FDA Developing Requirements For Evaluation Of Tech-Enabled Clinical Algorithms

The U.S. Food and Drug Administration (FDA) is developing requirements for clinical algorithms, referred to as software-as-a-medical device (SaMD), in order to establish principles for clinical evaluation of scientific validity, clinical performance, and analytical validity. A SaMD is not a device that directly contacts a consumer; rather, a SaMD is an algorithm that analyzes data inputs and provides data output to a user to support clinical management, diagnosis, or treatment in non-serious, serious or critical health care situations or conditions. The data inputs analyzed by the SaMD usually come from other physiological measurement devices or . . .