FDA authorizes first COVID test via traditional review pathway

Regulatory NewsRegulatory News | 17 March 2021 |  By 

The US Food and Drug Administration (FDA) on Wednesday authorized the first diagnostic for COVID-19 using a traditional review process, paving the way for more tests to gain clearance through the agency’s 510(k) pathway.
After authorizing hundreds of SARS-CoV-2 diagnostics under emergency use authorizations (EUAs), FDA has authorized the BioFire Respiratory Panel 2.1 (RP2.1) for the simultaneous 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. FDA reviewed the test under its de novo pathway, which allows the agency to review new types of low- to moderate-risk devices and assign them a risk classification. In this case, FDA has classified the BioFire test as a Class II device subject to special controls.
Prior to the de novo authorization, the BioFire test had been in use under an EUA since May. Now that it has been authorized via a traditional pathway, FDA has revoked the EUA and clarified that the granting of the de novo authorization and revocation of the EUA “do not impact the availability of other tests under EUA.”
FDA says it granted the de novo request “based on additional data showing validation beyond what is needed for emergency use authorization,” including data from a clinical study of more than 500 test samples and a variety of analytical studies.
With the de novo authorization, FDA has also created a new regulatory classification and established special controls for labeling and performance testing for subsequent devices of the same type and intended use that will allow subsequent devices to be cleared through the agency’s 510(k) pathway.
“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,” said Acting FDA Commissioner Janet Woodcock.
Because EUAs are intended to be temporary authorizations during a public health emergency, medical device makers will eventually need to transition their product to traditional authorizations to continue to market them after the emergency phase of the pandemic expires. FDA’s Center for Devices and Radiological Health (CDRH) has said it plans to issue draft guidance outlining a transition plan for EUA devices and those distributed under enforcement policies during the pandemic. (RELATED: CDRH FY 2021 guidance slate includes post-EUA transition plan, Regulatory Focus 19 October 2020).


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy