If AcuVid is Well Into the Queue.......an NR should not be that far down the road.
Two more rapid antigen tests were given FDA EUA approval on Friday. One was an add on for an existing FDA EUA. The other was new but is more complicated than AcuVid and requires a clinic to carry out the test. While I can't determine the number of tests currently in the pipeline, the relatively few tests that have been authorized suggests the list under review may very well be short ...particularly when considering the niche AcuVid could support.
It looks like the same Chief Scientist is responsible for the letter of authorization for all these tests. Also much of each of the authorization letters is identical so it appears preparing the authorization would be straightforward. As such when authorization is established the letter of authorization could be completed immediately.
Does the FDA, like HC, have a site that lists devices currently under review? I have not been able to find one.
Cheers!!!