Or you could just not regulate medical devices, and if someone dies from a lethal dose of radiation from an X-ray machine then shrug they shouldn't have used that model I guess.
Is that really the only other choice here? Knocking down straw men will also not get us where we need to be.
Regulation can harm at least as much as it can help. Consider that regulation is based on ideas that people think might help a situation, then add in some partisanship. When coming up with ideas, how likely is it that an idea is not going to be a good one vs it will do some good?
Perhaps it would be better if there was some way to incrementally evaluate regulations. Perhaps if they had a defined lifetime to force re-evaluation in light of actual experience. This would prevent at least one negative aspect of regulation - locking into practices that were thought to be safe and maybe were, but are no longer the best/safest way to do things.