Emergency Use Authorization
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
In April 2016, FDA issued a new Draft Guidance for Industry and Public Health Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016. For more information, please see the April 4, 2016 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.
Current EUAs
The tables below provide information on current EUAs:
- Zika Virus EUA Information
- Enterovirus D68 (EV-D68) EUA Information
- Ebola Virus EUA Information
- H7N9 Influenza EUA Information
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
- Doxycycline Mass Dispensing EUA Information
- National Postal Model Anthrax EUA Information
Information about EUAs that are no longer in effect is available on our EUA archive page.
Zika Virus EUA Information
Zika virus diagnostic development information
Draft EUA review templates for Zika are available by email request to: CDRH-ZIKA-Templates@fda.hhs.gov
Enterovirus D68 (EV-D68) EUA Information
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Labeling | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) | May 12, 2015 | Authorization (PDF, 229 KB) | FR notice |
| Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 (February 6, 2015) |
Ebola Virus EUA Information
Additional information on 2014-2015 Ebola virus EUAs (diagnostics)
Ebola response updates from FDA (all agency activities)
* 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 EZ1 Real-time RT-PCR 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 notice) more
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 November 3, 2016, FDA amended and reissued the Emergency Use Authorization (EUA) to transfer ownership of the ReEBOV™ Antigen Rapid Test EUA from Corgenix Inc. to Zalgen Labs, LLC. The amended EUA allows Zalgen Labs, LLC and its authorized distributors to distribute the ReEBOV™ Antigen Rapid Test manufactured by Corgenix Inc. and, upon subsequent concurrence by FDA, to distribute the ReEBOV™ Antigen Rapid Test manufactured by Zalgen Labs, LLC (or an authorized contract manufacturer), subject to the conditions of authorization set forth in the Authorization Letter. The authorized Fact Sheet for Health Care Providers (PDF, 59 KB), the authorized Fact Sheet for Patients (PDF, 95 KB), and the authorized Instructions for Use (PDF, 328 KB)have been updated to incorporate the 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.
On July 31, 2015, FDA issued an EUA to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the presumptive detection of Ebola Zaire virus in venipuncture whole blood or fingerstick whole blood specimens 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), by laboratories and facilities adequately equipped, trained, and capable of testing for Ebola infection (including treatment centers and public health clinics). The test may also detect antigens from Sudan Ebola virus and Bundibugyo Ebola virus; however, it does not distinguish between these different Ebola virus species. The OraQuick® Ebola Rapid Antigen Test is intended for circumstances when the use of a rapid Ebola virus test is determined to be more appropriate than the use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. The OraQuick® Ebola Rapid Antigen Test is not intended for use for general Ebola virus infection screening, such as airport screening or contact tracing of individuals without signs and symptoms of Ebola infection.
On March 4, 2016, FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the OraQuick® Ebola Rapid Antigen Test for the detection of Ebola Zaire virus in cadaveric oral fluid swab specimens from individuals with epidemiological risk factors for Ebola virus infection and suspected to have died of Ebola. The test is intended to aid in diagnosing Ebola Zaire virus infection as the cause of death in order to inform decisions on safe and dignified burial procedures to prevent transmission of Ebola virus in the community. The OraQuick® Ebola Rapid Antigen Test for use with cadaveric oral fluid is not intended for use with oral fluid specimens from living individuals.
On September 26, 2016, FDA concurred with the modification of the Labeling (Instructions for Use) of the OraQuick® Ebola Rapid Antigen Test - For Use with Cadaveric Oral Fluid under the emergency use authorization issued on March 4, 2016. The Labeling has been updated to include additional performance data ((1) LoD with cadaveric oral fluid; (2) interference testing with oral fluid and (3) additional cross reactivity data) to comply with condition Q in the original Authorization Letter from March 4, 2016.
On May 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Idylla™ Ebola Virus Triage Test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the Idylla™ Instrument System (Idylla™ System) in EDTA venous whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors. The Idylla™ Ebola Virus Triage Test should be performed by laboratories in CLIA moderate and high complexity laboratories in the U.S. or in similarly qualified non-U.S. laboratories, by clinical laboratory personnel who have received specific training on the use of the Idylla™ Ebola Virus Triage Test on the Idylla™ System. Additional technical information.
H7N9 Influenza EUA Information
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheet and Labeling | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| A/H7N9 Influenza Rapid Test | April 25, 2014 | Authorization | FR notice | 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 (December 9, 2015) | |
| Quidel Lyra™ Influenza A Subtype H7N9 Assay | February 14, 2014 | Authorization (PDF, 57 KB) | FR notice |
| Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) | (same as above) |
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay | April 22, 2013 | Authorization (PDF, 78 KB) | FR notice |
| Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of the Avian Influenza A (H7N9) Virus (April 19, 2013) | (same as above) |
More information (diagnostics)
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA Information
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Labeling | EUA Determination and Declaration (Effective Date) | PREP Act Declaration (if applicable) |
|---|---|---|---|---|---|---|
| CDC Novel Coronavirus 2012 Real-time RT-PCR Assay | June 10, 2014 (reissuance)
June 5, 2013 (initial issuance) | Authorization (PDF, 2.2 MB) | FR notice |
| ||
| RealStar® MERS-CoV RT-PCR Kit U.S. | February 12, 2016 (reissuance)
July 17, 2015 | Authorization (PDF, 238 KB) | FR notice |
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In response to CDC’s request, 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.
On July 17, 2015, FDA issued an EUA to authorize the emergency use of the RealStar® MERS-CoV RT-PCR Kit U.S. for the in vitro qualitative detection of RNA from the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in lower respiratory specimens (tracheal aspirate/tracheal secretions) from individuals with signs and symptoms of infection with MERS-CoV in conjunction with epidemiological risk factors for the presumptive detection of MERS-CoV, by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and similarly qualified non-U.S. laboratories.
In response to altona Diagnostics GmbH's request to amend this EUA, on February 12, 2016 FDA reissued the July 17, 2015 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. The amendments authorize the expanded use of the RealStar® MERS-CoV RT-PCR Kit U.S. to include the in vitro qualitative detection of genomic RNA from MERS-CoV in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-Co V cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated). The amendments also include a new Fact Sheet for Asymptomatic Individuals Suspected of Exposure to MERS-CoV Cases and revisions to the Instructions for Use, and fact sheets for health care providers and patients.
Doxycycline Mass Dispensing EUA Information*
*Note: Based on the April 13, 2016, issuance of the Doxycycline Emergency Dispensing Order and Doxycycline Emergency Use Instructions (EUI), which replace the need for an EUA for doxycycline mass dispensing, this EUA will be terminated by FDA. Notice of such termination will be published in the Federal Register.
More: current drug information related to anthrax, from the Center for Drug Evaluation and Research
National Postal Model Anthrax EUA Information
| Medical Product | Date of EUA Issuance | Letter of Authorization | Federal Register Notice for EUA | Fact Sheets and Labeling | EUA Determination and Declaration (Effective Date) | 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)
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| Renewal of Declaration ... (July 20, 2012) Renewal of Declaration ... (July 20, 2011) Renewal of Declaration ... (October 1, 2010) Renewal of Declaration ... (October 1, 2009) Determination and Declaration Regarding Emergency Use of Doxycycline Hyclate Tablets Accompanied by Emergency Use Information – Federal Register (October 1, 2008) | Anthrax Medical Countermeasures-Amendment (December 9, 2015)
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Related Links
Summary of Process for EUA Issuance Emergency Use Authorization--Archived Information 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 Response Updates from FDA
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