Comment Re:What about networks (Score 0) 234
I do wonder if they have to go through a full FDA acceptance period for software/firmware updates? I suspect that could be an issue. --
Changing firmware without full design review and V&V is a big NO-NO...they can get their tits in a big ringer. My old company nearly did when a "software engineer" made a change w/o review. FDA got real ugly! Not sure if it requires a new 510K at this point but all SOPs have to be fulfilled and documents in place just as changing an internal component would be. It would be expensive in any case and the suits are loathe to spend another penny on them, plus the original development group has often been disbanded by that time. Lots of internal inertia!