by Abby Higbee | Apr 5, 2021
On March 17th, 2021, the U.S. Food and Drug Administration (FDA) granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) using the De Novo premarket review pathway. The BioFire RP 2.1 is a diagnostic test for the simultaneous qualitative detection...
by Abby Higbee | Feb 2, 2021
In response to the Covid-19 Public Health Emergency, the U.S. Food and Drug Administration (FDA) permanently exempted seven Class I device types from 510(k) premarket notification requirements. FDA also proposed similar exemptions for 83 Class II devices and one...