Emergency Preparedness and Response

MCMi News and Events

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News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners. This page is updated frequently.

  • December 23, 2014: FDA issued an EUA to authorize use of the LightMix® Ebola Zaire rRT-PCR Test for the presumptive detection of the Ebola Zaire virus in a preparation of whole blood from individuals with signs and symptoms of Ebola disease. The test runs only on specified instruments used by CLIA high complexity laboratories or similarly qualified non-U.S. laboratories. more

  • November 26, 2014: In response to altona Diagnostics GmbH’s request to amend this EUA, on November 26, 2014 FDA reissued (PDF, 263 KB) the November 10, 2014 EUA in its entirety with the altona Diagnostics GmbH-requested amendments incorporated. more

  • November 10, 2014(see note above about update on November 26, 2014) FDA authorized emergency use of the RealStar® Ebolavirus RT-PCR Kit 1.0 to detect Ebola viruses. This EUA provides another commercial Ebola diagnostic (in addition to the October 25, 2014 EUA for the BioFire Defense FilmArray Biothreat-E test). Note: Documents issued on November 10, 2014 are now archived. more

  • October 25, 2014: FDA authorized emergency use of two BioFire Defense diagnostic tests to detect the Ebola Zaire virus in individuals with signs and symptoms of Ebola virus infection, or who are at risk for exposure, or may have been exposed (in conjunction with epidemiological risk factors). The EUA for the FilmArray Biothreat-E test enables hospitals with laboratories that fit these characteristics to conduct a PCR test for Ebola in-house, without having to send the sample to an outside lab.  more

  • October 10, 2014: FDA authorized emergency use of two Centers for Disease Control and Prevention (CDC) diagnostic tests to detect the Ebola Zaire virus in individuals in affected areas with signs and symptoms of Ebola virus infection and/or epidemiological risk factors. Use of these tests is limited to qualified laboratories designated by the CDC. more

  • October 10, 2014: Upon request from the U.S. Department of Defense (DoD), FDA has reissued the August 5, 2014 Emergency Use Authorization (EUA) for use of a DoD diagnostic test to detect the Ebola Zaire virus. The reissued EUA replaces the August 5, 2014 EUA. The EUA has been amended to expand the types of specimens that can be tested to include whole blood and plasma, in addition to blood or plasma that has been treated to make the sample non- infectious. more

  • August 5, 2014: (see note above about update on October 10, 2014) Emergency Use Authorization for DoD EZ1 Real-time RT-PCR Assay for the presumptive detection of Ebola Zaire virus - FDA has authorized the use of an in vitro diagnostic test developed by the U.S. Department of Defense (DoD) to detect the Ebola Zaire virus. The agency has authorized its use in laboratories designated by DoD to help facilitate effective response to the ongoing Ebola outbreak in West Africa. (Related: August 12, 2014 Federal Register notice - HHS Declaration Regarding Emergency Use of In Vitro Diagnostics for Detection of Ebola; September 17, 2014 Federal Register notice - Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Zaire Virus) 

  • June  10, 2014: Emergency Use Authorization (Potential Emergency) for CDC IVD for MERS-CoV - In response to CDC’s request to amend this EUA, on June 10, 2014 FDA reissued the June 5, 2013 EUA in its entirety with the CDC-requested amendments incorporated.  more

  • April 25, 2014: Emergency Use Authorization (Potential Emergency) for Arbor Vita Corporation IVD for H7N9 Influenza

  • February 14, 2014: Emergency Use Authorization (Potential Emergency) for Quidel IVD for H7N9 Influenza (Federal Register notice)

  • January 2, 2014: FDA issued a PAHPRA question and answer document (PDF, 762 KB) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies

  • View more information and all current EUAs on our Emergency Use Authorization page, or view the EUA archive for EUAs that are no longer in effect
     

 

Page Last Updated: 01/30/2015
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