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Home 5 Articles 5 Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test

Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test

by | Feb 22, 2022 | Articles, COVID-19, News, Open Content

On Jan. 27, BioFire Defense’s COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than 300 COVID-19 diagnostic tests to reach the US market during the public health emergency (PHE) have received emergency use authorization (EUA) under Section 564 of the Food, Drug & Cosmetics Act. While it provides for accelerated access to the US market, EUA authorization remains valid for as long as the PHE that prompted it remains in effect. So, if the coronavirus is still around when the U.S. Department of Health & Human Services declares an end to the current PHE, there may not be enough fully authorized tests that labs can use to diagnose COVID-19. Accordingly, the FDA recently released draft guidance to prevent disruption of test supplies. The guidance provides for grandfathering distribution and use of EUA COVID-19 tests for two years after the PHE ends. It also sets out a pathway test makers can use to transition their products from EUA status to full regulatory approval. The BioFire Defense assay is the […]

Pcr well plate on 96 well microplate with biological samples.

On Jan. 27, BioFire Defense’s COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal.

In fact, almost all of the more than 300 COVID-19 diagnostic tests to reach the US market during the public health emergency (PHE) have received emergency use authorization (EUA) under Section 564 of the Food, Drug & Cosmetics Act. While it provides for accelerated access to the US market, EUA authorization remains valid for as long as the PHE that prompted it remains in effect. So, if the coronavirus is still around when the U.S. Department of Health & Human Services declares an end to the current PHE, there may not be enough fully authorized tests that labs can use to diagnose COVID-19.

Accordingly, the FDA recently released draft guidance to prevent disruption of test supplies. The guidance provides for grandfathering distribution and use of EUA COVID-19 tests for two years after the PHE ends. It also sets out a pathway test makers can use to transition their products from EUA status to full regulatory approval.

The BioFire Defense assay is the first full approval for a COVID-19 test announced since the guidance came out. On March 17, 2021, the agency granted the first De Novo approval for a COVID-19 test to another BioFire product, the BioFire Respiratory Panel 2.1 (RP2.1).