11. Unique device identification: convenience kits : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, April 26, 2019 Subject(s): Equipment and Supplies -- standardsProduct Labeling -- standardsEquipment ReuseProduct Packaging -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
12. Changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2019 Subject(s): Equipment and Supplies -- standardsSoftware -- legislation & jurisprudenceElectronic Health RecordsHealthy LifestyleHospital Information SystemsMobile Applications -- legislation & jurisprudenceSoftware -- classificationHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.United States.
13. Process to request a review of FDA's decision not to issue certain export certificates for devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, November 14, 2019 Subject(s): Commerce -- legislation & jurisprudenceEquipment and Supplies -- standardsDevice Approval -- legislation & jurisprudenceEquipment SafetyHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.
