FAQs on Testing for SARS-CoV-2 | FDA

FAQs on Testing for SARS-CoV-2 | FDA

May 20 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: Added the following frequently asked question and answer: 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? If I do not have assay positive control material, how can I obtain it?

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