美国FDA 医疗器械体系法规QSR820中英文对照(二)

Subpart A--GeneralProvisions 总则Sec. 820.1 Scope 范围(a) Applicability. 适用性(1) Current good manufacturing practice (

Subpart A--GeneralProvisions 总则

Sec. 820.1 Scope 范围


(a) Applicability. 适用性

(1) Current good manufacturing practice (CGMP) requirements areset forth in this quality system regulation. The requirements in this partgovern the methods used in, and the facilities and controls used for, thedesign, manufacture, packaging, labeling, storage, installation, and servicingof all finished devices intended for human use. The requirements in this partare intended to ensure that finished devices will be safe and effective andotherwise in compliance with the Federal Food, Drug, and Cosmetic Act (theact). This part establishes basic requirements applicable to manufacturers offinished medical devices. If a manufacturer engages in only some operationssubject to the requirements in this part, and not in others, that manufacturerneed only comply with those requirements applicable to the operations in whichit is engaged. With respect to class I devices, design controls apply only tothose devices listed in 820.30(a)(2). This regulation does not apply tomanufacturers of components or parts of finished devices, but suchmanufacturers are encouraged to use appropriate provisions of this regulationas guidance. Manufacturersof human blood and blood components are not subject to this part, but aresubject to part 606 of this chapter.

1)本质量体系法规阐明了现行生产质量管理规范(CGMP)的要求。本标准的要求管控所有的用于人用的终产品(器械)的设计、生产、包装、贴签、存储、安装和服务的方法、装置、控制。本标准要求的意图是保证成品器械安全有效并符合美国联邦食品,药品和化妆品法案。本标准确定的基本要求适用于医疗器械成品生产商。如果制造商从事的仅仅是本标准有要求服从的某些过程而不是其他过程,制造商仅需要符合适用于其实施的过程的要求即可。对遵从于I类器械要求的器械来讲,设计控制只适用于那些在820.30a)(2)中列出的设备。本规例不适用于元件或部件的成品制造商,但鼓励这些制造商使用本标准的适当条文作为指南来使用。人体血液和血液成分的生产商是不受本标准的控制,但应遵循本章606部分法规的要求。

Manufacturers of human cells, tissues, and cellular andtissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, thatare medical devices (subject to premarket review or notification, or exemptfrom notification, under an application submitted under the device provisionsof the act or under a biological product license application under section 351of the Public Health Service Act) are subject to this part and are also subjectto the donor-eligibility procedures set forth in part 1271 subpart C of thischapter and applicable current good tissue practice procedures in part 1271subpart D of this chapter.

In the event of a conflict between applicable regulations inpart 1271 and in other parts of this chapter, the regulation specificallyapplicable to the device in question shall supersede the more general.

在本章1271.3d)中界定清楚的人体细胞、组织和以细胞和组织为基础的产品(HCT/Ps)的生产商(适用于上市前审查或通知,或豁免通知,本法案器械规定申请下的、公共卫生服务法第351条规定的生物制品许可证申请下的)适用于本标准的要求、也适用于本章1271 C部分额献血资格程序和本章1271D部份的现行良好组织实践规范。当出现1271部分相应法规与本章其他部分法规冲突时,特定应用于考虑之中的器械法规将取代更多的一般原则。

(2) The provisions of thispart shall be applicable to any finished device as defined in this part,intended for human use, that is manufactured, imported, or offered for importin any State or Territory of the United States, the District of Columbia, orthe Commonwealth of Puerto Rico.

2)本部分的规定将适用于任何本部分定义下的供人类使用的成品器械,不论其在美国(包含美国的任何州或地区、哥伦比亚特区和波多黎各自治区)生产、还是进口或提供进口的产品。

(3) In this regulation theterm "where appropriate" is used several times. When a requirement isqualified by "where appropriate," it is deemed to be"appropriate" unless the manufacturer can document justificationotherwise. A requirement is "appropriate" if nonimplementation couldreasonably be expected to result in the product not meeting its specifiedrequirements or the manufacturer not being able to carry out any necessarycorrective action.

3)在本法规中“适用时”出现过多次。除非制造商以文件的形式证明其理由充分,否则根据"whereappropriate,"只要认定有需求,这个需求就被认为是“适用的”。如果不执行预期结果将会导致产品不符合其特定要求,这时需求是“适用的”;或生产商不能实施必要的纠正措施,这时需求是“适用的”。

(b) The quality systemregulation in this part supplements regulations in other parts of this chapterexcept where explicitly stated otherwise. In the event of a conflict betweenapplicable regulations in this part and in other parts of this chapter, the regulationsspecifically applicable to the device in question shall supersede any othergenerally applicable requirements.

b)除另有明确规定外,本部分的质量体系法规是本章其他部分法规的补充。当本部分适用性法规与本章的其他部分法规发生冲突时,专属于考虑之中的器械法规将取代一般性适用法规要求。

(c) Authority. 权限

Part 820 isestablished and issued under authority of sections 501, 502, 510, 513, 514,515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352,360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failureto comply with any applicable provision in this part renders a deviceadulterated under section 501(h) of the act. Such a device, as well as anyperson responsible for the failure to comply, is subject to regulatory action.

PART820是在(501, 502, 510, 513, 514, 515, 518, 519, 520, 522,701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,360i, 360j, 360l, 371, 374, 381, 383)章节下建立和出版。根据501h)章节法案的要求,如果不符合本部分的任何适用条款将视为伪劣品。像这样的器械及对不符合负责的人都将受到法律起诉。

(d) Foreign manufacturers. 国外制造商

If amanufacturer who offers devices for import into the United States refuses topermit or allow the completion of a Food and Drug Administration (FDA)inspection of the foreign facility for the purpose of determining compliancewith this part, it shall appear for purposes of section 801(a) of the act, thatthe methods used in, and the facilities and controls used for, the design,manufacture, packaging, labeling, storage, installation, or servicing of anydevices produced at such facility that are offered for import into the UnitedStates do not conform to the requirements of section 520(f) of the act and thispart and that the devices manufactured at that facility are adulterated undersection 501(h) of the act.

如果向美国出口器械的国外制造商拒绝允许或同意FDA对国外的工厂实施为确定器械是否符合本章节的法规(Part820)所进行的检查,可按section 801(a)条款对其提出诉讼。那么其设计、生产、包装、标签、贮存或服务中使用的方法设施以及控制将会被认为不符合本法令section 520(f)和本部分(Part820)的要求,同时可依据本法令section 501(h)条款裁定在此工厂内制造的产品为伪劣产品。

(e) Exemptions or variances. 豁免或特别许可

(1) Anyperson who wishes to petition for an exemption or variance from any device qualitysystem requirement is subject to the requirements of section 520(f)(2)of theact. Petitions for an exemption or variance shall be submitted according to theprocedures set forth in 10.30 of this chapter, the FDA's administrativeprocedures. Guidance is available fromthe Food and Drug Administration, Center for Devices and Radiological Health,Division of Small Manufacturers, International and Consumer Assistance, 10903New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002,1-800-638-2041 or 301-796-7100, FAX: 301-847-8149.

(1)任何人希望得到质量体系需求豁免或特别许可,应符合法令520(f)要求。审请豁免或特别许可的申请应当依据设置在本章10.30中的程序进行——FDA行政程序。可以从器械和辐射健康中心和小型制造商援助处获得指导。地址:10903 New Hampshire Ave.,Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-800-638-2041 or 301-796-7100,FAX: 301-847-8149.

(2) FDA may initiate andgrant a variance from any device quality system requirement when the agencydetermines that such variance is in the best interest of the public health.Such variance will remain in effect only so long as there remains a publichealth need for the device and the device would not likely be made sufficientlyavailable without the variance.

(2)当有关部门确定此种改变对公共健康非常有利时,FDA可以发起和允许来源于任何质量体系要求的特别许可。只要公众健康确实需要该器械,这样的特别许可将会一直维持有效。若没有特别许可,器械将不可能被生产,并得到充分的应用。

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