FAQs on Testing for SARS-CoV-2 | FDA

FAQs on Testing for SARS-CoV-2 | FDA

June 19 Update: New Information on Diagnostic Testing for SARS-CoV-2

Thank you for your interest in the development of diagnostics for SARS-CoV-2.  The FDA recently: Updated the answer to the question: What commercial manufacturers of serological tests had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list?

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