整理fda金属等离子喷涂涂层测试指南.docx

1、整理fda金属等离子喷涂涂层测试指南Guidance for Industry and for FDA Reviewers/Staff医疗器械产业和FDA全体职员指南Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements 支持复议的售后监测要求的骨科植入物的金属等离子喷涂涂层测试指南Document issued on: Feb

2、ruary 2, 2000 发行日期：2000.2.2This document supersedes Draft Guidance release of Guidance for Industry on the Testing ofMetallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration ofPostmarket Surveillance Requirements, dated February 22, 1999 本文件替代1999年2月22日发行的支持复议的售后监测要求的骨科植入物的

3、金属等离子喷涂涂层测试指南的草案U.S. Department Of Health And Human Services美国健康与人类服务部门Food and Drug Administration FDACenter for Devices and Radiological Health（CDRH）器械和放射性健康中心Postmarket Surveillance Studies Branch售后监测研究机构Division of Postmarket Surveillance售后监测司Office of Surveillance and Biometrics监测和生物学测定办公室Prefa

4、ce前言Public CommentComments and suggestions may be submitted at any time for Agency consideration to Postmarket Surveillance Studies Branch, HFZ-543, Office of Surveillance and Biometrics, 1350 Piccard Drive, Rockville MD 20850. Comments may not be acted upon by the Agency until the document is next

5、revised or updated. For questions regarding the use or interpretation of this guidance contact Daniel S. McGunagle at (301) 594-0643 or mailto:dsmcdrh.fda.gov公众评论评论和提议在任何时候都可能被提交给售后监测研究机构，HFZ-543、监测和生物学测定办公室，1350 Piccard Drive和Rockville MD 20850以供考虑。机构不会对评论采取措施除非文件被修订或更新。对本指南的使用或说明有任何疑问可联系Daniel S.

6、McGunagle 电话(301) 594-0643 或 mailto:dsmcdrh.fda.gov Additional CopiesWorld Wide Web/CDRH home page at http:/www.fda.gov/cdrh/postsurv/plasmaspry.pdf, or CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 946 when prompted for the document shelf number.额外备份世界网络/CDRH国内网页http:/www.f

7、da.gov/cdrh/postsurv/plasmaspry.pdf,，或查询电话-800-899-0381和301-827-0111，提示文件架编号时报出946。Guidance1 for Industry on the Testing ofMetallic Plasma Sprayed Coatings onOrthopedic Implants to SupportReconsideration of PostmarketSurveillance Requirements 支持复议的上市后监测要求的骨科植入物的金属等离子喷涂涂层测试指南1This guidance document s

8、upersedes an earlier document titled Draft Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements. The previous version was released for public comment on February 22, 1999. In preparing this

9、document, consideration was given to comments submitted to earlier drafts of this document.本指南替代了早先的“支持复议的售后监测要求的骨科植入物的金属等离子喷涂涂层测试指南的草案”。草案于1999年2月22号发布供公众讨论。在准备本文件时，充分考虑了已提交的公众对该文件先前的草案的评论。I. BACKGROUNDOn February 21, 1992, the Food and Drug Administration (FDA) reclassified the metallic porous coa

10、ted hip prosthesis intended for biological (i.e., cementless) fixation from class III (premarket approval required) to class II (see 21 CFR 888.3358). The reclassified porous coated hip prostheses achieved cementless fixation by using metallic porous coatings. Sintering, or diffusion bonding, proces

11、ses were used to attach the metallic porous coatings to the solid metal of the prostheses. On February 15, 1994, the Center for Devices and Radiological Healths (CDRH) Orthopedic and Rehabilitation Devices Branch (ORDB) determined that hip prostheses intended for biological fixation through porous c

12、oatings applied by plasma spray production methods can be substantially equivalent to the reclassified porous coated hip prosthesis. As part of the latter decision, CDRH, using the then existing authority of section 522(a)(1)(C) of the Food, Drug and Cosmetic Act (the act), required manufacturers of

13、 plasma sprayed porous coated hip prostheses to conduct postmarket surveillance of their devices. The required postmarket surveillance consisted of prospective, long-term, follow-up of a population of patients receiving cementless implantation of the manufacturers plasma spray coated hip prosthesis.

14、 The objective of patient follow-up was to determine the long-term revision rate for each manufacturers plasma sprayed porous coated hip prosthesisI. 背景1992年2月21日FDA将能够达到生物固定（即非骨水泥）的金属多孔渗水涂层髋关节假体从类（上市前需得到批准）调成类（见21CFR 888.3358）。重新分类后的多孔渗水涂层髋关节假体通过使用金属多孔渗水涂层能够骨水泥固定。烧结或扩散焊过程被用于使金属性多孔渗水涂层黏附于关节假体的金属固体。1

15、994年2月15日CDRH和ORDH确定用等离子喷涂生产方法进行多孔渗水涂层的具有生物固定性的髋假体可完全等同于重新分类后的多孔渗水涂层髋假体。作为后一个决定的一方，CDRH应用现有的权威著作食品，药物和化妆品法（该法）522（a）（1）（C）部分，要求等离子喷涂多孔渗水涂层髋关节假体的制造商对他们的设备进行上市后的监测。上市后监测要有前瞻性，长远性以及对接受制造商的等离子喷涂涂层髋假体的骨水泥植入的病人的跟踪。病人跟踪的目的是为了确定每个制造商的等离子喷涂涂层髋假体的长远的调整率。1This document is intended to provide guidance. It repre

16、sents the Agencys current thinking on the above. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.1本文件意在提供指导。它只代

17、表了代理机构目前对以上所述的想法。并不会产生或是赋予任何人任何权利并且也不会约束FDA或公众。任一方法都可能会被使用只要这种方法能够满足法规要求。When CDRH required postmarket surveillance, it believed that the term plasma spray represented a single manufacturing technique that produced a single form of coating, having a single set of material properties. Since that time

18、, CDRH has come to recognize that plasma spray manufacturing methods are a subset of a larger group of thermal spray metallic coating production methods. CDRH now recognizes that thermal spray coating methods, including plasma spray methods, can produce a wide range of metallic coatings with a wide

19、range of material properties. 当CDRH要求售后监测时，它认为等离子喷涂这个词代表一种能够生产单一形式涂层，具有一套单一材料特性的制造技术。自那时起， CDRH已经认识到等离子喷涂的制造方法只是众多热喷涂金属涂层生产方法中的一种。 现在CDRH认识到，热喷涂方法，包括等离子喷涂方法，能产生具有广泛的材料特性的多种金属涂层。The CDRH does not believe that postmarket surveillance is necessary for thermal spray coated hip prostheses whose coatings

20、have mechanical properties equal to, or better than, sintered or diffusion bonded porous coatings. CDRH is willing to reconsider, on a case-by-case basis, its orders requiring postmarket surveillance of a plasma spray coated hip prosthesis. Manufacturers of plasma spray coated hip prostheses who rec

21、eived an order to conduct postmarket surveillance are invited to apply for reconsideration of the surveillance order. A request for reconsideration should include all of the information identified in this guidance document, should be addressed to the Required Postmarket Surveillance file number, and

22、 should be sent to:CDRH认为售后监测对于那些涂层力学性能等同或优于烧结或扩散黏结多孔涂层的热喷涂涂层髋假体是没有必要的。在连续案例的基础上，CDRH会重新考虑它的要求热喷涂涂层髋假体进行售后监测的规定。接到售后监测命令的热喷涂涂层髋假体制造商被邀请申请复议监察秩序。复议请求应包含所有本指南文件中可识别的信息，并给出售后监测文件编号提交给： Center for Devices and Radiological Health CDRH Postmarket Surveillance Document Mail Center售后监测文件邮寄中心 Room 330Q (HFZ-

23、544) 330Q（HFZ-544）房间1350 Piccard Drive Rockville, MD 20850A request for reconsideration may be supported by data or information previously submitted to CDRH. Previously submitted data or information , with the exception of the comparative testing, may be resubmitted or incorporated by reference. If

24、data or information is incorporated by reference, applicants should state the document number, the date of submission, the section, chapter, or attachment number, and page number of the information. CDRH believes that requests for reconsideration that contain copies of all necessary data and informa

25、tion will be easier and faster to review.复议请求可能会被先前提交给CDRH的数据和资料所支持。先前提交的数据和资料除了对比测试以外可能会被重新提交或合并于参考书目。如果资料或信息被合并于参考数目中，申请人应说明文件编号，提交日期以及所在的章，节或附件，页码。CDRH认为包含所有必要信息的复议请求会更易，更快检查。CDRH requests that manufacturers of joint prostheses having metallic thermal spray coatings include data from the test met

26、hods described in this document in future 510(k)s for new products. CDRH intends to use the data to determine if new thermal spray coatings have material properties equal to, or better than, those described in this guidance document. The information requested can be used to determine if the new meta

27、llic thermal spray coated hip prostheses should be subject to postmarket surveillance requirements. If a new joint prosthesis requires postmarket surveillance, the requirements could be expected to be similar to those required of metallic plasma spray coated hip prostheses. CDRH要求有金属性热喷涂涂层的关节假体的制造商在

28、以后通过510（k）的新产品需包括来自本文件中所描述的试验方法的数据。CDRH将通过这些数据判断新的热喷涂涂层是否有等同于或优于本指南文件中所描述的那些（涂层）的材料特性。通过所要求的信息可确定新的金属热热喷涂涂层髋假体是否应受售后监测要求的支配。如果一个新的关节假体要求售后监测，这些要求可类似于对那些金属热热喷涂涂层髋假体的要求。Note:This guidance document represents the agencys current thinking on the testing results that will enable FDA to reconsider the req

29、uirement for postmarket surveillance of plasma sprayed hip prostheses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. If alternative approaches satisfy the requirements of the applicable statute, regulations, or both, the alternative appr

30、oaches may be used. 注：本指南文件代表了机构目前对于测试结果的看法，这些看法将会使FDA重新考虑对热喷涂涂层髋假体的售后监测的要求。但这些看法并不会产生或是赋予任何人任何权利并且也不会对FDA或公众产生约束。任一方法都可能会被使用只要这种方法能够满足适用的法规要求。Suggestions and recommendations presented in this document are not mandatory requirements, but reflect data and methodologies that CDRH believes could be acc

31、eptable. In this context, please note: 本文件中所提出的建议或论述并没有强制性规定，但反映的数据和方法， CDRH认为是可以接受的。在此背景下，请注意：This document suggests some important evaluation criteria, test procedures, and end points. There may be circumstances where alternative methods or additional information may be useful.本文推荐了一些重要的评估准则，试验程序和

32、最终观点。有可能的情况下，替代方法和额外信息将会是有用的。If the objectives of this document can be accomplished by means other than those stated herein, do not refrain from using those means.如果有其他方法比这里规定的方法更能达到本文件的目的，不限制使用这些方法。Some of the following recommended test methods may have to be modified, and/or additional methods may be needed, to address the individual properties of a particular product.下列的一些建议的测试方法和/或其它方法可能须修改，以区别特殊产品的特性。As scientific knowledge changes and scientific techniques improve, CDRH may update this document. The basic objectives of the docum