当地时间6月13日,美国FDA发布了有关器械软件功能上市前提交内容的最终指南。 该指南取代了2005年发布的“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推荐申办方在上市前提交用于对器械软件功能进行审查的文档,基于...
当地时间6月13日,美国FDA发布了有关器械软件功能上市前提交内容的最终指南。 该指南取代了2005年发布的“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推荐申办方在上市前提交用于对器械软件功能进行审查的文档,基于...
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
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...
□ 2016年发布的《Applying Human Factors and Usability Engineering to Medical Devices》第2版指南文件。 □ 人因审核优先级最高的器械清单Listof Highest Priorities Device for Human Factor Review □ 医疗器械软件上市前递交指南Guidance for the Content of Premarket Submissions for Software Contained in Medical...
Software Functions: Lifecycle Management and Marketing Submission Recommendations.” In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should be included in marketing submissions for devices that include AI-enabled device software ...
Public Policy & Regulation attorney John Vaughan was quoted in a Bloomberg Law article analyzing new guidance from the U.S. Food and Drug Administration (FDA) that aims to expedite review of artificial intelligence (AI)-enabled medical devices and softwa
医疗器械软件上市前递交指南/Guidance for the Content of Premarket Submissions for Software Contained in MedicalDevices FDA指南-产品整个生命周期:输液泵上市前通知[510(k)]递交/ Guidance for Industry and FDA Staff - Total Product Life Cycle:Infusion Pump - Premarket Notification [510(k)] Submissions ...
FDA Issues Guidance on Off-the-Shelf Software Use in Medical Devices.Biomedical Safety & Standards
In mid-2017 the FDA announced its digital health innovation action plan2 and began implementing plan commitments by hiring digital health staff, launching its digital health software precertification pilot program3 (Pre-Cert pilot program), and releasing three new guidance documents—two of which dis...