April 3 Update – FAQs on Diagnostic Testing for SARS-CoV-2

April 3 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 has recently: Updated the answer to the following frequently asked question: When FDA authorizes under an EUA a SARS-CoV-2 test for use at the point of care, does that mean it is CLIA waived? Added the following frequently asked question and answer: When tests are offered prior to or without an EUA under the FDA’s Policy for Diagnostic Tests for Coronavirus Diseease-2019, what is their CLIA catergorization?

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