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1、SUBCHAPTERH--MEDICALDEVICESPART820QUALITYSYSTEMREGULATIONSubpartA--GeneralProvisions§820.1-Scope.§820.3-Definitions.§820.5-Qualitysystem.SubpartB--QualitySystemRequirements§820.20-Managementresponsibility.§820.22-Qualityaudit.§820.25-Personnel.SubpartC--Desig
2、nControls§820.30-Designcontrols.SubpartD--DocumentControls§820.40-Documentcontrols.SubpartE--PurchasingControls§820.50-Purchasingcontrols.SubpartF--IdentificationandTraceability§820.60-Identification.§820.65-Traceability.SubpartG--ProductionandProcessControls
3、§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-
4、Nonconformingproduct.SubpartJ--CorrectiveandPreventiveAction§820.100-Correctiveandpreventiveaction.SubpartK--LabelingandPackagingControl§820.120-Devicelabeling.§820.130-Devicepackaging.SubpartL--Handling,Storage,Distribution,andInstallation§820.140-Handling.§
5、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.Subpa
6、rtO--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)Ap
7、plicability.(1)Currentgoodmanufacturingpractice(CGMP)requirementsaresetforthinthisqualitysystemregulation.Therequirementsinthispartgovernthemethodsusedin,andthefacilitiesandcontrolsusedfor,thedesign,manufacture,packaging,labeling,storage,installation,andservi
8、cingofallfinisheddevicesintendedforhumanuse.TherequirementsinthispartareintendedtoensurethatfinisheddeviceswillbesafeandeffectiveandotherwiseincompliancewiththeFederalFood,Drug,andCosmeti
