UpdateontheInternationalMedicalDevice

RegulatorsForum

MelissaTorres,ME,MSAssociateDirectorforInternationalAffairs

OfficeoftheCenterDirectorCenterforDevicesandRadiologicalHealth

melissa.torres@fda.hhs.gov

2

InternationalMedicalDeviceRegulatorsForum(IMDRF)

Accelerate International Regulatory

Convergence

• Forum established in 2011 to accelerate international medical device regulatory harmonization and convergence building on the work of the Global Harmonization Task Force (GHTF)

• Address common public health regulatory challenges to convergence due to the globalization of medical device production and the emergence of new technologies

• Accelerate innovation by clear and practical regulatory expectations

3

IMDRFMissionandStrategicPlan

MissionTostrategicallyaccelerateinternationalmedicaldeviceregulatoryconvergencetopromoteanefficientandeffectiveregulatorymodelformedicaldevicesthatisresponsivetoemergingchallengesinthesectorwhileprotectingandmaximizingpublichealthandsafety.

StrategicPlan• EnhancePost-MarketSurveillance• ImprovetheEffectivenessandEfficiencyofPre-MarketReview

4

IMDRFWorkingGroups

• ActiveWorkingGroups– Comprisedofregulatorsonlyorregulatorsandstakeholdersdependingonthetopic.– PatientRegistries– AdverseEventTerminology– GoodRegulatoryReviewPractices– UniqueDeviceIdentification(UDI)– RegulatedProductSubmission(RPS)– Standards– PatientSpecificDevices

• ClosedWorkingGroups– NationalCompetentAuthorityReport(NCAR)– SoftwareasaMedicalDevice(SaMD)– MedicalDeviceSingleAuditProgram(MDSAP)

5

PatientRegistries

GoalTodevelopsharedessentialprinciplesofinformaticsinfrastructureandbestepidemiologicandstatisticalanalyticmethodologiestoenhancethequality,speedandcost-efficienciesofregulatoryscienceformedicaldevices.

Benefits• Linkingrelevantdatasourcesandtoolstoaninternationalsystemof

registrieswouldaddvaluetomultiplestakeholdersbyassuringanalysisvalidity

• Providesdefinitionsandqualifiersthatdefinetheimpact,value,andsustainabilityofregistries

• Buildsuponthesuccessesinbuildingnationalregistriesandinternationalcollaborations

• Notallcountriesmaybeabletocontributeregistrydatatoeverydeviceevaluation;however,allcountrieswillbenefit

6

PatientRegistriesIMDRFDocuments

IMDRF/REGISTRYWG/N33FINAL:2016PrinciplesofInternationalSystemofRegistriesLinkedtoOtherDataSourcesandTools• Definesessentialprinciplesforlinkingelectronicpatient,deviceandoutcome

registriesand/orrelateddatarepositoriesoridentifierssuchasuniquedeviceidentifiers,includingtheprinciplesbehinddataaccess,security,informaticsformats,governanceandotherkeyareasrelatedtoglobalregulatoryapplicationsformedicaldeviceevaluation.

IMDRF/RegistryWG/N42FINAL:2017MethodologicalPrinciplesintheUseofInternationalMedicalDeviceRegistryData• Definesessentialprinciplesrelatedtooptimalmethodologiesfortheanalysis

ofheterogeneousdatasourcesappliedtomedicaldevicesafetysignaldetection,performance,andreliability.

CurrentWorkItem:• Developmentofaqualificationtoolforinternationalregistriestakinginto

considerationavarietyofregulatorydecisions.

7

RelationshipofIMDRFRegistryDocuments

8

CurrentWorkItem:ToolsforAssessingtheUsabilityofRegistriesin

SupportofRegulatoryDecision-Making

• Theregistryassessmenttoolmakesrecommendationswithregardtothesixregulatoryuses:– Primaryapproval– Expanded/Broadenedindication– Post-marketstudy– Post-marketsurveillance– ObjectivePerformanceCriteria/PerformanceGoals- OPCs/PGs– Devicetrackingandfieldsafetycorrectiveactions

9

AssessmentChecklistforRegulatoryUseELEMENTS REGULATORYUSE

PrimaryApproval BroadeningIndication

PostMarketStudy

PostmarketSurveillance

DevelopmentofOPC/PG

DeviceTrackingandFieldSafetyCorrectiveActions

DeviceIdentificationUnambiguousDeviceIdentification(preferablyinternationallyrecognizedUDIsystem)

needed needed needed needed needed

PatientIdentification

PatientIdentification uniqueneeded

limitedacceptable

limitedacceptable

uniqueneeded

Linkability(Registrywithotherdatasource)Deterministic XX X XProbabilistic (not

recommended)XX XX XX

TransparencyandGovernance

Governancestructureandprocesses XX XX XX X XX XLegalrequirementsfordatacollection/handling

XX XX XX X XX X

PolicyonCOI XX XX XX XX XX XXPolicyonaccesstodata XX XX XX XX XX XXReport;Keyelementsandfrequencyofreports

X X X X X

Websiteandweb-reporting X X X X X X

Essentialinformationavailableforverificationbyrelevantauthority(e.g.competentauthority,notifiedbody)

XX XX XX XX

InformationonPatientDataProtection(e.g.ifExemptfromconsent,Opt-out,Opt-in)

XX XX XX XX XX

QualityandMethodologyProcessesLeadingtoActionableData

ListofRelevantVariablesandUseofControlledVocabularies

XX XX XX XX X X

Useofnationally/internationallyharmonizedminimumdatamodel

X X X X X

RegistryManagementprocesses(e.g.coverage,completeness,dataqualitycontrolandassurance,etc.)

XX XX XX XX XX

Conductofanalysesacrossdifferenttypesofanalysisframeworks

NA NA NA XX XX

LegendXX- HighlyRecommendedX- Desirable

- OptionalNA- NotApplicable

11

Conclusion

HowcanyougetinvolvedinIMDRF?• Participateinworkinggroups• Reviewandprovidefeedbackondraftdocuments– “ToolsforAssessingtheUsabilityofRegistriesinSupportofRegulatoryDecisionMaking”• Publicconsultationfor2monthsclosingonDecember1• http://www.imdrf.org/consultations/cons-registries-n46-pd1-170817.asp

• AttendIMDRFstakeholdersessions– MeetingsinMarchandSeptember

12

ThankYou