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.


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 TestDateLetter of
Authorization (PDF)
Fact Sheet for Healthcare ProvidersFact Sheet for PatientsFact Sheet for Contacts (PDF)Labeling (PDF)
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay6/10/14[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 TestDateLetter of
Authorization
Fact Sheet for Healthcare ProvidersFact Sheet for PatientsLabeling (PDF)
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay4/22/13[Authorization][Healthcare][Patients][Labeling]
Quidel Lyra™ Influenza A Subtype H7N9 Assay2/14/14[Authorization][Healthcare][Patients][Labeling]
A/H7N9 Influenza Rapid Test4/25/14[Authorization][Healthcare][Patients][Labeling]

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Historical Information about 2009 H1N1 Influenza Emergency Use Authorizations

The information below was authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, all of the EUAs have been terminated and this information is no longer current.

Personal Protective Equipment (PPE)

Personal Protective EquipmentDate*Letter of
Authorization
Fact
Sheet
Disposable N95 Respirators from Strategic National Stockpile5/1/09[Authorization]
[Amendment]
[Fact Sheet]

In Vitro Diagnostics (IVD)

TestDate**Letter of
Authorization
Fact
Sheet for
Healthcare
Providers
Fact
Sheet
for
Patients
Labeling
(PDF)
CDC Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel with additional specimens and reagents5/2/09[Authorization][Healthcare][Patients][Labeling]
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument12/18/09[Authorization][Healthcare][Patients][Labeling]
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel12/18/09[Authorization][Healthcare][Patients][Labeling]
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection12/24/09[Authorization][Healthcare][Patients][Labeling]
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit2/16/10[Authorization][Healthcare][Patients][Labeling]
Diatherix 2009 H1N1 Test10/9/09[Authorization][Healthcare][Patients][Labeling]
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test2/1/10[Authorization][Healthcare][Patients][Labeling]
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR12/18/09[Authorization][Healthcare][Patients][Labeling]
Focus Diagnostics Simplexa™ Influenza A H1N1 (2009) Test12/18/09[Authorization][Healthcare][Patients][Labeling]
GeneSTAT 2009 A/H1N1 Influenza Test12/9/09[Authorization][Healthcare][Patients][Labeling]
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx3/22/10[Authorization][Healthcare][Patients][Labeling]
IQuum Liat™ Influenza A/2009 H1N1 Assay5/4/10[Authorization][Healthcare][Patients][Labeling]
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay3/23/10[Authorization][Healthcare][Patients][Labeling]
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection10/27/09[Authorization][Healthcare][Patients][Labeling]
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit3/11/10[Authorization][Healthcare][Patients][Labeling]
Roche RealTime ready Influenza A/H1N1 Test11/13/09[Authorization][Healthcare][Patients][Labeling]
TessArray Resequencing Influenza A Microarray Detection Panel12/16/09[Authorization][Healthcare][Patients][Labeling]
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR1/21/10[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).

** Date of Authorization or of Latest Amendment

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Page Last Updated: 06/12/2014
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