> Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via

> Yes but in a certain sense for many digital health companies this is already true, because they’re 510(k) exempt and FDA’s oversight occurs retroactively via QMS auditing 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.