FDA Authorizes Sixth Device to Help in Fight Against Ebola

Regulatory NewsRegulatory News | 14 November 2014 |  By 

The US Food and Drug Administration (FDA) has once again given its blessing to a new diagnostic tool meant to help identify treatments for Ebola—the sixth time it has used its emergency authority to do so in the last four months.


In March 2013, FDA was given a host of new authorities and responsibilities under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a piece of legislation intended to bolster the government's ability to respond to health crises, and especially those of a biological nature.

Among the law's many provisions is one that allows FDA to temporarily authorize a medical product ("Emergency Use Authorization" or EUA) if it determines that an emergency is likely to occur—a "threat justifying emergency authorized use," to quote the legislation. That is a big change from prior legislation, which required a finding that such an emergency already existed in the US, and left little time for proactive efforts.

The law also allows FDA to authorize those products without first ensuring that they meet current good manufacturing practice (CGMP) regulations, which makes it easier to bring products to market without the usual regulatory burdens.

Between the law's passage in March 2013 and August 2014, FDA authorized just a small handful of medical products using emergency provisions, and all for diagnostic tests intended to allow health officials to diagnose emerging diseases like the H7N9 influenza virus and the Middle East Coronavirus (MERS CoV).

Ebola Outbreak Leads to Quick Authorizations

In the last few months, however, FDA has used its EUA authority to approve six diagnostic products, all intended for use in the fight against an alarming outbreak of the Ebola virus in West Africa.

On 5 August 2014, the US Department of Health and Human Services (DHHS) announced that it had determined that "the Ebola virus presents a material threat against the US population sufficient to affect national security," thereby allowing FDA to authorize the use of a diagnostic device for Ebola Zaire, the  Department of Defense's EZ1 Real-Time RT-PCR Assay ("TaqMan").

Following that notice, FDA quickly announced the authorization of an Ebola assay manufactured by the US Department of Defense called the EZ1 Real-time RT-PCR Assay.

New Authorization

Now FDA has announced the emergency authorization of a sixth device: the RealStar Ebolavirus RT-PCR Kit 1.0. The product, manufactured by altona Diagnostic GmbH of Hamburg, Germany, works by analyzing in vitro samples of plasma from persons thought to be infected with the Ebola virus.

Unlike some tests, the RealStar device differentiates itself by being able to detect all Ebola virus species, including Ebola Zaire—the virus now at the heart of the West African outbreak.

For a listing of other devices authorized by FDA for Ebola under emergency conditions, please see the following table:

Diagnostic TestDateLetter of AuthorizationFact Sheet for Healthcare ProvidersFact Sheet for PatientsLabeling
RealStar Ebolavirus RT-PCR Kit 1.011/10/14[Authorization][Healthcare][Patients][Labeling]
BioFire Defense LLC FilmArray Biothreat-E Test10/25/14[Authorization][Healthcare][Patients][Labeling]
BioFire Defense LLC FilmArray NGDS BT-E Assay10/25/14[Authorization][Healthcare][Patients][Labeling]
DoD EZ1 Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus NP Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]
CDC Ebola Virus VP40 Real-time RT-PCR Assay10/10/14[Authorization][Healthcare][Patients][Labeling]


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