Saturday, June 8, 2013

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).*
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.
* Note that the Secretary’s determination and declaration were issued based on revised authorities under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
Diagnostic TestDateLetter of
Fact Sheet for Healthcare ProvidersFact Sheet for PatientsLabeling (PDF)
CDC Novel Coronavirus 2012 Real-time RT-PCR Assay6/5/13[Authorization][Healthcare][Patients][Labeling]

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