Looking it up, the exception where it is required is specifically for clinical investigations regulated by the Food and Drug Administration.
Netflix personalized recommendations affect only the individual, not those around them who are not using Netflix.
But this isn't that crazy? Most businesses require government approval for changes that have community effects... that's the entire point of government. Stuff like construction permits and regulation around structures, water usage, pollution, building architecture. Mining companies are required to assess environmental impacts. Companies making RF devices need to get confirmation on how the devices affect people and other devices.
And that's not even considering market share/monopoly status, which also regularly invites more scrutiny.
Like compare changing live routing to publishing a paper map showing alternate routes.
In either case it seems to me that the vehicle operator should be most responsible for the impact of the route that they use.