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SUBCHAPTERH--MEDICALDEVICESPART820QUALITYSYSTEMREGULATIONSubpartA--GeneralProvisions§820.1-Scope.§820.3-Definitions.§820.5-Qualitysystem.SubpartB--QualitySystemRequirements§820.20-Managementresponsibility.§820.22-Qualityaudit.§820.25-Personnel.SubpartC--DesignControls§820.30-Designcontrols.SubpartD--DocumentControls§820.40-Documentcontrols.SubpartE--PurchasingControls§820.50-Purchasingcontrols.SubpartF--IdentificationandTraceability§820.60-Identification.§820.65-Traceability.SubpartG--ProductionandProcessControls§820.70-Productionandprocesscontrols.§820.72-Inspection,measuring,andtestequipment.§820.75-Processvalidation.SubpartH--AcceptanceActivities§820.80-Receiving,in-process,andfinisheddeviceacceptance.§820.86-Acceptancestatus.SubpartI--NonconformingProduct§820.90-Nonconformingproduct.SubpartJ--CorrectiveandPreventiveAction§820.100-Correctiveandpreventiveaction.SubpartK--LabelingandPackagingControl§820.120-Devicelabeling.§820.130-Devicepackaging.SubpartL--Handling,Storage,Distribution,andInstallation§820.140-Handling.§820.150-Storage.§820.160-Distribution.§820.170-Installation.SubpartM--Records§820.180-Generalrequirements.§820.181-Devicemasterrecord.§820.184-Devicehistoryrecord.§820.186-Qualitysystemrecord.§820.198-Complaintfiles.SubpartN--Servicing§820.200-Servicing.SubpartO--StatisticalTechniques§820.250-Statisticaltechniques.Authority:21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383;42U.S.C.216,262,263a,264.Source:61FR52654,Oct.7,1996,unlessotherwisenoted.SubpartA--GeneralProvisionsSec.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)Inthisregulationthetermwhereappropriateisusedseveraltimes.Whenarequirementisqualifiedbywhereappropriate,itisdeemedtobeappropriateunlessthemanufacturercandocumentjustificationotherwise.Arequirementisappropriateifnonimplementationcouldreasonablybeexpectedtoresultintheproductnotmeetingitsspecifiedrequirementsorthemanufacturernotbeingabletocarryoutanynecessarycorrectiveaction.(b)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,andthefacilitiesandcont