See other comment about code reviews. In general though approval to market for particular indications is for one fixed configuration of a product, so your mode

See other comment about code reviews. In general though approval to market for particular indications is for one fixed configuration of a product, so your model parameters won't change. All of this is in the process of being hashed out, but I expect for a while at least if you are doing on-line learning it will be in non-clinical configurations only and you will end up releasing an update periodically. Depending on the changes this may need a new 510(k) or not, but would definitely need a formal release.