April 11 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 Aprill 11, 2020, the FDA updated the frequently asked questions to include the following new information: What is the difference between the types of tests available for SARS-CoV-2? Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection? If antibody tests are not used for diagnosis or exclusion of SARS-CoV-2 infection, what is their purpose? Can I offer my SARS-CoV-2 antibody test kit in the US 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 testing while I prepare and submit an EUA? I am developing a SARS-CoV-2 antibody test kit and want to pursue an EUA. Is there an EUA template for COVID-19 antibody tests? What are the current recommendations regarding minimum testing for demonstrating performance of a new SARS-CoV-2 antibody assay?

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