DESIGN CONTROL GUIDANCEMEDICAL DEVICE MANUFACTURERS设计过程控制指导 为了 医疗器械制造商.pdf

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1、CenterforDevicesandRadiologicalHealthDESIGNCONTROLGUIDANCEFORMEDICALDEVICEMANUFACTURERSThisGuidancerelatestoFDA21CFR820.30andSub-clause4.4ofISO9001March11,1997FOREWORDToensurethatgoodqualityassurancepracticesareusedforthedesignofmedicaldevicesandthattheyareconsistentwithqual

2、itysystemrequirementsworldwide,theFoodandDrugAdministrationrevisedtheCurrentGoodManufacturingPractice(CGMP)requirementsbyincorporatingthemintotheQualitySystemRegulation,21CFRPart820.Animportantcomponentoftherevisionistheadditionofdesigncontrols.Becausedesigncontrolsmustapply

3、toawidevarietyofdevices,theregulationdoesnotprescribethepracticesthatmustbeused.Instead,itestablishesaframeworkthatmanufacturersmustusewhendevelopingandimplementingdesigncontrols.Theframeworkprovidesmanufacturerswiththeflexibilityneededtodevelopdesigncontrolsthatbothcomplywi

4、ththeregulationandaremostappropriatefortheirowndesignanddevelopmentprocesses.Thisguidanceisintendedtoassistmanufacturersinunderstandingtheintentoftheregulation.Designcontrolsarebaseduponqualityassuranceandengineeringprinciples.Thisguidancecomplementstheregulationbydescribing

5、itsintentfromatechnicalperspectiveusingpracticaltermsandexamples.DraftguidancewasmadepubliclyavailableinMarch,1996.Weappreciatethemanycomments,suggestionsforimprovement,andencouragementwereceivedfromindustry,interestedparties,andtheGlobalHarmonizationTaskForce(GHTF)StudyGrou

6、p3.Thecommentsweresystematicallyreviewed,andrevisionsmadeinresponsetothosecommentsandsuggestionsareincorporatedinthisversion.Asexperienceisgainedwiththeguidance,FDAwillconsidertheneedforadditionalrevisionswithinthenextsixtoeighteenmonths.TheCenterpublishestheresultsofitswork

7、inscientificjournalsandinitsowntechnicalreports.Throughthesereports,CDRHalsoprovidesassistancetoindustryandtothemedicalandhealthcareprofessionalcommunitiesincomplyingwiththelawsandregulationsmandatedbyCongress.ThesereportsaresoldbytheGovernmentPrintingOffice(GPO)andbytheNati

8、onalTechnicalInformationService(NTIS).Manyreports,includingthisguidancedocu