April 17 Update: New Information on Diagnostic Testing for SARS-CoV-2

Thank you for your interest in the development of diagnostics for SARS-CoV-2.  On April 17, 2020, the FDA updated the following frequently asked questions to include new information: What laboratories are offering testing under the policy outlined in Section IV.A of the Policy for Diagnostic Tests for Coronavirus Disease-2019? What commercial manufacturers are distributing test kits under the policy outlined in Section IV.C of the Policy for Diagnostic Tests for Coronavirus Disease-2019? What serology tests are being offered under the policy outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019? Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection? If antibody tests are not used for diagnosis or exclusion of COVID-19 infection, what is their purpose? Can I offer my SARS-CoV-2 antibody test kit in the United States without an EUA? I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA? I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. If my validation is complete, can I notify FDA and begin offering my test for patient testing while I prepare and submit an EUA? I am offering a serology test for SARS-CoV-2 under the policy outlined in Section IV.D of the Policy for Diagnostic Tests for Coronavirus Disease-2019. Is there an opportunity to have my serology test independently validated by the FDA? What happens if I do not have the extraction platform referenced in the authorization of CDC's EUA-authorized test?

See Update to FAQs Questions? Email CDRH-EUA-Templates@fda.hhs.gov