FDA ISSUES GUIDANCE CONTENT OF PREMARKET SUBMISSIONS FOR DEVICE SOFTWARE FUNCTIONS

The FDA released new guidance for the Content of Premarket Submissions for Device Software Functions [1] in June 2023. This guidance replaces the preexisting guidance from May of 2005. Since then, technological advances have caused software to become an important part of medical devices.  The final guidance moved to a simplified risk-based approach to determine […]

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 […]