fda金属等离子喷涂涂层测试指南

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1、GuidanceforIndustryandforFDAReviewers/Staff[医疗器械]产业和FDA全体职员指南GuidanceforIndustryontheTestingofMetallicPlasmaSprayedCoatingsonOrthopedicImplantstoSupportReconsiderationofPostmarketSurveillanceRequirements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Documentissuedon:Februa

2、ry2,2000发行日期：2000.2.2ThisdocumentsupersedesDraftGuidancereleaseofGuidanceforIndustryontheTestingofMetallicPlasmaSprayedCoatingsonOrthopedicImplantstoSupportReconsiderationofPostmarketSurveillanceRequirements,datedFebruary22,1999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

3、的骨科植入物的金属等离子喷涂涂层测试指南的草案U.S.DepartmentOfHealthAndHumanServices美国健康与人类服务部门FoodandDrugAdministrationFDACenterforDevicesandRadiologicalHealth（CDRH）器械和放射性健康中心PostmarketSurveillanceStudiesBranch售后监测研究机构DivisionofPostmarketSurveillance售后监测司OfficeofSurveillanceandB

4、iometrics监测和生物学测定办公室Preface前言PublicCommentCommentsandsuggestionsmaybesubmittedatanytimeforAgencyconsiderationtoPostmarketSurveillanceStudiesBranch,HFZ-543,OfficeofSurveillanceandBiometrics,1350PiccardDrive,RockvilleMD20850.CommentsmaynotbeacteduponbytheAgen

5、cyuntilthedocumentisnextrevisedorupdated.ForquestionsregardingtheuseorinterpretationofthisguidancecontactDanielS.McGunagleat(301)594-0643ormailto:dsm@cdrh.fda.gov14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，1350PiccardDrive和RockvilleMD20850以供考虑。机构不会对

6、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DanielS.McGunagle电话(301)594-0643或mailto:dsm@cdrh.fda.govAdditionalCopiesWorldWideWeb/CDRHhomepageathttp://www.fda.gov/cdrh/postsurv/plasmaspry.pdf,orCDRHFactsonDemandat1-800-899-0381or301-827-0111,specifynumber946whenpromp

7、tedforthedocumentshelfnumber.额外备份世界网络/CDRH国内网页http://www.fda.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。Guidance1forIndustryontheTestingofMetallicPlasmaSprayedCoatingsonOrthopedicImplantstoSupportReconsiderationofPostmar

8、ketSurveillanceRequirements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1Thisguidancedocumentsupersedesanearlierdocumenttitled"DraftGuidanceforIndustryontheTestingofMetallicPlasmaSprayedCoatingsonOrthopedicImplants