If you have some free time, and want to get an insight into how the FDA operate, I recommend you watch "The Bleeding Edge" on Netflix.
Its a Netflix Original documentary film that investigates the $400 billion medical device industry and has actual footage of an FDA 'medical device application meetings'. (I found how they operated to be quite confronting).
It also makes you realize what Resapp is up against when it comes to dealing with the good old US of A!
GLTA
FDA Approvals Resapp + Sleep Check, page-3
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #