On March 17th, 2021, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) using the De Novo premarket review pathway. The BioFire RP 2.1 is a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from individuals suspected of COVID-19 and other respiratory tract infections. The BioFire RP2.1 was originally authorized for emergency use in May 2020 but will now be the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.¹
This authorization marks an important step, not only in the fight against COVID-19, but also creating a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway. Devices can now obtain clearance by demonstrating substantial equivalence to a predicate device.
Emergency Use Authorizations (EUA) are designed to allow the use of unapproved medical products or unapproved uses of approved medical products during public health emergencies, but once the EUA declaration is terminated, any EUA(s) issued based on that declaration will no longer remain in effect. Manufacturers of these medical products should pursue premarket submissions through the appropriate regulatory pathway (e.g., 510(k), De Novo request, PMA) during the emergency so that devices can remain on the market after the emergency.²
Pearl Pathways provides comprehensive quality and regulatory support in the preparation of both EUA requests and premarket submissions to ensure our clients’ devices can be brought to and remain on the market during and after the public health emergency is over. If you require support for your regulatory product application and submission, contact us today.