The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization. This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more information about the traditional premarket review and authorization process.
Background
Initially, COVID-19 tests were only available under emergency use authorization (EUA)External Link Disclaimer. Since the Secretary’s 564 declaration related to in vitro diagnostic tests for COVID-19, on February 4, 2020, the FDA has granted EUAs for many COVID-19 tests. Tests with an active EUA can continue to be used as long as they are available and not expired. The FDA has also issued a guidance document with a Transition Plan for Medical Devices Issued EUAs Related to COVID-19 and encourages EUA holders to pursue traditional marketing authorization. Visit the COVID-19 Test EUA page for more information about these EUAs.
The EUA process is different than traditional clearance or approval of these products. The FDA may issue an EUA when the FDA has determined, based on the totality of scientific evidence available to the FDA, that it is reasonable to believe that the product may be effective for the intended use relevant to the emergency and that the known and potential benefits outweigh the known and potential risks of the product. This is different than the traditional device premarket review pathways, where the FDA considers whether there is a reasonable assurance of safety and effectiveness when the device is used as intended.
COVID-19 Tests Granted Traditional Marketing Authorization
CDRH remains committed to expanding access to safe and effective tests through the FDA’s traditional premarket review pathway. The tables below list COVID-19 tests that have been granted marketing authorization by the FDA.
COVID-19 Tests Granted Traditional Marketing Authorization by the FDA | FDA
COVID-19 Tests Granted Marketing Authorization
COVID-19 tests that are authorized for marketing under FDA traditional premarket authorities.
www.fda.gov
