This message was posted by a user wishing to remain anonymous
Our company (molecular diagnostic test developer) has an EUA for a molecular assay testing for COVID-19 and would like to amend it for home collection.
This amendment would be for one testing lab only, let's call it Lab X, which whom we work closely.
We plan on having the kits be produced by a contractor manufacturer.
Is there a reason for which the contracted manufacturer
cannot be Lab X, to whom we will be providing these home collection kits ultimately?
Thank you very much!