Medical Device Law医疗器械法规

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1、MedicalDeviceLawFDAFDARegulatedDevicesFromtheBeginningHubbardElectrometerCasesMagneticHealingCasesOriginalLawRequiredProofofHarmPost-Market,notPre-MarketCouldTietheFDAUpinCourtforYearsSafety,NotEfficacyNoRegulationofEfficacySafetyOnlyAsRegardsDirectHazardNoConsiderationofDangerofImprop

2、erTreatmentCongressionalHearingsEarly1970sPost-WWIIExpansionofTechnologyNecessaryForICUandSpecialtySurgeryAnIntegralPartofModernMedicineHighRiskDevicesPacemakersSubjecttoCatastrophicFailureAlsoBriberyIssuesAnesthesiaMachinesMarginallyCompetentPersonnelTheO-RingCongressDecidestoRegulate

3、DevicesMDAof1976MedicalDeviceAmendmentsof1976ShiftedfromPost-MarkettoPre-MarketPMALikeDrugsEstablishedRiskClassesClassI-LowRiskClassII-ModerateRiskClassIII-HighRiskExistingDevicesGrand-fatheredinpre-existingDevices510(k)“Substantiallyequivalent”toapre-1976DeviceOnlygetsGMPReviewFDAWasT

4、oEvaluateExistingDevicesNoMoneyNoPoliticalSupport360k(a)Exceptasprovidedinsubsection(b)ofthissection,noStateorpoliticalsubdivisionofaStatemayestablishorcontinueineffectwithrespecttoadeviceintendedforhumanuseanyrequirement--(1)whichisdifferentfrom,orinadditionto,anyrequirementapplicabl

5、eunderthischaptertothedevice,and(2)whichrelatestothesafetyoreffectivenessofthedeviceortoanyothermatterincludedinarequirementapplicabletothedeviceunderthischapter.ExemptrequirementsUponapplicationofaStateorapoliticalsubdivisionthereof,theSecretarymay,byregulationpromulgatedafternoticea

6、ndopportunityforanoralhearing,exemptfromsubsection(a)ofthissection,undersuchconditionsasmaybeprescribedinsuchregulation,arequirementofsuchStateorpoliticalsubdivisionapplicabletoadeviceintendedforhumanuseif—ExemptionRequirementsContinued(1)therequirementismorestringentthanarequirementun

7、derthischapterwhichwouldbeapplicabletothedeviceifanexemptionwerenotineffectunderthissubsection;or(2)therequirement--(A)isrequiredbycompellinglocalconditions,and(B)compliancewiththerequirementwouldnotcausethedevicetobeinviolationofanyapplicablerequirementunderthischapter.ExemptionC