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

Thank you for your interest in development of diagnostics for SARS-CoV-2.  The FDA has updated the frequently asked questions on diagnostic testing for SARS-CoV-2 following yesterday’s update to the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff. What laboratories are offering testing under the Policy for Diagnostic Tests for Coronavirus Disease-2019? I am developing a COVID-19 assay that is a modification of a previously EUA authorized COVID-19 assay. Do I need to start from scratch with my validation or can I validate my test with a bridging study? I am developing a SARS-CoV-2 test kit for distribution to clinical laboratories. Can I follow the policy outlined in the Policy for Diagnostic Tests for Coronavirus Disease-2019?

See Updates to FAQs

Questions? Email CDRH-EUA-Templates@fda.hhs.gov