mdi Consultants
01
Sep
FDA Update: Recent De Novo Approval for SARS-CoV-2 Multi-Target Respiratory Specimen NAAT
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