I think you are right....... How can the FDA "require" a reporting mechanism for the approval of a device that seeks to test the positivity of the virus or not. Does an at-home pregnancy test require the results of the test be sent to "someone" or a board of health somewhere?
Sounds unconstitutional if the FDA is holding back on CoviStix EUA approval because of a "reporting requirement", get it approved without that requirement and sell it to the rest of the world who will gladly snap it up. Can't believe the lengths to which the govt will go to CONTROL the narrative and this China virus.....