The FDA announced that it granted marketing authorization to BioFire Diagnostics for its SARS-CoV-2 (COVID-19) test.
Although the test already had emergency use authorization (EUA), the new marketing authorization was granted through the De Novo premarket review pathway, marking the first SARS-CoV-2 diagnostic permitted to be marketed beyond the public health emergency, according to an FDA release.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” FDA Acting Commissioner Dr. Janet Woodcock said in the release. “We ensured there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities.
“While this is the first marketing authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways.”
De Novo authorization for the test was granted based on additional data showing validation beyond what is needed for EUA. The FDA said it reviewed data from a clinical study of more than 500 test samples that demonstrated a reasonable assurance that the BioFire RP2.1 diagnostic was safe and effective at identifying and differentiating various respiratory viral and bacterial pathogens.
In granting De Novo clearance for BioFire RP2.1, the FDA revoked the EUA, which was initially granted in May 2020. The revocation and new authorization do not impact the availability of other tests under EUA, the FDA noted.
The FDA is also establishing criteria called special controls to define the requirements related to labeling and performance testing, in which special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This also creates a new regulatory classification, meaning subsequent devices of the same type with the same intended use can go through the FDA’s 510(k) pathway.
“Safety, effectiveness and innovation remain important priorities for CDRH. Today’s action underscores the FDA’s ongoing commitment to expand access to testing while providing important safeguards through both our EUA authority and traditional review pathways,” added FDA Center for Devices & Radiological Health director Dr. Jeff Shuren.