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InvestigationalDeviceExemptionsUSFDADeviceClinicaltrialApproval,2,Overview,InvestigationalDeviceExemptions(IDE)Regulation21CFR812AppliestoallclinicalinvestigationsofdevicestodeterminesafetyandeffectivenessFDAoversightofconductofstudy,useofdevice,protectionofhumansubjectsFDAreviewdependsupondeterminationofSignificantRisk(SR)orNonsignificantRisk(NSR)DeviceDeterminationmadebysponsor,thenIRB;FDAoversight,3,WhatisanIDE?,IDEpermitsclinicalevaluationofaninvestigationaldevice(21CFRPart812)Investigationaldeviceshavenotbeenclearedformarketing,aretheobjectofaninvestigationAlsoincludeslegallymarketeddeviceswithspecificmodificationsornewintendedusesClinicalevaluationprovidessafetyandeffectivenessdatatosupportapprovaland/ormarketingclearanceClinicalstudiesmostoftenconductedinsupportofPMAsOnlyasmallnumberof510(k)srequireclinicaldata,4,PurposeofIDERegulations812.1(a),Toencourage,totheextentconsistentwiththeprotectionofpublichealthandsafetyandwithethicalstandards,thediscoveryanddevelopmentofusefuldevicesintendedforhumanuseTomaintainoptimumfreedomforscientificinvestigatorsintheirpursuitofthispurpose,5,SignificantRiskDevices,Definition21CFR812.3(m)Potentialforseriousrisktosubjectshealth,safetyorwelfare(lifethreatening,impairbodyfunction/structure,necessitatemedical/surgicalintervention)ImplantUsedtosupportorsustainhumanlifeSubstantiallyimportantindiagnosing,curingormitigatingdiseaseFullIDErequiredwithFDAandInstitutionalReviewBoard(IRB)approvalExamples:implantedcatheters,epidural/spinalneedles,trachealtubes,infusionpumps,6,NonsignificantRiskDevices,NosignificantrisktosubjectAbbreviatedIDErequirementsNoFDAapprovalorreviewofstudyIRBapproval:studyproposal,whyNSR,previousstudies,informedconsentMonitoring,recordsandreportsrequiredExamples:generalurologicalcatheters,oximeters,nasalstents,anestheticgasmasks,7,InstitutionalReviewBoards,IRBmustcomplywithregulationsoutlinedin21CFRParts56and812Inmakingapprovaldecisions,samecriteriaforapprovalofanyresearchinvolvinganFDA-regulatedproductshouldbeusedRisksandbenefitsofaninvestigationaldevicevs.alternativedevicesorproceduresshouldbeconsideredApprovaldecisionsdifferfromdeterminationofsignificantrisk,whichissolelybaseduponthesignificanceofharmthatmayresultfromuseofthedevice,8,IDE-ExemptedInvestigations21CFR812.2(c),PreamendmentdevicesSubstantiallyequivalentdevicesDiagnosticdevicesNoninvasiveDoesnotrequireinvasivesamplingthatpresentssignificantriskDoesnotintroduceenergyintosubjectIsnotusedfordiagnosiswithoutconfirmationConsumerpreferencetesting,9,IDEApplication21CFR812.20,Reportofpriorinvestigations-21CFR812.27Investigationalplan-21CFR812.25Descriptionofmethods/controls/facilitiesformanufacturing,processing,packingandstorageofdeviceSamplePIagreementIRBchairpersoncontactinformationLabelingInformedconsentformsandmaterials,10,FDAActionsonIDEApplications21CFR12.30,Sponsormaystartinvestigation30daysafterFDAreceivesapplication(unlessFDAnotifiesotherwise)oruponreceiptofFDAorderofIDEapprovalApprovalofanIDEsignifiesthat:IRB(andincasesofsignificantriskdevices,FDA)hasreviewedandapprovedthestudyapplication;Investigationaldevicesmaybelawfullyshippedforthepurposesofclinicalevaluationofthedevice,withoutcomplyingwithotherrequirementsoftheFFDC;andAllrequirementsunder21CFRPart812havebeenmet.,11,FDAActionsonIDEApplications21CFR812.30,Groundsfordisapproval:FailuretocomplywithregulatoryrequirementsFailuretorespondtoFDArequestforadditionalinformationRisktosubjectsoutweighsbenefits;investigationscientificallyunsound;thereisreasontobelievedeviceisineffectiveInformedconsentinadequateInadequacyofmethods,facilitiesorcontrolsformanufacture,processing,packingorstorageofdeviceInadequatemonitoringandreviewofinvestigation,12,SupplementalApplications21CFR812.35,Priorapprovalrequiredforchangesininvestigationalplanexcept:ChangeseffectedforemergencyuseToprotectthelifeorphysicalwell-beingofasubjectinanemergencyReportedwithin5workingdaysChangeseffectedwithnoticetoFDAwithin5daysDevelopmentalchangesChangestoclinicalprotocolChangessubmittedintheannualreportCertainminorchangesIRBapprovalofnewfacilities,13,SponsorResponsibilities21CFR812.42-.47,FDAorMadebysponsortoinvestigatororinvestigatorsinstitutionexclusiveofthecostsoftheclinicalstudyorotherclinicalstudies,16,InvestigatorRecords21CFR812.140(a),CorrespondenceSubjectrecordsCasehistoriesandmedicalrecordsInformedconsentRelevantobservationsincludingadversedeviceeffectsRecordofexposuretodeviceProtocolandsupportingdocumentationOtherrecordsrequiredbyFDAregulations,17,SponsorRecords21CFR812.140(b),SRDevicesCorrespondenceRecordsofshipmentanddispositionSignedinvestigatoragreementsRecordsforadversedeviceeffectsNSRDevicesName/intendeduseofdeviceWhydeviceisNSRInvestigatorandIRBcontactinformationGMPinformationRecordsforadversedeviceeffects,18,InvestigatorReports21CFR812.150(a),UnanticipatedadversedeviceeffectsWithdrawalofIRBapprovalProgressreportsDeviationsfrominvestigationalplanUsewithoutinformedconsentFinalreport,19,SponsorReports21CFR812.150(b),UnanticipatedadversedeviceeffectsWithdrawalofIRB/FDAapprovalCurrentinvestigatorlistProgressreportsRecallanddevicedispositionUsewithoutinformedconsentFinalreportSignificantriskdevicedeterminationfromIRB,20,FDAInspectionalAuthority,AnyestablishmentwheredevicesareheldRecordsinspection-allrecordsrelatingtoaninvestigationRecordsidentifyingsubjects-verificationofinformedconsent,completereports,21,InvestigationalDevices:Prohibitions,CannotpromoteontestmarketCannotcommercializebychargingmorethannecessarytorecovercosts21CFR812.20(b)(8):Ifdeviceistobesold,mustprovidetheamountchargedinIDEapplicationandexplainwhysaledoesnotconstitutecommercializationofthedeviceCannotundulyprolonginvestigationCannotrepresentassafeandeffective,22,WarningLetters,23,WarningLetters,
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