Medical Devices and Flu Emergencies

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

 

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.

*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).

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]

 

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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 As of June 23, 2010, all of the EUAs have been terminated and this information is no longer current.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 Equipment	Date*	Letter of Authorization	Fact Sheet
Disposable N95 Respirators from Strategic National Stockpile	5/1/09	[Authorization] [Amendment]	[Fact Sheet]

 

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 Simplexa™ 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 Liat™ 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]

* Date of Authorization or of Latest Amendment