Up until recently, the only way to market your SARS-CoV-2 tests was through an EUA application. EUA applications were implemented during the COVID crisis and were only a temporary and not a permanent way to market your device.
For the SARS-CoV-2, there was no Substantial Equivalency and so a 510(k) was not an available option for getting FDA clearance to market. The only way to get FDA approval for this test was via the De Novo process.
On March 17, 2021 a De Novo application from BioFire Diagnostics, LLC, was approved for a multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents. The product classification for this device is QOF and is class II. The technical method of the device is a nucleic acid amplification test (NAAT) that is PCR based using a nasopharyngeal swab specimen. You can find the de novo decision summary on the FDA’s website.
This application has just paved the way for other companies trying to have a more permanent way of marketing their tests through the 510(k) regulatory pathway. This is great news for other covid tests that were being marketed under the EUA. These companies can now use this De Novo application as their predicate device when applying for a traditional 510(k) application to market their SARS-CoV-2 devices.
We at mdi recommend that anyone looking to market their SARS-CoV-2 tests through the 510(k) regulatory pathway as a more permanent marketing solution. We also see that if there are 510(k)s being submitted for FDA review, the FDA will give preference over any EUA applications, since the FDA is not mandated to review EUA applications but they are obligated to review 510(k)s. Also remember, once the EUA has been revoked all tests must be cleared through the 510(k) process to continue to market in the United States.
mdi has extensive experience in 510(k) preparation and submissions with over 4000 cleared devices and IVDs. If you would like to discuss this 510(k) process and assistance with your 510(k) application, now including SARS-CoV-2 tests, please email mdi Consultants at firstname.lastname@example.org RE: SARS 510(k).