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1、[CodeofFederalRegulations][Title21,Volume8][RevisedasofApril1,2011][CITE:21CFR806]TITLE21--FOODANDDRUGSCHAPTERI--FOODANDDRUGADMINISTRATIONDEPARTMENTOFHEALTHANDHUMANSERVICESSUBCHAPTERH--MEDICALDEVICES PART806MEDICALDEVICES;REPORTSOFCORRECTIONSANDREMOVALS SubpartA--GeneralProvisionsSec.
2、806.1Scope.(a)Thispartimplementstheprovisionsofsection519(f)oftheFederalFood,Drug,andCosmeticAct(theact)requiringdevicemanufacturersandimporterstoreportpromptlytotheFoodandDrugAdministration(FDA)certainactionsconcerningdevicecorrectionsandremovals,andtomaintainrecordsofallcorrectionsa
3、ndremovalsregardlessofwhethersuchcorrectionsandremovalsarerequiredtobereportedtoFDA.这部分执行《联邦食品、药品和化妆品法案》（法）519(f)章节的条款，要求器械制造商和进口商向食品和药物管理局(FDA)迅速报告某些操作有关设备更正和清除，并保持记录的所有更正和清除无论这种更正和清除是否需要向FDA报告。(b)Thefollowingactionsareexemptfromthereportingrequirementsofthispart:(1)Actionstakenbydev
4、icemanufacturersorimporterstoimprovetheperformanceorqualityofadevicebutthatdonotreducearisktohealthposedbythedeviceorremedyaviolationoftheactcausedbythedevice.(2)Marketwithdrawalsasdefinedin806.2(h).(3)Routineservicingasdefinedin806.2(k).(4)Stockrecoveriesasdefinedin806.2(l).[62FR2719
5、1,May19,1997,asamendedat63FR42232,Aug.7,1998]Sec.806.2Definitions.Asusedinthispart:(a)ActmeanstheFederalFood,Drug,andCosmeticAct.(b)AgencyorFDAmeanstheFoodandDrugAdministration.(c)Consigneemeansanypersonorfirmthathasreceived,purchased,orusedadevicesubjecttocorrectionorremoval.(d)Corre
6、ctionmeanstherepair,modification,adjustment,relabeling,destruction,orinspection(includingpatientmonitoring)ofadevicewithoutitsphysicalremovalfromitspointofusetosomeotherlocation.(e)Correctionorremovalreportnumbermeansthenumberthatuniquelyidentifieseachreportsubmitted.(f)Importermeans,
7、forthepurposesofthispart,anypersonwhoimportsadeviceintotheUnitedStates.(g)Manufacturermeansanypersonwhomanufactures,prepares,propagates,compounds,assembles,orprocessesadevicebychemical,physical,biological,orotherprocedures.Thetermincludesanypersonwho:(1)Repackagesorotherwisechangesthe
8、conta
