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.

  • May 12, 2015: FDA issued an EUA for the CDC Enterovirus D68 2014 Real-time RT-PCR Assay (EV-D68 2014 rRT-PCR) for the in vitro qualitative detection of RNA from the Enterovirus D68 (EV-D68) strains detected in North America in 2014. This device will be distributed by CDC to qualified laboratories designated by CDC. more

  • 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.

  • 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: 05/22/2015
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