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.

  • January 13, 2017: Guidance - Emergency Use Authorization of Medical Products and Related Authorities - This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents: Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009). (Federal Register notice)
  • January 12, 2017: EUA amendment - In response to CDC's request, FDA concurred (PDF, 132 KB) with the modifications to the authorized Instructions for Use labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) clarify the volume of lysis buffer preferred for use with the authorized easyMAG extraction instrument, (2) add a singleplex reaction option for the Trioplex rRT-PCR, and (3) clarify the expected positive control values/ranges in the Trioplex Positive Control package insert. Also see Zika Emergency Use Authorization information

  • January 7, 2017: EUA amendment - In response to Luminex Corporation's request, FDA concurred (PDF, 126 KB) with the modifications to the authorized xMAP® MultiFlex™ Zika RNA Assay Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients (PDF, 157 KB) and to include updated language to align with the latest CDC Zika Laboratory Guidance, implemented in November 2016. The Instructions for Use remains unchanged by this request. Also see Zika Emergency Use Authorization information

  • January 6, 2017: EUA amendment - In response to Abbott Molecular Inc.'s request, FDA concurred (PDF, 150 KB) with the modification to the authorized Abbott RealTime ZIKA assay Kit Fact Sheets to include EDTA whole blood as an authorized specimen type. FDA also concurred with related updates to the Instructions for Use (PDF, 1.2 MB) and Fact Sheets for healthcare providers (PDF, 203 KB) and patients (PDF, 216 KB).  Also see Zika Emergency Use Authorization information

  • December 19, 2016: EUA amendment - In response to Siemens Healthcare Diagnostics Inc.'s request, FDA concurred (PDF, 124 KB) with the modification to the authorized VERSANT Zika RNA 1.0 Assay (kPCR) Kit Fact Sheets to combine the Fact Sheet for Patients and the Fact Sheet for Pregnant Women into one Fact Sheet for Patients (PDF, 122 KB) and to include updated language to align with the latest CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, implemented in November 2016. Also see Zika Emergency Use Authorization information

  • December 12, 2016: The HHS Secretary has amended two Public Readiness and Emergency Preparedness (PREP) Act declarations, continuing PREP Act coverage for Ebola virus disease vaccines and therapeutics. This is the second amendment to the February 27, 2015, Declaration. Also see PREP Act FAQs.

  • FDA issued a PAHPRA question and answer document (PDF, 762 KB) in 2014 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
     

 

 

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Page Last Updated: 02/23/2017
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