FDA是美国联邦政府中历史最悠久的综合性消费者保护机构,其使命是促进和保护公众健康。 这个范围很广,涵盖了食品、药品、生物制品、化妆品、动物和兽药、烟草,当然还有医疗器械和辐射产品,后两者由设备和辐射健康中心(Center for Devices and Radiological Health,简称CDRH)负责监管。 CDRH通过在医疗器械上市前评估其安全...
除了依据器材的风险来分级之外,依照器材的用途,FDA把现有医疗器材产品总共被分成16类、1700种,这些名单可以在《医疗器材与体外诊断产品分类名录》(Classification Names for Medical Devicesand InVitro Diagnostic Products)中查到。有一些在1976以前被分类为药品的体外诊疗器材已被...
Similar to drugs, medical devices in the United States go through a review process by the US Food and Drug Administration (FDA) before they can be marketed for use in patients. A medical device is used to diagnose, prevent, or treat a medical disease or condition without having any ...
–862-1050: device-specific requirements(特定设备要求) • Example: 876 - Gastroenterology and Urology Devices(肠胃科和泌尿科器械) • 21 CFR: Parts 1-99 –general medical requirements that also apply to medical devices(适用于医疗器械的一般医疗要求) 医疗器械注册流程: 医疗器械FDA验厂: 针对美国市...
从2018年初公布“医疗器械安全计划(Medical Device Safety Action Plan)”;11月,改革510(k)计划;12月4号,更新De Novo审查计划;12月14号又也推出了全新的安全技术计划(STeP);今年1月23号推出510(k)最终指南征集方案。 哪怕在政府关门期间,也没有放弃,而这些政策都只有一个指向,那就是医疗器械的安全问题。这些...
□ 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 ...
How to Get FDA Approval for Medical Devices To get FDA approval for your medical device, you’ll need to go through the following five steps. 1. Know Your Device’s Classification Medical devices fall into three classes: Class I Class II Class III You should know your device’s classificati...
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 ...
https://www.fda.gov/medical-devices/device-registration-and-listing/access-electronic-registration 比如,玻璃体切割产品。 首先属于,眼科产品,对应到21 CFR 886中。进而对应到886.4150。发现是II类,Special Control。 使用Product Classification数据库查询886.4150。
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation FDA新闻发布和报告:FDA Strategy for the Safety of Imported Food - https://www.fda.gov/food/importing-food-products-united-states/fda-strategy-safety-imported-food FDA Drug Recalls Report (...