FDA指导文件-医疗设备中现成软件的使用Off-The-Shelf-Guidance_0.pdf,Contains Nonbinding Recommendations Off-The-Shelf Software Use in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on August 11, 2023. Document o
launching its digital health software precertification pilot program3 (Pre-Cert pilot program), and releasing three new guidance documents—two of which distinguish between device types that are low-risk and, therefore, no longer required to undergo pre-market review,4 and one which outlines new ...
该指南取代了FDA于2005年5月11日发布的“医疗器械中包含的软件上市前提交内容指南 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”,并更新了FDA关于其建议申办者在上市前提交的、用于对设备软件功能进行审查的文档,基于风险的方法的想法。 关于此最终指南的两点要点: 1...
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...
2可登录以下网址获取:/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices。3可登录以下网址获取:/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices。 根据“...
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...
The U.S. Food and Drug Administration (FDA) has announced the priority, “A-list” of medical device guidance documents it intends to publish for fiscal year 2016, as well as a secondary, “B-list” of guidance the agency plans to publish as guidance-development resources permit. ...
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...
in Medical Devices: Quality System Considerations and Content of Premarket Submissions—Guidance for ...