The U.S. Food and Drug Administration (FDA) has urged advancement of new digital health policies. In a series of documents pertaining to digital health innovation, the FDA recommends expanding previous definitions of devices and guidance related to medical device software, redefining FDA regulatory oversight regarding software for both health care professionals and consumers, and suggests an approach for evaluating Software as a Medical Device (SaMD). Medical device software includes digital health technologies that inform everyday decisions, including fitness trackers, drug administration tracking, and tools that can help people be more informed about their health.
On December 8, 2017, the . . .