This exact topic was discussed during the May 13th town hall Q&A. FDA stated that they are exercising enforcement discretion with respect to manufacturers being registered and listing the device. However, if the manufacturer is foreign and using a domestic importer, the importer will need to be registered.
The disclaimer I will put here is that the folks giving this answer were not 100% positive this was correct with respect to importers but believed this to be the case. They suggested to email them at
CDRH-EUA-Templates@fda.hhs.gov to get the true answer once they can confer with others internally. Perhaps FDA will add this to their
FAQ page once they get a clear answer. Otherwise, you can look for this discussion in the May 13 town hall transcript they will eventually post to their
town hall page.
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Christie Hughes MT(ASCP), MPH
Consultant
Austin, TX
United States
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Original Message:
Sent: 12-May-2020 06:12
From: Anonymous Member
Subject: Establishment registration & Listing post EUA approval
This message was posted by a user wishing to remain anonymous
Hello,
My question is regarding Establishment registration & Listing post EUA approval.
Is it required to have establishment registration and listing done to sell under a EUA.
The FDA EUA template says ""FDA recommends that you consider registration and listing your EUA product once you have been issued an EUA."
Is it a must? Does anyone has a practical experience with FDA expectations on this?
Any insight is highly appreciated!