August 14 Update – FAQs on Testing for SARS-CoV-2

August 14 Update: New Information on Testing for SARS-CoV-2

Thank you for your interest in the development of diagnostics for SARS-CoV-2.   The FDA recently: UPDATED the answer to the following question: I am a commercial test kit manufacturer or clinical laboratory offering a SARS-CoV-2 diagnostic test.  Can I offer it for screening of asymptomatic individuals for COVID-19? ADDED the following question and answer: Does FDA have recommendations for healthcare providers using SARS-CoV-2 diagnostic tests for screening asymptomatic individuals for COVID-19?

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