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Regulatory Focus™ > News Articles > FDA Finalizes Emergency Approval of Device Intended to Detect Presence of Deadly Virus

FDA Finalizes Emergency Approval of Device Intended to Detect Presence of Deadly Virus

Posted 16 July 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has issued a formal notice in the Federal Register authorizing the Emergency Use Authorization (EUA) of a diagnostic test meant to test for the presence of the Middle East Respiratory Syndrome Coronavirus (MERS-CoV), an emerging and deadly virus that already has public health officials - including FDA - significantly alarmed.


FDA was recently given the authority to change the way it issued EUAs under the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), passed in March 2013. The law allows FDA to temporarily approve products based on a finding that an emergency is likely to occur. Prior to the passage of PAHPRA, it could only issue such a finding if an emergency (i.e. an epidemic or pandemic) was already in effect.

The agency has already used the new authority several times, including against an emerging strain of influenza virus (H7N9).


And as Regulatory Focus reported in June 2013, the agency recently approved the Center for Disease Control and Prevention's (CDC) Novel Coronavirus 2012 Real-time RT-PCR Assay, a real-time reverse transcriptase PCR for the in vitro qualitative detection of MERS-CoV viral RNA. As part of the approval, FDA said it would waive current good manufacturing practice (CGMP) requirements for the device under 21 CFR 820, as well as labeling requirements under 21 CR 809.10 and 809.30.

FDA's approval was based on a 5 June 2013 Federal Register announcement by the Department of Health and Human Services (DHHS) in which it declared that MERS-CoV exhibited 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, [DHHS Secretary Kathleen Sebelius] also declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of MERS-CoV pursuant to section 564 of the Federal Food, Drug and Cosmetic Act, subject to the terms of any authorization issued under that section."


The 17 July 2013 Federal Register notice serves to formalize FDA's reaction to that notice, per requirements under Section 564(h)(1) of the FD&C Act.

"Having concluded that the criteria for issuance of the Authorization under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of an in vitro diagnostic device for detection of MERS-CoV subject to the terms of the Authorization," it wrote.

More information can be found on FDA's EUA webpage here.

Federal Register Notice

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