FDA Granted Marketing Authorization of First COVID-19 Diagnostic Test Using De Novo Review Pathway
On March 17, 2021, the U.S Food and Drug Administration permits marketing authorization of the BioFire Respiratory Panel 2.1 (RP 2.1). This diagnostic test was originally authorized under the Emergency Use Authorization pathway in May 2020 and now it was granted marketing authorization using the De Novo premarket review pathway. De Novo is a regulatory pathway for low-to moderate-risk devices of a new type.
The FDA sees the grant of this De Novo request as an important moment of the agency toward the COVID-19 pandemic because it is the first COVID-19 diagnostic test that will be permitted to be marketed beyond the public health emergency.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” said FDA Acting Commissioner Janet Woodcock, M.D. “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.”
The clearance of the De Novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens.
With granting of the De Novo for the BioFire Respiratory Panel 2.1, the agency revoked the EUA status for this device, as a part of the transition to De Novo clearance.
FDA noted that, along with this De Novo authorization, the agency is establishing special controls that define the requirements related to labeling and performance testing.
"When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type."
Additionally, this action also creates 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, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.", the FDA said.