1. Deciding when to submit a 510(k) for a software change to an existing device: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017 Subject(s): Device Approval -- standardsSoftware -- standardsComputer SecurityEquipment Design -- standardsEquipment Safety -- standardsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Cybersecurity in medical devices: quality system considerations and content of premarket submissions : guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 27, 2023 Subject(s): Computer SecurityDevice ApprovalEquipment SafetyGovernment RegulationMedical Device LegislationUnited States
