu vaccine

Skip to list of 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 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Information about EUAs that are no longer in effect is available on our EUA archive page.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)
DoD EZ1 Real-time RT-PCR Assay

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

October 10, 2014  

Authorization (PDF, 57 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
CDC Ebola Virus VP40 Real-time RT-PCR Assay

October 10, 2014  

Authorization (PDF, 57 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
BioFire Defense FilmArray NGDS BT-E Assay

October 25, 2014  

Authorization (PDF, 133 KB) Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola Virus (August 12, 2014) 
BioFire Defense FilmArray Biothreat-E test

October 25, 2014  

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

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

 

November 10, 2014 (initial issuance)

Authorization (PDF,  263 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).

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). 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.

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.

Additional information on 2014 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)

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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

 

Medical ProductDate of EUA IssuanceLetter of AuthorizationFederal Register Notice for EUA Fact Sheets and LabelingEUA Determination and Declaration PREP Act Declaration (if applicable) 
Oral formulations of doxycycline products for the post-exposure prophylaxis (PEP) of inhalational anthrax

October 14, 2011

 

(originally issued on October 6, 2008, with subsequent amendments)

Amendment to the Letter of Authorization (October 14, 2011) (PDF, 7 MB)


Amendment to the Letter of Authorization (August 23, 2010) (PDF, 2 MB)
 

Amended EUA for doxycycline hyclate tablet for USPS as part of the National Postal Model (November 28, 2011)
 

 

EUA for Pre-event Provision of Potential Use of Doxycycline for Inhalation Anthrax (October 21, 2008)
 

Interim Questions and Answers: Emergency Use Authorization for Oral Formulations of Doxycycline for Post-Exposure Prophylaxis of Inhalational Anthrax

Determination and Declaration – Federal Register (July 5, 2013)


Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information – Federal Register (October 6, 2008)
 

(also see Determination)


Renewal of Declaration Regarding Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information – Federal Register (July 6, 2012)
 

 

Renewal of Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information and Amendment To Include All Oral Formulations of Doxycycline – Federal Register (July 27, 2011)


Renewal of Declaration ...(October 5, 2010)


Renewal of Declaration ...(October 6, 2009)
 

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