Fundamental disconnect
On the face of things, the FDA recommendations make a great deal of sense. There is a disconnect however between many of the people developing these technologies who frequently rely on the mark 0 eyeball - does it appear to provide 'better' performance than what came before and those in the hard real-time development community who demand a little more than that - just because some addition to (say Boeings flight management software) looks superficially better and possibly for trivial reasons, does not remove the responsibility of proper analysis and testing. Difficult to achieve with many 'learning' techniques.
I would hope the latter prevail.