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1、Pharm411MedicalDevicesOverviewofDeviceRegulationsTomHazletPharmaceuticalOutcomesResearch&PolicyProgram13April20051MenuRegulatoryStuff:definitions,history“Tomarket,tomarket…”anddeviceclassificationWheretolookforinformationQuestions–wheneverWiththankstoDavePettenski,USFDA,fromwhosem
2、aterialmuchofthistalkwaspoached.2FDACenterforMedicalDevicesandRadiologicalHealth(CDRH)firmswhomanufacture,repackage,relabel,and/orimportmedicaldevicessoldintheUnitedStates.radiationemittingelectronicproducts(medicalandnon-medical)suchaslasers,x-raysystems,ultrasoundequipment,micro
3、waveovensandcolortelevisions.www.fda.gov/cdrh3FDADefinitionof“medicaldevice”(h)Theterm''device''…meansaninstrument,apparatus,implement,machine,contrivance,implant,invitroreagent,orothersimilarorrelatedarticle,includinganycomponent,part,oraccessory,whichis-(1)recognizedintheofficia
4、lNationalFormulary,ortheUnitedStatesPharmacopeia,oranysupplementtothem,(2)intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure,mitigation,treatment,orpreventionofdisease,inmanorotheranimals,or(3)intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals,an
5、dwhichdoesnotachieveitsprimaryintendedpurposesthroughchemicalactionwithinoronthebodyofmanorotheranimalsandwhichisnotdependentuponbeingmetabolizedfortheachievementofitsprimaryintendedpurposes.4FDAHistory-MedicalDeviceAmendmentsof19761969HEWsurvey:10years10,000injuries&751fatalities
6、FDAsurvey:858deathsIndependentsurvey36,000complicationsinoneyear5FDAHistory-MedicalDeviceAmendmentsof1976DalkonShield,anIUD,marketedw/opropertesting:removalrateof26.4%aninfectionrateof5%25miscarriages,16deathsCardiacpacemakersdefectsnecessitated30recallsinvolving23,000unitsMay28,1
7、9766FDAHistory-MedicalDeviceAmendmentsof1976Keyfeaturesofthe1976AmendmentsClassificationforregulatorypurposesPre-marketapproval:implanted&lifesupportingdevicesInterstatecommerceispresumedinallcasesAuthoritytoissueGMP's,AccesstoindustryrecordsRegistrationandlist,Authoritytobandevic
8、es7FDAHistorySafeMedicalDevicesAc
