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1、CenterforDevicesandRadiologicalHealthPublicWorkshopBrain-ComputerInterfaceDevicesforPatientswithParalysisandAmputationNovember21,2014WelcomePleasesetcomputer,cellphone,andBlackberryonsilentmode,andanswercallsinthehallwayOpeningRemarksCarlosPeña,Ph.D.,M.S.VictorKrauthamer,P
2、h.D.CDRH,FDA•PatientsintheU.S.haveaccesstohigh-quality,safe,andeffectivemedicaldevicesofpublichealthimportancefirstintheworld.•TheU.S.istheworld’sleaderinregulatoryscience,CDRHmedicaldeviceinnovationandmanufacturing,andradiation-emittingproductsafety.Vision•U.S.post-market
3、surveillancequicklyidentifiespoorlyperformingdevices,accuratelycharacterizesreal-worldperformance,andfacilitatesdeviceapprovalorclearance.•DevicesarelegallymarketedintheU.S.andremainsafe,effective,andofhigh-quality.•Consumers,patients,theircaregivers,andprovidershaveaccess
4、tounderstandablescience-basedinformationaboutmedicaldevicesandusethisinformationtomakehealthcaredecisions.ExperienceinMovingNeurologicalandPhysicalMedicineDevicesFromBenchtoMarketNeurothrombectomyADHDMedicalDevicesMicrocathetersfortheDevicesforStrokeEpilepsyDBSNeurodiagnos
5、ticsDEKAProstheticArmForMigraineneurovasculatureIncreasingRegulatoryTransparencyNEWTargetedGuidanceforSponsors(+Developers&Innovators)•Pre-SubmissionGuidanceDocument•IDEsforEarlyFeasibilityClinicalStudiesGuidanceDocument•DesignConsiderationsforPivotalClinicalInvestigations
6、•ExpeditedAccessforPremarketApprovalMedicalDevicesIntendedforUnmetMedicalNeedforLifeThreateningorIrreversiblyDebilitatingDiseasesorConditionsAndPublicWorkshops!FDAPublicWorkshopsBrainComputerInterface(BCI)WorkshopForPatientswithParalysisandAmputationTodayNovember21,2014FDA
7、WhiteOakCampusSilverSpring,MarylandMeetingPurpose-SupportdevelopmentofdraftguidanceforBCIdevices***September30PostingofFDADiscussionPaper***It’sAboutthePatientsDivisionofBiomedicalPhysicsOurregulatoryresearchfocusesonthescienceofdevelopingnewtoolsapproachestoassessthesafet
8、y,efficacy,quality,andperformanceofallFDAregulatedproducts.•Biophysics»Neuroscience,Elect
