U.S. Food & Drug Administration: Software As A Medical Device (SAMD) – Clinical Evaluation

On August 5, 2016, the U.S. Food and Drug Administration (FDA) released this clinical evaluation on the use of software as a medical device (SaMD). The evaluation was done to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety,  effectiveness and performance of software intended for medical purposes. Key themes from the evaluation include: the general principles and context of SaMD clinical evaluation; SaMD clinical evaluation methods, evidence, and appraisal; and level of evidence according to SaMD category . . .