最新Medical-Device-Law医疗器械法规教学讲义ppt.ppt

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1、Medical-Device-Law医疗器械法规FDAFDARegulatedDevicesFromtheBeginningHubbardElectrometerCasesMagneticHealingCasesOriginalLawRequiredProofofHarmPost-Market,notPre-MarketCouldTietheFDAUpinCourtforYearsSafety,NotEfficacyNoRegulationofEfficacySafetyOnlyAsRegardsDirectHazardNoConsiderationofDangerof

2、ImproperTreatmentExistingDevicesGrand-fatheredinpre-existingDevices510(k)“Substantiallyequivalent”toapre-1976DeviceOnlygetsGMPReviewFDAWasToEvaluateExistingDevicesNoMoneyNoPoliticalSupport360k(a)Exceptasprovidedinsubsection(b)ofthissection,noStateorpoliticalsubdivisionofaStatemayestablis

3、horcontinueineffectwithrespecttoadeviceintendedforhumanuseanyrequirement--(1)whichisdifferentfrom,orinadditionto,anyrequirementapplicableunderthischaptertothedevice,and(2)whichrelatestothesafetyoreffectivenessofthedeviceortoanyothermatterincludedinarequirementapplicabletothedeviceunder

4、thischapter.ExemptrequirementsUponapplicationofaStateorapoliticalsubdivisionthereof,theSecretarymay,byregulationpromulgatedafternoticeandopportunityforanoralhearing,exemptfromsubsection(a)ofthissection,undersuchconditionsasmaybeprescribedinsuchregulation,arequirementofsuchStateorpolitica

5、lsubdivisionapplicabletoadeviceintendedforhumanuseif—ExemptionRequirementsContinued(1)therequirementismorestringentthanarequirementunderthischapterwhichwouldbeapplicabletothedeviceifanexemptionwerenotineffectunderthissubsection;or(2)therequirement--(A)isrequiredbycompellinglocalconditi

6、ons,and(B)compliancewiththerequirementwouldnotcausethedevicetobeinviolationofanyapplicablerequirementunderthischapter.ExemptionCasesStateConsumerFraudStateRegulationofProfessionsHearingAidsMAsetstandardsfordisclosureandmarketingofhearingaidsThesewerechallengedasadditionalrequirementsund

7、er360kCourtStruckthemMAwouldneedtoaskforanexemptionunderthestatutoryprocessCipollonev.LiggettGroupTobaccoLabelingAct(1967?)RequiredStandardLabelsSaidStateCouldImposeNoOtherLabelingRequirementsLawyersKnewThisWasPreemptionLanguageCourtFoundStateTortClaimsRelatedtoWarningsar