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...
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/medical-devices/device-advice-comprehensive-regulatory...
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...
从2002年开始,CDRH开始实施医疗器械使用费计划,受监管的设备行业向CDRH提供使用费,目的是推进监管决策。有关FDA对医疗器械监管历史的更多信息,请参考http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ucm618375.htm。 在我们整个注册过程当中,遇到的第一个问题,往往都是“我的产品是医疗器械吗?
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/med...
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...
(Feb. 21). Tammy Beckham, associate director of the resilient supply chain and shortages prevention program in FDA’s Center for Devices and Radiological Health, said FDA wants to find new opportunities for the agency to provide guidance and flexibility to manufacturers to help avoid shortages. ...
FDA Drafts Guidance on Inspections of Medical Device Establishments The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. ...
·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 FDA认可共识标准：四、FDA审核主体与要求 1.FDA的CDRH及其它中心对各种上市前申请进行审核，人因上市前评估组（Human Factors Premarket ...