国内正在注册的体外诊断试剂,在FDA上市的情况 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载。 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 二、医疗器械FDA验厂 美国FDA注册,FDA510K,FDA验厂,针对美国市场,其中...
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
临床试验：《医疗器械临床试验指南》（Guidance on Clinical Trials for Medical Devices）：这个指南提供了关于如何进行医疗器械临床试验的信息，包括试验设计、数据收集等。质量控制和cGMP：《医疗器械生产和质量控制指南》（Guidance on Medical Device Manufacturing and Quality Control）：这个指南解释了医疗器械的cGMP要求...
□ 医疗机构中的再加工医疗器械:验证方法和标识Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling □ 医疗器械患者标识指南Guidanceon Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers □ 器械建议的标识要求Labeling requirements from Device Advice ■...
网址:https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents 在该链接中,你可查询贯穿各领域FDA的指南,包括不限于产品特定指南、不良事件相关指南、递交方式相关指南、临床相关指南、进出口相关指南等。 03 已上市产品数据库 510(k)数据库网址:https://www.accessdata.fda.gov/scripts/cdrh/cfdo...
Search for FDA Guidance Documents | FDA 根据FDA《良好指南制定规范》,“指南”是指为FDA员工,注册申请人和公众准备的,用来描述FDA就某个法规议题所作出解释或指导的文件。在这个数据库中,用户可以随时检索到FDA的CDRH部门发出的医疗器械相关的指南。 03 ...
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...
The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique...
given by the FDA official was that applying this guidance for AI/ML in the cloud will look different from AI/ML that’s part of a medical device. It is interesting to note that, while AI/ML is becoming more common in medical devices, theFDA cybersecurity guidanceitself does not mention ...
植入心脏起搏器的这个也有Guidance。 对于有Device-Specific Guidance的产品,应该满足Guidance的相关要求,否则可能在受理的时候被Refuse To Accept - RTA。 (第6点的相关内容,也可以参考FDA 网页介绍 How to Study and Market Your Device) (https://www.fda.gov...