However, making sure that AI-enabled medical software is both safe and effective presents hurdles for both device manufacturers and regulatory bodies. TheFDA guidance, a draft of which was published last year, "is intended to provide a forward-thinking approach to promote the development of ...
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 ...
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
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...
https://www.fda.gov/food/guidanceregulation/retailfoodprotection/foodcode/default.htm FDA Facts About Current Good Manufacturing Practices (CGMPs) - https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-about-current-good-manufacturing-practices-cgmps FDA Overview of Device Regulation - https:...
On Jan. 7, 2025, the FDA issued itsdraft guidance, “Artificial Intelligence-Enabled Device 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 In its latest draft guidance on medical devices, the FDA provides recommendations on the documentation and information that should...
□ 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...
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...
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...
Here are summaries of the latest FDA guidance and communications on medical devices:In January, the FDA updated the final guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile. The FDA now considers vaporized hydrogen...