2.4《家族吸烟预防和烟草控制法案》(Family Smoking Prevention and Tobacco Control Act): 2009年生效,授权FDA全面监管烟草制品。2.5《药品和医疗器械使用费修正案》(Prescription Drug User Fee Act, Medical Device User Fee Act): 允许FDA向药企和医疗器械企业收取新产品审评费,以加快审批进程。2.6《孤儿药法...
This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act (FDAMA). This guidance addresses what statutory ...
Medical devices in South Korea are managed by Medical Device Act and controlled by The Ministry of Food & Drug Safety (MFDS) or formerly Korea FDA. Under the jurisdiction of the Act, requirements for medical devices are provided in numerous various titles of guidelines. Below is a list of th...
Tracking incident reports The HeartMate 3 is not the only device whose safety profile is hard to ascertain in MAUDE, Dhruva said. The information in the FDA database is insufficient to give patients an adequate understanding of any medical device's safety risks and reflects "the overall weakness...
美国fda医疗器械中英文翻译（FDA medical devices in the United States）FDA medical devices in the United States 800 general rules GENERAL 801 identifies LABELING 803 medical device report MEDICAL DEVICE REPORTING 806 medical devices; correction and movement reports; MEDICAL DEVICES; REPORTS OF CORRECTIONS ...
FDA的器械官费属于一个叫做MDUFA(The Medical Device User Fee and Modernization Act)的法律框架, 这个框架要求每隔5年重新检讨一次,对FDA的发展和收费进行调整。这个MDUFA计划已经进行了4次,2023年到2027年是第五次的检讨和调整,称为MDUFA V。检讨和调整的流程是: ...
美国FDA是Food and Drug Administration 的缩写，即美国食品药品管理局。准确来说，美国FDA对大部分产品不做认证，但企业必须要做FDA备案或者注册，否则美国FDA有权对货物采取行动，包括对货物扣留、拒绝入境甚至销毁、企业被列入黑名单等。受美国FDA管辖的产品有食品、食品接触材料、药品、药品成分、化妆品、...
FDA—medical device news corner: The safe medical device act of 1990doi:10.1002/jab.770020112NaserSalmanWileyJournal of Applied Biomaterials
814医疗器械的上市前批准PREMARKETAPPROVALOFMEDICALDEVICES 820质量体系规章QUALITYSYSTEMREGULATION 821医疗器械跟踪要求MEDICALDEVICETRACKINGREQUIREMENTS（只专注于医疗器械领域） 822上市后监视POSTMARKETSURVEILLANCE 860医疗器械分类程序MEDICALDEVICECLASSIFICATIONPROCEDURES 861性能标准制定程序PROCEDURESFORPERFORMANCESTANDARDSDEVELOPMENT...
814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES 820 质量体系规章 QUALITY SYSTEM REGULATION 821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS 822 上市后监视 POSTMARKET SURVEILLANCE 860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861 性能标准制定程序 PROCEDURES FOR PERFORMANCE...