[AnimalMuppet]

Sure, that's all true. I'm looking at the "simpler argument" part.

It's especially true if you're saying "This new device is just like our previous device, with these few small changes". (I forget what that's called, but you can do a lot less paperwork if that's true.) But if you start doing memory allocations where you never did before, they're probably going to want to apply higher scrutiny to your entire software. That's... painful.

[ska]

You are possibly thinking about note-to-file (which isn’t quite the process any more, but similar)

But it is worth pointing out, FDA (or other national body) isn’t doing code reviews. They are mostly interested in process , and how you follow it. The place where this really interacts s is hazard analysis, and then it’s just up to you to demonstrate your checks and balances.