FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs 

This week FDA announced that it is going to require emergency use authorizations (EUA) for Lab Developed Tests (LDTs) intended for Covid diagnosis summarily reversing a decision last August that LDTs don’t need EUA. While this may seem like a major decision, it is not. The announcement is very specific to RT-PCR tests for Covid, … Read more