Earlier quoted context omitted.
> Alternative submission pathways: what do you mean by this precisely De novos, abbreviated 510(k)s, lesser used pathways. > Pre-cert: I think the premise is correct, in that the current quality system regulations aren’t well suited to modern SW development practice. But the devil will be in the details. Regardless it won’t affect us significantly because whatever gets released will have to have a phase-in for existi…
> De novos, abbreviated 510(k)s, lesser used pathways. De novo’s definitely, abbreviated 510(k)’s as well (that’s more of a requirements -> standard conformance challenge which a system like ours is particularly suited to demonstrate), but to your point they’re not that common. > In my eyes it's really a question of how long FDA will be expecting traditional submissions while they roll out a model geared more around…
Yeah fair enough; it's true that there has been a large regulatory shift with the appearance of general wellness and enforcement discretion and the resulting erosion of class 1 and somewhat of class 2.
> The near term challenge for digital health, until precert comes online, is that there are a limited number of software experts at FDA. To the Agency’s credit, they have recognized this and are trying to remedy it. But the big problem we see with software submissions is that things get overlooked, and in such a way that speaks to an overworked reviewers. This of course leads to delays, which is why it’s very important for software submissions to be buttoned up. This is one the things we’re tryijg to make happen with our QMS, which generates more reports that clearly map from requirement->code->test.
I totally agree with this. If you could create a software submission which efficiently communicated traceability, verification and validation info, and the other key metrics the FDA wanted to see, that would be pretty huge in terms of submission turnaround time. Best of luck guys.