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...
2023年4月3日,FDA发布于了《人工智能/机器学习支持设备软件功能的预定变更控制计划的营销提交建议的指南草案(Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, Draft Guidance)(以下简称“指南草案”)》...
This guidance document is applicable to the following premarket submissions for devices that contain software (including firmware) or programmable logic as well as software that is a medical device:1 · Premarket Notification (510(k)) including Traditional, Special, and Abbreviated · De novo ...
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
(AI/ML)-Enabled Device Software Functions ___ Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This draft guidance document is being distributed for comment purposes only. Document issued on April 3, 2023. You should submit comments and suggestions regarding this...
表1:Recommended Premarket Submission Documentation 医疗保健中各个领域都少不了相关医疗设备的支持,医疗设备与患者安全息息相关,所以医疗设备的网络安全无法忽视。我们回头看,2017年WannaCry8勒索软件影响了全球的医院系统和医疗设备,造成大量的患者的治疗诊断被延误。2020 年德国一家医院遭到勒索软件攻击,迫使病人转到另一...
• Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions • Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations ...
7. Electronic Submission Format 电子提交格式7.1 eCTD Specifications eCTD规范For information on how to incorporate datasets into the eCTD, please reference the Guidance to Industry Providing Regulatory Submissions in Electronic Format: Certain Human Pharmaceutical Product Applications and Related Submissions ...
– Referenced the Guidance to Industry Providing Regulatory Submissions in Electronic Format: Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications and added footnote Section 7.2 (ECTD Sample Submission) – Change header to align ...
Exposure Response Relationships; Guidance for Industry 暴露反应关系.工业指南 General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products 药物和生物制品儿科研究的一般临床药理学 Pharmacogenomic Data Submission 药物基因组数据提交 ...