Medical Devices

Emergency Use Authorizations

This page lists current and terminated Emergency Use Authorizations that make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.


2014 Ebola Virus Emergency Use Authorizations

On September 22, 2006, then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, determined, pursuant to section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. § 247d-6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus, subject to the terms of any authorization issued under 21 U.S.C. § 360bbb-3(a).

On August 5, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the U.S. Department of Defense (DoD) EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in Trizol-inactivated whole blood or Trizol-inactivated plasma specimens from individuals in affected areas 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. This authorization is limited to the use of the authorized EZ1 rRT-PCR Assay on specified instruments by laboratories designated by DoD. In response to DoD’s request to amend this EUA, on October 10, 2014 FDA reissued the August 5, 2014, EUA in its entirety with the DoD-requested amendments incorporated. The amendments authorize the use of the DoD EZ1 rRT-PCR Assay in whole blood or plasma specimens, in addition to Trizol-inactivated whole blood or Trizol-inactivated plasma specimens, from individuals in affected areas 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 DoD. The amendments also include revisions to the Instructions for Use, product insert, and Fact Sheets for Health Care Providers and Patients to address the addition of whole blood and plasma specimens.

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus NP Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from 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 can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization is limited to the use of the authorized CDC Ebola Virus NP Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC.

On October 10, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the Centers for Disease Control and Prevention (CDC) Ebola Virus VP40 Real-time RT-PCR Assay for the in vitro qualitative detection of Ebola Zaire virus in whole blood, serum, and plasma specimens from individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. The CDC Ebola Virus VP40 Real-time RT-PCR Assay can also be used with urine specimens when tested in conjunction with a patient-matched whole blood, serum, or plasma specimen. This authorization is limited to the use of the authorized CDC Ebola Virus NP Real-time RT-PCR Assay on the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR Instrument by qualified laboratories designated by CDC.

On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense LLC FilmArray Biothreat-E test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in whole blood specimens from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.  The FilmArray Biothreat-E test can also be used with urine specimens when tested in conjunction with a patient-matched whole blood specimen. This authorization is limited to the use of the authorized FilmArray Biothreat-E test on only the FilmArray Instrument by CLIA Moderate and High Complexity Laboratories.

On October 25, 2014, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the BioFire Defense LLC FilmArray NGDS BT-E Assay for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in 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.  This authorization is limited to the use of the authorized FilmArray NGDS BT-E Assay on only the FilmArray Instrument by laboratories designated by the United States Department of Defense (DoD).

Diagnostic Test Date Letter of
Authorization (PDF)
Fact Sheet for
Healthcare Providers (PDF)
Fact Sheet
for Patients (PDF)
Labeling
(PDF)
BioFire Defense LLC FilmArray Biothreat-E Test 10/25/14 [Authorization] [Healthcare] [Patients] [Labeling]
BioFire Defense LLC FilmArray NGDS BT-E Assay 10/25/14 [Authorization] [Healthcare] [Patients] [Labeling]
DoD EZ1 Real-time RT-PCR Assay 10/10/14 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Ebola Virus NP Real-time RT-PCR Assay 10/10/14 [Authorization] [Healthcare] [Patients] [Labeling]
CDC Ebola Virus VP40 Real-time RT-PCR Assay 10/10/14 [Authorization] [Healthcare] [Patients] [Labeling]

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2013 Coronavirus Emergency Use Authorization (Potential Emergency)

On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the Middle East respiratory syndrome coronavirus (MERS-CoV). http://www.phe.gov/emergency/news/healthactions/phe/Pages/mers-cov.aspx

On June 5, 2013, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors by qualified laboratories.  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 (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated as part of a public health investigation).  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.

Diagnostic Test Date Letter of
Authorization (PDF)
Fact Sheet for Healthcare Providers Fact Sheet for Patients Fact Sheet for Contacts (PDF) Labeling (PDF)
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay 6/10/14 [Authorization] [Healthcare] [Patients] [Contacts] [Labeling]

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2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency)

On April 19, 2013 Secretary Kathleen Sebelius determined that avian influenza A(H7N9) poses a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of this determination the Secretary declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the avian influenza A(H7N9) virus.*
http://www.phe.gov/emergency/news/healthactions/phe/Pages/H7N9-influenza-virus.aspx.

On April 22, 2013, the FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. This device will be distributed by CDC to the public health and other qualified laboratories.

On February 14, 2014, the FDA issued an Emergency Use Authorization (EUA) for the Lyra™ Influenza A Subtype H7N9 Assay manufactured by Quidel Corporation. This test is for the presumptive detection of novel influenza A (H7N9) virus (detected in China in 2013) in patients with signs and symptoms of respiratory infection who have positive specimens for influenza A viral RNA that are determined to be un-subtypable.

On April 25, 2014, the FDA issued an Emergency Use Authorization (EUA) for the "A/H7N9 Influenza Rapid Test" manufactured by Arbor Vita Corporation. This test is for the presumptive detection of the influenza A (H7N9) virus (detected in China in 2013) for use by Department of Defense (DoD) network laboratories in the U.S. and outside the U.S. or other U.S. government laboratories outside the U.S. for patients with signs and symptoms of respiratory infection in conjunction with epidemiological risk factors, or foreign laboratories. It is intended for testing U.S. citizens living and traveling abroad in China and other affected areas and for U.S. military, Department of State, and other U.S. governmental agency personnel stationed and working in China and other affected areas who may potentially be exposed to influenza A (H7N9) virus (detected in China in 2013) or be exposed to individuals who may carry the influenza A (H7N9) virus (detected in China in 2013).

Diagnostic Test Date Letter of
Authorization
Fact Sheet for Healthcare Providers Fact Sheet for Patients Labeling (PDF)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay 4/22/13 [Authorization] [Healthcare] [Patients] [Labeling]
Quidel Lyra™ Influenza A Subtype H7N9 Assay 2/14/14 [Authorization] [Healthcare] [Patients] [Labeling]
A/H7N9 Influenza Rapid Test 4/25/14 [Authorization] [Healthcare] [Patients] [Labeling]

*Note that Secretary’s determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).

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Page Last Updated: 10/27/2014
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