Mind reading the FDA through a TOS nr is not likely to work or TOS wouldn't be in the position it is in.
The items formerly sterilized in cycle 3 are not able to work in cycle 1. They don't even make up 1% of the total load. These items you mention that won't be processed in TOS' 1 cycle system were never required to be sterilized anyway, so will be disinfected as per regulations.
TOS and 3M were trying to have regulations beefed up to force sterilization of GI equipment, but that iniitative will have to wait until dowwn the road, if and when they get the 3 cycles approval.
A deal with Getinge will change the game, however Rumble obviously wasn't expecting it last week after putting out the new application nr, or he would have waited for a combined nr. I still imagine he must think he is somewhat close, but being half pregnant isn't possible, so here we sit waiting for news to see if he can pull it off.