Pharm-411-Medical-Devices-Overview-of-Device-Regulations制药411医疗器械设备法规概述.pptVIP

Pharm411MedicalDevicesOverviewofDeviceRegulationsTomHazletPharmaceuticalOutcomesResearchPolicyProgram13April20051

MenuRegulatoryStuff:definitions,history“Tomarket,tomarket…”anddeviceclassificationWheretolookforinformationQuestions–wheneverWiththankstoDavePettenski,USFDA,fromwhosematerialmuchofthistalkwaspoached.2

FDACenterforMedicalDevicesandRadiologicalHealth(CDRH)firmswhomanufacture,repackage,relabel,and/orimportmedicaldevicessoldintheUnitedStates.radiationemittingelectronicproducts(medicalandnon-medical)suchaslasers,x-raysystems,ultrasoundequipment,microwaveovensandcolor/cdrh3

FDADefinitionof“medicaldevice”(h)Thetermdevice…meansaninstrument,apparatus,implement,machine,contrivance,implant,invitroreagent,orothersimilarorrelatedarticle,includinganycomponent,part,oraccessory,whichis-(1)recognizedintheofficialNationalFormulary,ortheUnitedStatesPharmacopeia,oranysupplementtothem,(2)intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure,mitigation,treatment,orpreventionofdisease,inmanorotheranimals,or(3)intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals,andwhichdoesnotachieveitsprimaryintendedpurposesthroughchemicalactionwithinoronthebodyofmanorotheranimalsandwhichisnotdependentuponbeingmetabolizedfortheachievementofitsprimaryintendedpurposes.4

FDAHistory-MedicalDeviceAmendmentsofHEWsurvey:10years10,000injuries751fatalitiesFDAsurvey:858deathsIndependentsurvey36,000complicationsinoneyear5

FDAHistory-MedicalDeviceAmendmentsof1976DalkonShield,anIUD,marketedw/opropertesting:removalrateof26.4%aninfectionrateof5%25miscarriages,16deathsCardiacpacemakersdefectsnecessitated30recallsinvolving23,000unitsMay28,19766

FDAHistory-MedicalDeviceAmendmentsof1976Keyfeatu