March 25 COVID Quick Takes: Biofire gets FDA’s first premarket authorization for COVID-19 test; plus CureVac, CanSino, Regeneron and AZ

FDA has granted its first premarket authorization for a COVID-19 test using its De Novo premarket review pathway, instead of its emergency use authorization (EUA) pathway. The BioFire Respiratory Panel 2.1 from Biofire Diagnostics LLC, which received EUA in December, is the first COVID-19 diagnostic that can be marketed beyond the public health emergency. The EUA was revoked when the De Novo pathway authorization was granted.

FDA also established special controls that define requirements related to labeling and performance testing, which creates a new regulatory classification that enables subsequent devices of the same type with the same intended use to go through FDA’s 510(k) pathway...