21CFR820 Quality System Regulation.docx

21CFR820 Quality System Regulation.docx

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21CFR820QualitySystemRegulation

TITLE21--FOODANDDRUGS

CHAPTERI--FOODANDDRUGADMINISTRATION

DEPARTMENTOFHEALTHANDHUMANSERVICES

SUBCHAPTERH--MEDICALDEVICES

PART820QUALITYSYSTEMREGULATION

SubpartA--GeneralProvisions

Sec.820.1Scope.

（a）Applicability.

（1）Currentgoodmanufacturingpractice（CGMP）requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthispartgovernthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservicingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeticAct（theact）.Thispartestablishesbasicrequirementsapplicabletomanufacturersoffinishedmedicaldevices.Ifamanufacturerengagesinonlysomeoperationssubjecttotherequirementsinthispart,andnotinothers,thatmanufacturerneedonlycomplywiththoserequirementsapplicabletotheoperationsinwhichitisengaged.WithrespecttoclassIdevices,designcontrolsapplyonlytothosedeviceslistedin820.30（a）

（2）.Thisregulationdoesnotapplytomanufacturersofcomponentsorpartsoffinisheddevices,butsuchmanufacturersareencouragedtouseappropriateprovisionsofthisregulationasguidance.Manufacturersofhumanbloodandbloodcomponentsarenotsubjecttothispart,butaresubjecttopart606ofthischapter.Manufacturersofhumancells,tissues,andcellularandtissue-basedproducts（HCT/Ps）,asdefinedin1271.3（d）ofthischapter,thataremedicaldevices（subjecttopremarketreviewornotification,orexemptfromnotification,underanapplicationsubmittedunderthedeviceprovisionsoftheactorunderabiologicalproductlicenseapplicationundersection351ofthePublicHealthServiceAct）aresubjecttothispartandarealsosubjecttothedonor-eligibilityproceduressetforthinpart1271subpartCofthischapterandapplicablecurrentgoodtissuepracticeproceduresinpart1271subpartDofthischapter.Intheeventofaconflictbetweenapplicableregulationsinpart1271andinotherpartsofthischapter,theregulationspecificallyapplicabletothedeviceinquestionshallsupersedethemoregeneral.

（2）Theprovisionsofthispartshallbeapplicabletoanyfinisheddeviceasdefinedinthispart,intendedforhumanuse,thatismanufactured,imported,orofferedforimportinanyStateorTerritoryoftheUnitedStates,theDistrictofColumbia,ortheCommonwealthofPuertoRico.

（3）Inthisregulationtheterm"whereappropriate"isusedseveraltimes.Whenarequirementisqualifiedby"whereappropriate,"itisdeemedtobe"appropriate"unlessthemanufacturercandocumentjustificationotherwise.Arequirementis"appropriate"ifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.

（b）scope.

Thequalitysystemregulationinthispartsupplementsregulationsinotherpartsofthischapterexceptwhereexplicitlystatedotherwise.Intheeventofaconflictbetweenapplicableregulationsinthispartandinotherpartsofthischapter,theregulationsspecificallyapplicabletothedeviceinquestionshallsupersedeanyothergenerallyapplicablerequirements.

（c）Authority.

Part820isestablishedandissuedunderauthorityofsections501,502,510,513,514,515,518,519,520,522,701,704,801,803oftheact（21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383）.Thefailuretocomplywithanyapplicableprovisioninthispartrendersadeviceadulteratedundersection501（h）oftheact.Suchadevice,aswellasanypersonresponsibleforthefailuretocomply,issubjecttoregulatoryaction.

（d）Foreignmanufacturers.IfamanufacturerwhooffersdevicesforimportintotheUnitedStatesrefusestopermitorallowthecompletionofaFoodandDrugAdministration（FDA）inspectionoftheforeignfacilityforthepurposeofdeterminingcompliancewiththispart,itshallappearforpurposesofsection801（a）oftheact,thatthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,orservicingofanydevicesproducedatsuchfacilitythatareofferedforimportintotheUnitedStatesdonotconformtotherequirementsofsection520（f）oftheactandthispartandthatthedevicesmanufacturedatthatfacilityareadulteratedundersection501（h）oftheact.

（e）Exemptionsorvariances.

（1）Anypersonwhowishestopetitionforanexemptionorvariancefromanydevicequalitysystemrequirementissubjecttotherequirementsofsection520（f）

（2）oftheact.Petitionsforanexemptionorvarianceshallbesubmittedaccordingtotheproceduressetforthin10.30ofthischapter,theFDA'sadministrativeprocedures.GuidanceisavailablefromtheFoodandDrugAdministration,CenterforDevicesandRadiologicalHealth,DivisionofSmallManufacturers,InternationalandConsumerAssistance,10903NewHampshireAve.,Bldg.66,rm.4613,SilverSpring,MD20993-0002,1-800-638-2041or301-796-7100,FAX:

301-847-8149.

（2）FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchvarianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthneedforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.

[61FR52654,Oct.7,1996,asamendedat65FR17136,Mar.31,2000;65FR66636,Nov.7,2000;69FR29829,May25,2005;72FR17399,Apr.9,2007;75FR20915,Apr.22,2010]

Sec.820.3Definitions.

（a）ActmeanstheFederalFood,Drug,andCosmeticAct,asamended（secs.201-903,52Stat.1040etseq.,asamended（21U.S.C.321-394））.Alldefinitionsinsection201oftheactshallapplytotheregulationsinthispart.

（b）Complaintmeansanywritten,electronic,ororalcommunicationthatallegesdeficienciesrelatedtotheidentity,quality,durability,reliability,safety,effectiveness,orperformanceofadeviceafteritisreleasedfordistribution.

（c）Componentmeansanyrawmaterial,substance,piece,part,software,firmware,labeling,orassemblywhichisintendedtobeincludedaspartofthefinished,packaged,andlabeleddevice.

（d）Controlnumbermeansanydistinctivesymbols,suchasadistinctivecombinationoflettersornumbers,orboth,fromwhichthehistoryofthemanufacturing,packaging,labeling,anddistributionofaunit,lot,orbatchoffinisheddevicescanbedetermined.

（e）Designhistoryfile（DHF）meansacompilationofrecordswhichdescribesthedesignhistoryofafinisheddevice.

（f）Designinputmeansthephysicalandperformancerequirementsofadevicethatareusedasabasisfordevicedesign.

（g）Designoutputmeanstheresultsofadesigneffortateachdesignphaseandattheendofthetotaldesigneffort.Thefinisheddesignoutputisthebasisforthedevicemasterrecord.Thetotalfinisheddesignoutputconsistsofthedevice,itspackagingandlabeling,andthedevicemasterrecord.

（h）Designreviewmeansadocumented,comprehensive,systematicexaminationofadesigntoevaluatetheadequacyofthedesignrequirements,toevaluatethecapabilityofthedesigntomeettheserequirements,andtoidentifyproblems.

（i）Devicehistoryrecord（DHR）meansacompilationofrecordscontainingtheproductionhistoryofafinisheddevice.

（j）Devicemasterrecord（DMR）meansacompilationofrecordscontainingtheproceduresandspecificationsforafinisheddevice.

（k）Establishmeansdefine,document（inwritingorelectronically）,andimplement.

（l）Finisheddevicemeansanydeviceoraccessorytoanydevicethatissuitableforuseorcapableoffunctioning,whetherornotitispackaged,labeled,orsterilized.

（m）Lotorbatchmeansoneormorecomponentsorfinisheddevicesthatconsistofasingletype,model,class,size,composition,orsoftwareversionthataremanufacturedunderessentiallythesameconditionsandthatareintendedtohaveuniformcharacteristicsandqualitywithinspecifiedlimits.

（n）Managementwithexecutiveresponsibilitymeansthosesenioremployeesofamanufacturerwhohavetheauthoritytoestablishormakechangestothemanufacturer'squalitypolicyandqualitysystem.

（o）Manufacturermeansanypersonwhodesigns,manufactures,fabricates,assembles,orprocessesafinisheddevice.Manufacturerincludesbutisnotlimitedtothosewhoperformthefunctionsofcontractsterilization,installation,relabeling,remanufacturing,repacking,orspecificationdevelopment,andinitialdistributorsofforeignentitiesperformingthesefunctions.

（p）Manufacturingmaterialmeansanymaterialorsubstanceusedinorusedtofacilitatethemanufacturingprocess,aconcomitantconstituent,orabyproductconstituentproducedduringthemanufacturingprocess,whichispresentinoronthefinisheddeviceasaresidueorimpuritynotbydesignorintentofthemanufacturer.

（q）Nonconformitymeansthenonfulfillmentofaspecifiedrequirement.

（r）Productmeanscomponents,manufacturingmaterials,in-processdevices,finisheddevices,andreturneddevices.

（s）Qualitymeansthetotalityoffeaturesandcharacteristicsthatbearontheabilityofadevicetosatisfyfitness-for-use,includingsafetyandperformance.

（t）Qualityauditmeansasystematic,independentexaminationofamanufacturer'squalitysystemthatisperformedatdefinedintervalsandatsufficientfrequencytodeterminewhetherbothqualitysystemactivitiesandtheresultsofsuchactivi