美国FDA法规801 21 CFR Part 801 (up to date as of 10/06/2022)Labeling 21 CFR第801部分(截至2022年6月10日)标签 第801部分标签 子部分A一般标签规定 §801.1医疗器械;制造商...
TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUGADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICESPART 801 LABELING第 第 21 篇—— 食品和药品第一章食品药品监督管理卫生和公众服务部章 分章 H—— 医疗 器械T PART 801 标签Subpart A--General Labeling Provisions A ...
CFR 21 PART 801 MANSERVICES SUBCHAPTERH--MEDICALDEVICES PART801--LABELING SubpartA--GeneralLabelingProvisions Sec.801.4Meaningofintendeduses. Thewordsintendedusesorwordsofsimilarimportin801.5,801.119,and801.122refertotheobjectiveintentofthepersonslegallyresponsibleforthelabelingofdevices.Theintentis...
801 标识LABELING 803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方...
21CFRPart801medicaldeviceLabeling 系统标签: labelingdevicecfrmedicalpackercfcfr [CodeofFederalRegulations][Title21,Volume8][RevisedasofApril1,2012][CITE:21CFR801]6510(k)7|Registration&Listing8|AdverseEvents9|Recalls10|PMA11|Classification12|Standards13CFRTitle2114|Radiation-EmittingProducts15|X-RayAssembler...
801 标识LABELING 803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方...
D AND DRUGS标题 21-- 食品和药品R CHAPTER D I--FOOD D AND G DRUG ADMINISTR第I I 章 -- 食品和药品管理局N ATION T DEPARTMENT F OF H HEALTH D AND N HUMAN SERVICES卫生与公众服务部R SUBCHAPTER H H - - L MEDICAL DEVICESH H 分章- - 医疗器械T PART 1 801 LABELING第 801分 部分 ...
801 标识 LABELING 803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES ...
? 801 标识 LABELING? ? 803 医疗器械报告 MEDICAL DEVICE REPORTING? ? 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS? ? 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF ...
概述:《美国联邦法规》(CodeofFederalRegulations,CFR)第21篇“食品与药品”(Title21―FoodandDrugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务部食品与药品管理局(FoodandDrugAdministration,DepartmentofHealthandHumanServices)的规章;第9卷第2章第1300―...