1. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017 Subject(s): Equipment and Supplies -- standardsEquipment Design -- standardsEquipment Safety -- standardsDevice ApprovalEquipment FailureInformation DisseminationRisk ManagementHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Use of serological tests to reduce the risk of transmission of Trypanosoma cruzi infection in blood and blood components Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, December 2017 Subject(s): Blood DonorsChagas Disease -- bloodChagas Disease -- transmissionDisease Transmission, Infectious -- prevention & controlDonor SelectionSerologic TestsTrypanosoma cruziChagas Disease -- prevention & controlRisk ManagementHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. Q9(R1): : quality risk management : guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023 Subject(s): Drug DevelopmentDrug IndustryGovernment RegulationRisk ManagementUnited States
