To an extent, but only if the software meets the criteria for being legally classified as a "medical device". And at the lower classification levels the regulations are very light. You don't necessarily have to prove any level of reliability or usability.
Ex employee of the division of imagine devices and software reliability here. I have nothing to add, and I'm not qualified to confirm or deny your comment. Just interesting to see a mention of my past life
https://www.fda.gov/medical-devices/classify-your-medical-de...