M
MIREGMGR
For a while now, FDA has been prioritizing attention toward both apps, and technology changes related to data handling and transmission.
My guess is that if there is an uncertainty as to the applicability of the 510(k) guidance, FDA's stance will be that a new review is required; or if you don't get one and go to market anyway, and then your device comes to FDA's attention, that it's illegally marketed.
My guess is that if there is an uncertainty as to the applicability of the 510(k) guidance, FDA's stance will be that a new review is required; or if you don't get one and go to market anyway, and then your device comes to FDA's attention, that it's illegally marketed.