FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.
Guidelines from health authorities are changing by the hour. It’s very difficult to keep track. What was true yesterday has been modified today and probably will be tomorrow. We have been in communication with the FDA, and even they are telling us to keep an eye on their website. On Saturday one FDA agent told us this :
”This is a very fluid situation and the guidance can change at any time.”
It is the wild wild west! So let’s try to make it easier to understand.
As an Initial Importer our focus is on 2 major topics. First is to make sure we understand where the FDA stands on registration, listing and premarket numbers especially in the context of Emergency Use Authorization (EUA). The second is in regard to importation itself; what information needs to be submitted to the FDA and the US Customs and Border Protection (CBP).