HOW WILL THE FDA REGULATE MEDICAL DEVICE SOFTWARE? (Orthopedics This Week)
The FDA wants to be crystal clear about how it will regulate medical device software that help doctors make decisions about patient care. Device software functions may include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD)."
The 21st Century Cures Act removed certain software functions from the definition of a medical device. But the Act gave the FDA the power to decide the definition.
There was uncertainty by makers of device software, so the FDA issued new guidelines on September 26, 2...
The Orthopedics Industry 
