PolicyApril 21, 2020
FDA Authorizes First COVID-19 Test for Home Collection
FDA COVID-19 EUA
- On April 20, 2020, the US FDA authorized the first COVID-19 test for home collection of specimens. Importantly, the Emergency Use Authorization (EUA) is specifically for the home specimen collection method for the LabCorp COVID-19 RT-PCR Test. The specimen must still be sent to a laboratory for processing and test reporting.
- FDA has advised that any COVID-19 test intended for use at-home, including the use of a self-collection device or method, requires an authorized EUA. This guidance applies to any testing conducted via telehealth/telemedicine.
- COVID-19 tests that have been an authorized by FDA, including EUA’s for home collection, can be found on the FDA Emergency Use Authorizations page.
- For additional information on COVID-19 testing and FDA EUA, please visit the FDA FAQ on Diagnostic Testing page.
FDA FAQs on Diagnostic Testing