1. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 8, 2023 Subject(s): Biological evaluation of medical devicesDevice ApprovalEquipment and Supplies -- adverse effectsGovernment RegulationGuidelines as TopicUnited States
