FDA Final Guidance: Software As A Medical Device (SAMD): Clinical Evaluation

In this document released on December 8, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance to industry about how it will address software intended for use in clinical medical applications. Overall, this type of technology is called "software as a medical device." Medical device software includes digital health technologies that inform everyday health decisions, including fitness trackers, drug administration tracking, and tools that can help people be more informed about their health . . .