2013 H7N9 Influenza Emergency Use Authorizations (Updated Information)

By Effective Medicine  On  In Medical Devices Tagged  

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)
  • 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency)
  • Historical Information about 2009 H1N1 Influenza Emergency Use Authorizations
  • Termination Letters and Additional Information

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) for the CDC Novel Coronavirus 2012 Real-time RT-PCR Assay. This test is for the presumptive detection of Middle East Respiratory Syndrome Coronavirus (MERS-CoV), formerly known as Novel Coronavirus 2012 or NCV-2012, in patients with signs and symptoms of MERS-CoV infection in conjunction with clinical and epidemiological risk factors.   This device will be distributed by CDC to qualified laboratories.

 

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 Lyraâ„¢ 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 Lyraâ„¢ Influenza A Subtype H7N9 Assay
2/14/14
[Authorization]
[Healthcare]
[Patients]
[Labeling]
A/H7N9 Influenza Rapid Test
4/25/14
[Authorization]
[Healthcare]
[Patients]
[Labeling]

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)

 

In Vitro Diagnostics (IVD)

Test
Date**
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 reagents
5/2/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
CDC rRT-PCR Swine Flu Panel on the Joint Biological Agent Identification and Diagnostic System (JBAIDS) Instrument
12/18/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
CDC Swine Influenza Virus Real-time RT-PCR Detection Panel
12/18/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Cepheid Xpert® Flu A Panel for the Diagnosis of 2009 H1N1 Influenza Virus Infection
12/24/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Diagnostic Hybrids, Inc. D3 Ultra 2009 H1N1 Influenza A Virus ID Kit
2/16/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Diatherix 2009 H1N1 Test
10/9/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR Test
2/1/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Focus Diagnostics Influenza A H1N1 (2009) Real-Time RT-PCR
12/18/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Focus Diagnostics Simplexaâ„¢ Influenza A H1N1 (2009) Test
12/18/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
GeneSTAT 2009 A/H1N1 Influenza Test
12/9/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay from IntelligentMDx
3/22/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
IQuum Liatâ„¢ Influenza A/2009 H1N1 Assay
5/4/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay
3/23/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Prodesse ProFlu-ST Influenza A assay for the diagnosis of 2009 H1N1 Influenza virus infection
10/27/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Qiagen artus® Inf. A H1N1 2009 LC RT-PCR Kit
3/11/10
[Authorization]
[Healthcare]
[Patients]
[Labeling]
Roche RealTime ready Influenza A/H1N1 Test
11/13/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
TessArray Resequencing Influenza A Microarray Detection Panel
12/16/09
[Authorization]
[Healthcare]
[Patients]
[Labeling]
ViraCor 2009 H1N1 Influenza A Real-time RT-PCR
1/21/10
[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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