美国FDA 法规 21 CFR 807-Subpart E--Premarket Notification Procedures 上市前的通知程序.pdf,FDA Home3 Medical Devices4 Databases5 CFR - Code of Federal Regulations Title 21 New Search Help6 | More About 21CFR 7 [Code of Federal Regulations] [Title 21, Volu
21 CFR第807部分要求您向FDA注册。它还要求您列出您的设备。 市场前通知510(K)(21 CFR Part 807 SubPart E) 21 CFR第807部,副部E适用于II类器件。II类设备的风险从低到中度不等.这种分类通常用于较成熟的产品,如X射线机. 市场前批准申请(21 CFR第814部) 21 CFR第814部分适用于III类装置。III类设备的...
美国医疗器械法规CFR-2021-title21-vol8-part807.docx,Food and Drug Administration, HHS Pt. 807 device. Records required to be main- tained under paragraph (b) of this sec- tion must be transferred to the new manufacturer or importer of the device and maint
(一)除本节(e)(2)(ii)段规定外,您可以依赖另一实体根据本节(e)(1) 段执行的供应商验证活动,前提是您审查和评估结果根据本节(e)(3) 段进行的这些活动。 (二)您不得依赖外国供应商本身或外国供应商的员工来执行供应商验证活动,除非根据本节(e)(1)(ii) 段对食品进行抽样和测试。 (3)审查验证活动的...
FDA21CFR812IDE中文简译(fda临床试验规定) PART812—INVESTIGATIONAL DEVICE EXEMPTIONS 调查的机械豁免 Subpart A—General Provisions Sec. 812.1Scope.范围 812.2Applicability.申请 812.3Definitions.定义 812.5Labeling of investigational devices.标记调查用的机械...
unless FDA has noti- investigated in accordance with the in- fied a sponsor under §812.20(a) that ap- dications in the labeling FDA reviewed proval of an application is required: (1) An investigation of a device other under subpart E of part 807 in deter- than a significant risk device...
求翻译:Part 21 CFR 801 Subpart D是什么意思?待解决 悬赏分:1 - 离问题结束还有 Part 21 CFR 801 Subpart D问题补充:匿名 2013-05-23 12:21:38 部分21 CFR 801子部分D 匿名 2013-05-23 12:23:18 部分21CFR801subpart d 匿名 2013-05-23 12:24:58 第21部分CFR 801子部分D 匿名 20...
As servicing is not required of all medical devices, this subpart of the regulations is one of the more commonly excluded regulations from an organization's quality system requirements.
(4),FDAwilldisclosetoapatientwhorequestsareportalltheinforma-tioninthereportconcerningthatpa-tient.PART807—ESTABLISHMENTREG-ISTRATIONANDDEVICELISTINGFORMANUFACTURERSANDINI-TIALIMPORTERSOFDEVICESSubpartA—GeneralProvisionsSec.807.3Definitions.SubpartB—ProceduresforDeviceEstablishments807.20Whomustregisterandsubmitade-...