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§ 263a, to perform high complexity tests, or by similarly qualified non-U.S. The assay is intended for use with specimens collected from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated), by laboratories in the United States (U.S.) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. On August 11, 2017, the FDA issued an Emergency Use Authorization (EUA) for emergency use of The Center for Infection and Immunity, Columbia University's ('Columbia University') CII-ArboViroPlex rRT-PCR assay for the qualitative detection and differentiation of RNA from Zika virus, dengue virus, chikungunya virus, and West Nile virus in serum, and for the qualitative detection of Zika virus RNA in urine (collected alongside a patient-matched serum specimen). For more information about EUAs in the context of the Zika virus response, please visit FDA's medical countermeasures website. In addition to sensitivity, the currently authorized tests offer unique characteristics with respect to sample throughput, testing environment, claimed sample types and performance, that are taken into account when considering whether to issue an EUA for an assay, summarized in Table 2. Depending on the sample type, the majority of the NAT assays have analytical sensitivities between 5 Units/mL (or better) summarized in Table 1, along with some other performance characteristics determined during the EUA evaluation. In the case of the molecular-based assays, IVD developers as part of their EUA conditions are required to test an FDA Reference Material Panel that includes two different Zika virus strains from the Asian lineage (S1 and S2), using an FDA protocol that included a sensitivity evaluation. Since February 26, 2016, when the Secretary of Health and Human Services (HHS) declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, FDA has issued an Emergency Use Authorization (EUA) for a number of molecular- and serological-based assays for Zika. Zika Virus Molecular Emergency Use Authorization (EUA) Assays – Performance Evaluation and Key Characteristics: § 360bbb-3(b)(1)), and on the basis of such determination, the Secretary of HHS then declared that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under 21 U.S.C. Pursuant to section 564(b)(1) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of Health and Human Services (HHS), Sylvia Burwell, 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 and that involves Zika virus. 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency).

2013 Coronavirus Emergency Use Authorization (Potential Emergency).2014 Ebola Virus Emergency Use Authorizations.Coronavirus (COVID-19) and Medical Devices.

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