May 5 Update – FAQs on Diagnostic Testing for SARS-CoV-2

May 5 Update: Information on Diagnostic Testing for SARS-CoV-2

The FDA recently updated the frequently asked questions on diagnostic testing for SARS-CoV-2 based on the policies outlined in the Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: Policy for Coronavirus Disease-2019 Tests during the Public Health Emergency (Revised), originally introduced as Immediately in Effect Guidance for Clinical Laboratories and Food and Drug Administration Staff: Policy for Diagnostic Tests in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency on February 29, 2020 and updated on March 16, 2020 and again on May 4, 2020.

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