Having been through an FDA process in a prior startup (although far from central at it; my role was at the outskirts), I can say the FDA is not ridiculously over-conservative. We did human pilots in another country, which was less bureaucratic. The processes there were both faster and more conservative in terms of safety. Doctors would look over our data and protocols and make reasonable decisions.

The FDA process took a long time, but wasn't all that effective at guaranteeing safety either. There was a ton of process.

I think you're attributing far too much rationality to an administrative government process.