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1、BROKERSASSOCIATIONSEMINARSPECIALPRODUCTREQUIREMENTSJanuary22,2009ChicagoDistrict/FDARyanGibson,InvestigatorHumanDrugsAnimalDrugsMedicalDevicesMedicalDevicesThatEmitRadiationNon-MedicalDevicesThatEmitRadiationDevices:Sunglasses/ReadingGlassesRegulationsBiol

2、ogicalProductsBiologicalNumbersHumanDrugsDLS–DrugListingNumberfromtheForeignManufacturerNDA–NewDrugApplicationfromtheU.S.FirmIND–InvestigationNewDrugANDA–AbbreviatedNewDrugApplicationhttp://www.fda.gov/ANIMALDRUGSNAD–NewAnimalDrugApplicationNumber–Numberissue

3、dbyFDA/CVMtoaU.S.Firm/SponsorANA–AbbreviatedNewAnimalDrugNumber–NumberissuedbyFDA/CVMtoaU.S.Firm/SponsorDLS–DrugListingNumberfromtheForeignManufacturerINA–InvestigationalNewAnimalDrughttp://www.fda.gov/MEDICALDEVICESDEV–RegistrationnumberforImporterLST–Medica

4、lDeviceListingNumberPMN–PremarketNotification(510(k)#)PMA–PremarketApproval(“P”#)IDE-InvestigationalDeviceExemptionhttp://www.fda.gov/MedicalDevicesThatEmitRadiationDEV–RegistrationNumberForImporterLST–MedicalDeviceListingNumberPMN–510(k)NumberACC–Accessionn

5、umber2877Form–4partstotheformA,B,C,DNon-MedicalDevicesThatEmitRadiationACC–Accessionnumberfrommanufacturer2877Form–RAA,RAB,RAC,RADMDL–ModelNumberDevicesSunglassesorReadingGlassesDEV–RegistrationnumberforImporterLST–MedicalDeviceListingNumberIRC–ImpactResist

6、anceLensCertificateRegulations(CFR)UsethiscodeplusthequalifiertoinformFDAthataproductisexempted.MostofFDA’sregulationsareinTitle21.BiologicalProductsBFL–BiologicalEstablishmentLicenseNumberBPL-BiologicProductNumberBiologicalLicenseNumbercanbeprovidedusingeit

7、herAofCBiologicNumbersBiologic510(k)BK960002UseDeviceAofCPMNBiologicPMABP000028UseDeviceAofCPMANDABN040083UseDrugAofCNDASusanCiani,InvestigatorCosmeticsLACF/AF:LowAcidCannedFoodsandAcidifiedFoodsIFE:ImportForExportCosmeticsIfitisadrug,itrequiresforeignDLS.Con

8、cernsaboutPermittedcolorsBSEMicrobiologicalcontentLOWACID/ACIDIFIEDFOODSFCE–FoodCanningEstablishmentNumberContainerDimensionsforjars,cansandpouches.SID–ScheduleIdentifierNumberLOWACID/ACI