FDA authorizes marketing of first SARS-CoV-2 diagnostic test using De Novo premarket review pathway
Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of COVID-19 and other respiratory tract infections.
The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA's response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.