In response to the covid-19 pandemic, the FDA updated the Molecular Diagnostic templates. The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and submission of requests for emergency use authorizations (EUAs). The updates are regarding diagnostic tests for use with sample pooling, at the point of care, and in the detection and differentiation of SARS-CoV-2 and other respiratory pathogens such as viruses that cause influenza. To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests. For more information, visit FDA.
July 1, 2020
January 21, 2014