Implementation of Emergency Use Authorization (EUA) Process and Speedy Access of required tests by EUA
Committee:IVD (In Vitro Diagnostics)
In the event of COVID-19 pandemic, needs of transparent process like EUA were recognized. With such process, clinical tests with certain level of quality and performance can be speedily provided to the public.
- Requests for implementing EUA and speedy market delivery of all tests required in the event of emerging infectious disease (including IVD, LDT, and research reagents, not limited to medical applications)