The FDA issued a final rule that updates the descriptions of eight software functions that don’t meet the definition of medical device under the 21st Century Cures Act, effectively removing certain software from regulation.

AdvaMed is urging the Centers for Medicare and Medicaid to implement the Medicare Coverage of Innovative Technology (MCIT) rule without delay after CMS announced it would postpone a final ruling on the regulation that would provide immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology.