• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Emergency Preparedness and Response

  • Print
  • Share
  • E-mail

MCMi News and Events

Medical countermeasure photo montage with scientist in lab, flu virus particle (magnified), gloved hands administering vaccine, pill bottles

News from the FDA Office of Counterterrorism and Emerging Threats (OCET), Medical Countermeasures Initiative (MCMi), and federal and industry partners

 

  • August 5, 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.  The amendments authorize the expanded use of the CDC assay to include testing persons who may not be exhibiting signs and symptoms associated with MERS-CoV infection, but who meet certain epidemiological risk factors. The EUA amendments also include a new fact sheet for contacts of MERS cases and revisions/updates to the instructions for use and fact sheets for patients and health care professionals. This device will be distributed by CDC to qualified laboratories.

  • 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

  • June 5, 2013: FDA issues Emergency Use Authorization (EUA) for CDC Novel Coronavirus 2012 Real-time RT-PCR Assay (replaced - see June 10, 2014 entry above)

  • April 22, 2013: H7N9 Influenza Emergency Use Authorization (Potential Emergency) FDA issued an Emergency Use Authorization (EUA) for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay. This test is for the presumptive detection of novel influenza A (H7N9) virus in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays in patients with signs and symptoms of respiratory infection. CDC will distribute this device to public health- and other qualified laboratories.

  • View more information on our Emergency Use Authorizations page
     

Follow Us On Twitter Follow @FDA_MCMi on Twitter
 
Sign up for MCMi email updates Subscribe to MCMi email updates disclaimer icon