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1、OverviewofRegulatoryRequirements:MedicalDevicesHello.MynameisBillSutton,andIamDeputyDirectoroftheDivisionofIndustryandConsumerEducation(DICE) andFDA'sCenterforDevicesandRadiologicalHealth.WelcometoCDRHLearn,FDA'swebpageforindustryeducation.CDRHLearnisourlatestinnovativeeducation
2、altool.Itconsistsofaseriesoftrainingmodulesdescribingmanyaspectsofmedicaldeviceandradiologicalhealthregulation,coveringbothpre-marketandpost-marketissues.Thistoolisintendedtoprovidethemedicaldeviceandtheradiologicalhealthindustrywithaninformationresourcethatiscomprehensive,inter
3、active,andeasilyaccessible.ThismoduleisintendedtoprovideanoverviewoftheregulatoryrequirementsformedicaldevicesorwhatissometimesreferredtoasDevices101.TheUSFoodandDrugAdministration(FDA)isresponsibleforregulatingandsupervisingthesafetyoffoods,dietarysupplements,drugs,vaccine,biol
4、ogicalmedicalproducts,bloodproducts,medicaldevices,radiation-emittingproducts,veterinaryproducts,andcosmetics.WithinFDA,theCenterforDevicesandRadiologicalHealth(CDRH)isresponsibleforensuringthesafetyandeffectivenessofmedicaldevicesandeliminatingunnecessaryexposuretoradiation-emi
5、ttingproducts.Now,let'stakeacloserlookattheorganizationchartfortheCenterforDevicesandRadiologicalHealth.AtthetopoftheorganizationchartistheOfficeoftheCenterDirectorandincludestheCDRHOmbudsman,followedbysevenoffices.Eachofficeservesafunctionthatcollectivelyensuresthatallmedicalde
6、vicesplacedonthemarketintheUnitedStatesaredeemedreasonablysafeandeffectivethroughoutthetotalproductlifecycle.Let'sbeginbylookingattheOfficeofCompliance.Thisistheofficeresponsibleforensuringthatallmedicaldevices,onceplacedonthemarket,remainsafeandeffective.Thisistheofficethatrevi
7、ewstheestablishmentinspectionreportsandrecalls.Thenextoffice,theOfficeofCommunication,Education,andRadiationPrograms,istheofficethat'sresponsiblefortheeducationofthestaff,throughourStaffCollege.ThisiswhereourRadiationProgramisadministered.ThisiswheretheIndustryAssistant'sOfficei
8、slocated,aswellasthetelevisionstudiowhereI'mtap
