Emergency Use Authorization (EUA)

Owing to the Covid-19 pandemic there has been a surge in demand for Medical devices (Diagnostic Devices, Blood Purification Devices, Ventilators, Lung therapy Systems) and Infectious disease test kits. Considering this, the FDA has given the Emergency Use Authorization (EUA) to over 120 Companies which either allow an unapproved medical product or the unapproved use of an approved medical product to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions as Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

However, as and when the need goes away, the FDA withdraws the EUA. This creates a need for all the OEMs who have put their products in the market with EUA, to get their products approved through the regular approval route to ensure product continuity. LTTS’ FDA EUA to 510K Transition Service is created to support the OEM’s through the transition.