May 6 Update – FAQs on Testing for SARS-CoV-2

May 6 Update: Updated Information on Testing for SARS-CoV-2

Thank you for your interest in the development of test for SARS-CoV-2.  On May 6, 2020, the FDA recently: Updated the answer to the following questions: Can I offer my test for home use, including self-collection of a specimen, testing, and interpreting results, under the Policy for Coronavirus Disease-2019 Tests? Can I offer my test for self-collection of a specimen at home and shipping to a laboratory for testing under the policies outlined in the Policy for Coronavirus Disease-2019 Tests? I am having trouble obtaining viral transport media/universal transport media (VTM/UTM) and a flocked nasopharyngeal swab to collect and transport patient samples. Are there alternatives that I can use?

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