WHY FDA TAKES SO LONG… MANY FACTORS…Reposting, as I posted in response, but not all will see it...
Why does it take so long for FDA EUA? There are many factors. Do your own due diligence ...
First...Go find when all these other antigen test companies (20) submitted their paperwork from the time they first got FDA EUA authorized. 20 companies with a total of 20 tests (1 each), many tests have been submitted multiple times for different use purposes - point of care, at home with healthcare proctor, at home with digital reporting app, etc... but they are all the same antigen tests just getting approve for different purposes. (Ie: total 34 submission).
Abbott has 1 test on this board, but about 6 different submissions for different purposes. Find out when they submitted their VERY FIRST test (for Point of Care) to the FDA and when it finally received EUA. Do the same for Quidel, Access Bio, etc. Check when their very first tests were authorized and when submitted. EUA dates are all on this link. Trace back to when they each sent their paperwork to FDA, some may have announced submitting, others may not have. That's where real investigative work begins... and trust me…it's time consuming.
You might find that for some, it was less than 30 days, where as with others, it was more than 30 days.... Also, the FDA may have given the 3rd Pfizer Booster Shot priority this week, or Pfizer's 5-11yrs old child vacinnes more priority. Or other Antigen, PCR and/or Antibody tests priorty that were in the que. Many factors can allow for speed or slowness in this Emergency Use Authorization process. Do your own due diligence. No one will do it for you.
The link below is to the 20 antigen tests with FDA EUA. Plus,it will take you to 2 other lists - PCR list with over 200 PCR (lab & high tech machine required/time consuming) FDA EUA tests and Antibody list with over 80+ antibody tests with FDA EUA. . All this began back in March 2020.
Lots of PCR and Antibody tests ... very very few rapid antigen tests. Its 1 antigen test to 10+ PCR and 4+ antibody tests. That too can tell the volume of different test that may be in the que. But all the same evaluation & authorization process.
Have a look... do your own due diligence ... ;).
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2 0