FAQs on Testing for SARS-CoV-2 | FDA

FAQs on Testing for SARS-CoV-2 | FDA

May 9 Update: New Information on Testing for SARS-CoV-2

Thank you for your interest in the development and performance of tests for SARS-CoV-2.  The FDA has recently: Updated the answer to the 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 questions and answers: Do all COVID-19 tests require a prescription?  Do they need to be ordered by a physician? I operate a pharmacy and would like to offer COVID-19 testing.  What tests are available for use?  Where do I get test kits? I am offering COVID-19 testing with an EUA-authorized test kit.  Should I notify FDA?   I am offering COVID-19 testing with a test kit listed on the notification lists for tests being offered under the policy in Section IV.C or IV.D in the Policy for Coronavirus Disease-2019 Tests.  Should I notify FDA?

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