NOT DEVICES ANYMORE: THE FDA REDEFINES SOFTWARE IN EIGHT CLASSIFICATIONS

The FDA has officially excluded certain software from the definition of a medical device (Final Rule: 86 FR 20278). Eight regulations are being amended. The classifications include Clinical Chemistry and Clinical Toxicology Devices under Part 862, Immunology and Microbiology Devices under Part 866, General Hospital and Personal Use Devices under Part 880, Obstetrical and Gynecological […]