Under the new Rule 10a, software designed to provide data used to make decisions for diagnostic or therapeutic purposes is now classified as Class IIa. This also applies to software that previously fell under Class I.
However, if those decisions have implications that may directly or indirectly cause death or lead to an irreversible deterioration of health, the software is now classified as Class III.
This is new for software that is neither part of a Class III medical device nor controls or influences such a device.