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. Don't miss important news: Subscribe to our email updates.

Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer - also see Zika Virus Diagnostic Development and Zika Emergency Use Authorization information
  • May 23, 2017: EUA amendment - In response to CDC’s request, FDA issued an EUA amendment (PDF, 28 KB) to (1) authorize additional strengths (i.e., 0.5 mg and 1 mg) of the authorized Rafa Atropine Auto-Injector under the April 11, 2017, EUA and (2) update the authorized EUA Fact Sheets for the authorized Rafa Atropine Auto-Injector to include information about the 0.5 mg and 1 mg strengths. The additional strengths are for pediatric patients weighing 15-40 pounds (0.5 mg) and 41-90 pounds (1.0 mg). The 2 mg strength remains authorized under the EUA for adults and children weighing over 90 pounds. Additional information, including fact sheets
  • May 19, 2017: EUA amendment - In response to Luminex’s request, FDA concurred (PDF, 126 KB) with the modifications to the authorized Instructions for Use (PDF, 642 KB) labeling and Fact Sheets for the xMAP® MultiFLEX™ Zika RNA Assay to include some minor updates and clarifications requested by FDA. Also see Zika Emergency Use Authorization information
  • May 10, 2017: The HHS Secretary issued a PREP Act Declaration under the Public Readiness and Emergency Preparedness Act to provide liability protections related to medical countermeasures against nerve agents and certain insecticides (organophosphorus and/or carbamate). The declaration was published in the Federal Register on May 10, 2017, with an effective date of April 11, 2017.

  • May 3, 2017: EUA amendment - In response to CDC's request, FDA concurred (PDF, 110 KB) with the modifications to the authorized Instructions for Use (PDF, 4.7 MB) labeling for the CDC Zika MAC-ELISA to (1) add the DynexTechnologies, Inc.’s Agility® and DSX® systems as acceptable automated instruments for use with the Zika MAC-ELISA, (2) add language recommending an additional negative human serum control be run once daily, (3) include a limitation concerning the use of the Hennessey detecting antibody conjugate 6B6C-1 in conjunction with the Vero E6 antigen when testing infant serum, and (4) update contact information. FDA also concurred with minor updates to the authorized Zika MAC-ELISA Fact Sheet for Healthcare Providers (PDF, 78 KB). Also see Zika Emergency Use Authorization information

  • April 12, 2017: EUA amendment - In response to Hologic, Inc.’s request, FDA concurred (PDF, 124 KB) with the modifications to the authorized Instructions for Use (PDF, 372 KB) labeling for the Aptima® Zika Virus assay to (1) extend the stability of processed urine specimens, (2) clarify storage and stability of serum and plasma specimens, and (3) improve the overall clarity and accuracy of the document. FDA also concurred with minor updates to the authorized fact sheets that were requested by FDA. Also see Zika Emergency Use Authorization information

  • April 11, 2017: FDA has issued (PDF, 514 KB) an EUA to permit the emergency use of the 2 mg Atropine Auto-Injector manufactured by Rafa Laboratories, Ltd. The 2 mg Rafa Atropine Auto-Injector is authorized for the initial treatment of certain specific symptoms of known or suspected poisoning in individuals exposed to nerve agents or certain insecticides (organophosphorus and/or carbamate). More information, including fact sheets

  • April 6, 2017: EUA amendment - In response to CDC's request, FDA concurred (PDF, 126 KB) with modifications to the authorized Instructions for Use (PDF, 1.3 MB) labeling for the CDC Trioplex Real-time RT-PCR Assay (Trioplex rRT-PCR) to (1) add the QuantStudio Dx Real-Time PCR instrument for use with the Trioplex rRT-PCR, (2) correct some typographical errors, and (3) make some revisions to improve clarity. Also see Zika Emergency Use Authorization information

  • April 5, 2017: FDA issued (PDF, 362 KB) an EUA for emergency use of DiaSorin Incorporated’s LIAISON® XL Zika Capture IgM Assay for the presumptive qualitative detection of Zika virus IgM antibodies in human sera collected from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria. This is the second commercial serological assay for Zika available under EUA, and the first available for use by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate complexity tests. Also see Zika Emergency Use Authorization information

  • January 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)
  • December 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
     

 

 

Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases.

Page Last Updated: 05/26/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English