On March 16, 2020, FDA issued its Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (the “Guidance”). The purpose of the Guidance is to expedite the availability of novel coronavirus (SARS-CoV-2) diagnostic tests in view of the current public health emergency. The Guidance contains policies regarding (i) laboratories’ development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers’ development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.
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