Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Software as a Medical Device (SaMD): Clinical Evaluation.'' This guidance was prepared as part of the FDA's international convergence efforts under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The guidance, informed by global and U.S. public comments, pertains to Software as a Medical Device (SaMD) and focuses on principles of clinical evaluation, which include establishing the scientific validity, clinical performance, and analytical validity for SaMD. The guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD.