随着科学知识的进步,该机构不断发展其法律,以确保以最有效的方式监管这些产品。 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...
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...
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要求和质量控制标准。标签和标志：《医疗器械标签和标志指南》（Guidance on Medical Device Labeling）：这个指南提供了医疗器械标签和标志的要求和标准。
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...
□ 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 ...
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...
Though only recently issued, the final guidance document on design considerations for home-use medical devices has been updated. Clarifying details have been added to sections pertaining to power mains and electromagnetic compatibility. As part of the Medical Device Home Use Initiative, the FDA recentl...
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FDA注册是强制性要求,普通FDA注册和产品列名是...
[2]http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ ucm109210.htm [3] 当前绩效显示截至2015年3月31日,FDA在目标审查时间内完成的行动的百分比。 [4] 审评进度显示了截至2015年3月31日,2014财年已采取行动的提交材料的数量,以及截至2015年...
(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. ...