Emergency Preparedness and Response

MCMi News and Events

collage of images illustrating medical countermeasures
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.

  • April 22, 2015: The HHS Secretary issued a PREP Act declaration, effective February 27, 2015, to provide liability protection for activities related to Ebola virus disease therapeutics consistent with the terms of the declaration. (Federal Register notice - about the PREP Act)

  • March 23, 2015: FDA issued an EUA to authorize emergency use of the Xpert® Ebola Assay for the presumptive detection of Ebola Zaire virus.The test should be performed in CLIA moderate and high complexity laboratories, or similarly qualified non-U.S. laboratories, by personnel who have received specific training on the use of the Xpert® Ebola Assay on GeneXpert Instrument Systems. more

  • March 16, 2015: At the request of the manufacturer, FDA reissued the ReEBOV™ Antigen Rapid Test Emergency Use Authorization, first issued February 24, 2015, to allow distribution by certain authorized distributors. The Instructions for Use (PDF, 474 KB) have also been updated to incorporate these amendments. more

  • March 2, 2015: In response to CDC’s request, FDA reissued the two October 10, 2014 CDC EUAs in their entirety. The amendments authorize use of the CDC Ebola Virus NP Real-time RT-PCR Assay and the CDC Ebola Virus VP40 Real-time RT-PCR Assay with the BioRad CFX96 Touch Real-Time PCR instrument, in addition to the Applied Biosystems (ABI) 7500 Fast Dx Real-Time PCR instrument.  The Instructions for Use and Fact Sheets for Health Care Providers have also been updated to incorporate these amendments (updated attachments).  The amendments also allow the future use of “other authorized instruments,” of “other extraction methods” and of “other authorized specimen types” when requested by CDC and concurred with by FDA. more

  • March 2, 2015: In response to BioFire Defense, LLC’s request, FDA reissued (PDF, 326 KB) the October 25, 2014  FilmArray NGDS BT-E Assay EUA in its entirety. The amendments authorize use of plasma and serum specimens with the FilmArray NGDS BT-E Assay in addition to whole blood. The Instructions for Use (PDF, 740 KB) and Fact Sheet for Healthcare Providers (PDF, 40 KB) have also been updated to incorporate this amendment.  The amendments also allow the future use of “other specimen types” when requested by BioFire Defense and concurred with by FDA. more

  • February 27, 2015: Determination and Declaration Regarding Emergency Use of New In Vitro Diagnostics for Detection of Enterovirus D68 - On February 6, 2015, the HHS Secretary determined that there is 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 that involves enterovirus D68 (EV-D68). On the basis of this determination, she also declared that circumstances exist justifying the authorization of emergency use of new in vitro diagnostics for detection of EV-D68.

  • February 24, 2015: (see note above about update on March 16, 2015) FDA granted an Emergency Use Authorization (EUA) for Corgenix’s ReEBOVTM Antigen Rapid Test. This is the first rapid assay to detect Zaire Ebola virus authorized for use during the current Ebola epidemic in West Africa. The authorized ReEBOV™ Antigen Rapid Test is intended for circumstances when use of a rapid Ebola virus test is determined to be more appropriate than use of an authorized Ebola virus nucleic acid test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus. Note: Documents issued on February 24, 2015 are now archived. more

  • 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: (see note above about update on March 2, 2015) 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. Note: Documents issued on October 25, 2014 associated with the NGDS BT-E Assay are now archived. more

  • October 10, 2014: (see note above about update on March 2, 2015) 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. Note: Documents issued on October 10, 2014 are now archived. 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: 04/29/2015
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