[negative_zero]

Ethics approval for a medical device is a completely different thing from EMC regulations (which is what normally people mean when talking about FCC and CE for a device).

"I can't imagine having to have each hardware iteration certified by the FCC."

Depending on your device and the magnitude of the changes, this might simply be the reality for you. This is why I always try to tell people that you need compliance at the table from the start or you really risk making life very difficult for yourself. Find yourself a compliance specialist or at least a hardware engineer who is familiar with the regulations.

EDIT: You CAN'T just iterate ad-infinitum for free without consequence like you do for software. This thinking and approach, only works in software land. No where else.

It would be ridiculous to build a house and having the builder iterate on your house over 2-3 years to finish it, no?