That's indeed preposterous.
Same thing for the Theranos scandal. Financial regulators have done better for the safety of the patients than the FDA!
Other regulators in the world are worst sadly. The European framework is a mess - stuck in between 2 revisions of their dogma and in the hand of Notified Bodies which are running a private business of setting up the benchmark of safety and efficacy for health-tech, without any accountability mechanism in place.
I could go for hours on that.
Note that there are great people and initiative too (there's one coming up at the FDA on 14 OCT).
These institutions are sadly not "fit" for the upcoming intelligence explosion. Everyone is asking for more regulation of AI but we need to learn how to be efficient at regulating fast!!