21. Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, December 8, 2017 Subject(s): Equipment and Supplies -- standardsReproducibility of ResultsSoftware -- standardsInternational CooperationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
