What is software as a medical device (SaMD)? SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function. The international medical device regulat...
根据美国FDA的定义,医疗器械软件(Software as a Medical Device, SaMD)是指任何符合医疗器械法律定义的软件,包括一个或多个软件组件、部件、附件或仅由软件组成的器械。 国际医疗器械监管机构论坛(International Medical Device Regulators Forum, IMDRF)将医疗器械软件定义为:拟用于一个或多个医疗目的的软件,在执行这些...
2017年7月,FDA发布数字健康创新行动计划(Digital Health Innovation Action Plan, DHIAP ),其中阐述了对于确保高质量、安全和有效的移动医疗的指示,并宣布该计划与《作为医疗器械的软件指南》(Software as a Medical Device (SaMD) guidance)目的一致,同时FDA还公布关于数字健康软件预认证(Pre-certification , PreCert...
2017年7月,FDA发布了“数字健康创新计划”(Digital Health Innovation Action Plan, DHIAP ),包括颁布新法规实施相关的指导原则、重构数字健康产品监管体系和增长专业知识三个方面。其中阐述了对于确保高质量、安全和有效的数字医疗的指示,并宣布该计划与《作为医疗器械的软件指南》(Software as a Medical Device (SaMD...
FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical DeviceNeha K. Patel
Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff Document issued on December 8, 2017. The draft of this document was issued on October 14, 2016. For questions about this document, contact the Office of the Center Director at...
2021.11.04,FDA官网发布器械软件功能递交文档草稿指南,即,Content of Premarket Submissions for Device Software Functions,以替代2005年发布的指南Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,主要是为了更新FDA关于审核上市前递交文档中软件功能的想法。 此草稿指南,主要...
其中阐述了对于确保高质量、安全和有效的数字医疗的指示,并宣布该计划与《作为医疗器械的软件指南》(Software as a Medical Device (SaMD) guidance)目的一致。 截至2017年底,FDA已初步完成了一些“数字健康创新计划”中比较重要的工作。其中,“临床和患者决策支持软件”指导原则草稿、“21世纪治疗法案3060章导致的已有...
FDAstafforOfficeresponsibleforthisguidanceaslistedonthetitlepage. I.Introduction Off-the-shelf(OTS)Softwareiscommonlybeingconsideredforincorporationintomedical devicesastheuseofgeneral-purposecomputerhardwarebecomesmoreprevalent.Theuseof OTSSoftwareinamedicaldeviceallowsthemanufacturertoconcentrateontheapplication ...
• Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations 还包括如下回顾性审查指南: Retrospective Review List of Guidances for 1982, 1992, 2002, and 2012 1982 Final Guidances None 1992 Final Guidances ...