Uh, did you really just cite Therac 25 in favor of safety review? You do know that was the one that had a bug which slipped past review and killed some people, right?
Your overall point is well taken, but maybe put a little more thought into the examples you pick to support it...
I cited it as a thing that killed people and caused an industry overhaul in how things were reviewed... Remember that toyota just was forced to do somthing like this only a few years ago. I'd say the FDA has been cognizant of life threatening code for a lot longer.
Your overall point is well taken, but maybe put a little more thought into the examples you pick to support it...