DIGITALHEALTHFUNCTIONALITYINITIATIVESTOFOSTERINNOVATIONINOPHTHALMICDEVICES

RONALDSCHUCHARDCENTERFORDEVICESANDRADIOLOGICALHEALTH

OFFICEOFDEVICEEVALUATION

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TypesofDigitalHealthDevices

Softwareas aMedicaldevice“SaMD”

Softwarein aMedicaldevice

in

as

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• Manyophthalmicdevicesrelyheavilyondigitaltechnology• AIsoftwarediagnostics(CADx)andadvancedanalytics(CADe)

areemergingrapidlyinhealthcare• Greaterconnectivity(interoperability)ofdeviceshasleadto

new/greaterrisks• Softwaredevelopmentpracticesareevolvingrapidly• Changestodigitaltechnology

aremorefrequent(includingaftermarketclearance/approval)

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RapidlyEvolvingLandscape

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TheRapidlyEvolvingNatureofDigitalHealthisSparkingaParadigmShift

CurrentRegulatoryParadigm

Premarkettimelinesuitedforhardware basedproducts

Software developmenttimelines,softwaredevelopmentpractices+rapiditerations

Deterministicrisks,knownresponsibilities,physicalproducts

Evolvingissues:cybersecurity;distributedresponsibilities,non-physicalproducts

Potentialforsignificantly differentcontentwithinsubmissions

Stableprogramexperience:~3,500510(k)submissions/2200pre-submissions

DigitalHealthParadigmShift

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• Telemedicine(e.g.,teleophthalmology)systems– TelemedicinehealthcareispartofthepracticeofmedicineandnotregulatedbyFDA

– TelemedicineislikelytohaveMedicalDeviceDataSystems(MDDS)functionalitywhichtransfers,stores,ordisplaysmedicaldevicedatawithoutcontrollingoralteringthefunctionsorparametersofamedicaldevice

– 21st CenturyCuresremovedMDDSfunctionalityfromthedefinitionofamedicaldevice;Section3060(a)(o)(1)(D)–“productsfortransferring,storing,convertingformats,ordisplayingclinicallaboratorytestorotherdevicedataandresults,findingsbyahealthcareprofessionalwithrespecttosuchdataandresults,generalinformationaboutsuchfindings,andgeneralbackgroundinformationaboutsuchlaboratorytestorotherdevice,unlesssuchfunctionisintendedtointerpretoranalyzeclinicallaboratorytestorotherdevicedata,results,andfinding”

TelemedicineinOphthalmicHealthCare

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• Telemedicinesystems(continued)–MedicalDevicesusedinTelemedicineareregulatedbyFDA(someofthemareDigitalHealthDevices)–OphthalmicCameras– AtHomeVisionTesters(e.g.,VisualAcuity&Amsler Grid)

– TelemedicineandDigitalHealthDevicescanbeClassIorClassII510(k)exemptdevices– Perimeterswithdatabases– Group1LightSourceOphthalmicCamerasvrs Group2LightSourceOphthalmicCameras

TelemedicineinOphthalmicHealthCare

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21stCenturyCuresAct– CodifiesFDAPoliciesAmendedthedefinitionof“device”intheFood,DrugandCosmeticActtoexclude certainsoftwarefunctionsintended...

FDAPoliciesaffected/codified

AdministrativeFunctionality

(B)formaintainingorencouragingahealthylifestyle;

(C)toserveasaelectronicpatientrecords;

(D) fortransferring,storing,convertingformats,ordisplayingclinicallaboratorytestorotherdevicedataandresultsandcertainotherrelatedinformation;

(E) toproviderecommendationstohealthcareprofessionalsforclinicaldecisions,wheretheusercanindependentlyreviewthebasisoftherecommendation.

(A)foradministrativesupport;

FDAPolicyforLowriskgeneralwellnessproducts

HealthManagementfunctionality

PolicyforClinicalDecisionSupportSoftwareincludedin

HealthManagementfunctionality

MedicalDeviceDataSystem(MDDS)

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ClinicalDecisionsSupport– DraftGuidance

• DraftGuidance(12/17)thatidentifiesthetypesofclinicaldecisionsupport(CDS)softwarefunctionalitiesthat:– Donotmeetthedefinitionofadeviceasamendedby

the21st CenturyCuresAct– MaymeetthedefinitionofadevicebutforwhichFDA

doesnotintendtoenforcecompliancewithapplicablerequirementsoftheFD&CAct,including,butnotlimitedto,premarketclearanceandpremarketapprovalrequirements

– TheFDAintendstofocusitsregulatoryoversighton

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AdministrativeFunctionality*

HealthManagementFunctionality*

MedicalDeviceFunctionality*

NoAdditionalRegulatoryOversight

PrimarilyFDAOversight

PrimaryFocusofProposedHealthITFramework

• Healthinformationmanagement;

• Datacaptureandencounterdocumentation;

• Electronicaccesstoclinicalresults;

• Mostclinicaldecisionsupport;• Medicationmanagement;• Electroniccommunication(e.g.provider-patient,provider-provider,etc.);

• Providerorderentry;• Knowledgemanagement;• PatientIDandmatching.

• Admissions;• Billingandclaimsprocessing;• Practiceandinventorymanagement;

• Scheduling;• Generalpurposecommunications;

• Analysisofhistoricalclaimsdata;

• Determinationofhealthbenefiteligibility;

• Reportingcommunicablediseases;

• Reportingonquality.

• Computeraideddetectionsoftware;

• Remotedisplayornotificationofreal-timealarmsfrombedsidemonitors;

• RefractiveSurgerytreatmentplanningsoftware;

• HighIOPdetection.

*Examplesprovidedarenotintendedtobeanexhaustivelistoffunctionalities.

FDASIACategoriesofHealthIT

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HealthManagementFunctionality1• Clinicianordersets• Clinicianhealthrecordsaccess• Drugdosingcalculations;• Drugformularyguidelines;• Remindersforpreventativecare;• Accesstotreatmentguidelines;• Calculationofpredictionrules.

MedicalDeviceFunctionality2• Computeraideddetection(CADe)• Computeraideddiagnostic(CADx)• Refractiontreatmentplanning• Roboticsurgicalplanningandcontrol• Electrophysiologyanalyticalsoftware.

Toolsintendedtoenhance,inform,andinfluencehealthcaredecisions.

1 Ifaproductwithhealthmanagementfunctionalitymeetsthestatutorydefinitionofamedicaldevice,FDAdoesnotintendtofocusitsoversightonit.

2 CDSthathavemedicaldevicefunctionalityandpresenthigherriskswarrantFDA’scontinuedfocusandoversight.

FDASIAHealthITClinicalDecision Support

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HealthInformationTechnology(IT)• FederalAgencieswithuniqueresponsibilitiesintheHealthInformationTechnology:– FoodandDrugAdministration(FDA)– OfficeoftheNationalCoordinatorforHealthIT(ONC)– FederalCommunicationsCommission(FCC)

• FoodandDrugAdministrationSafetyInnovationAct(FDASIA)of2012– FDAtoworkwithFCCandONCtoproposeastrategyandmakerecommendationsonanappropriate,risk-basedregulatoryframeworkforhealthITthatpromotesinnovation,protectspatientsafety,andavoidsunnecessaryandduplicativeregulation

• FDASIAHealthITReport– ReleasedbyFDA,FCCandONCon4/3/2014– Outlinesrisk-basedstrategyandrecommendations

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FocusingonHigherRiskFunctionality

HigherRiskFunctionality

Intendtoassurepatientsafetywhileencouragingadvancesininnovativetechnologyandproductlife-cycle

• DeNovo• 510(k)• PMA

LowerRiskFunctionality

Maynotalwaysenforceregulatoryrequirements

Lowerrisksarenotlikelytoexceedthelimitsofexemption(§886.9)

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• PremarketAssessments:– Whatarethekeyfunctionsofthedevice?– Whataretheaspectsofthedevicethatarevulnerable?– Howarethekeyfunctionsimpactedbyavulnerability?– Whatprotectionsareinplace?

• MethodsofMitigatingRisks:– Safeguardsbuiltintothesoftware/hardware– Methodstolimittheintendedusers– Labellingprovidedforpatientuse– Trainingmodulesandtutorials

RiskAssessmentiskey

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GeneralWellness– BigPicture

• FinalguidancepublishedonJuly29,2016• TheFDAencouragesthedevelopmentofgeneralwellness

productssuchasfitnesstrackers,whichcanempowerindividualstotakeamoreactiveroleinmanagingtheirhealth.

• TheFDA’sFinalGuidanceonGeneralWellnesstakesahands-offapproachtotheregulationoflowriskgeneralwellnessproductsthatonlypromoteahealthylifestyleorthatpromoteawell-knownassociationbetweenahealthylifestyleandacertaindiseaseorcondition.

• TheFDAwillcontinuetofocusitsoversightonproductsthatareinvasive,implantedorposegreaterriskstopatients,eveniftheyareintendedforgeneralwellnesspurposes.

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MedicalDeviceData

Systems

Softwareasa

MedicalDevice

Wireless-

Cybersecurity

AdvancedAnalytics

Interoperability

MobileMedical

Applications

Cloud-Fog/Edge

ArtificialIntelligence

Implementconsistentregulatorystrategiesandpoliciesforophthalmicdigitalhealthtechnologies

Opthalmic DigitalHealthAreas

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MedicalMobileApps(MMA)

• FinalGuidanceissuedFeb9,2015• Focusesonlyontraditionallyregulatedfunctionality

• Providesuserswithsamelevelofassuranceofpatientsafety

• IdentifiesmobileapptypesthatFDAdoesnotintendtoenforcerequirements

• Clarifieswhatisnotadevice–(OutsideofFDA’sJurisdiction)

Mobileappsnotconsidered

“medicaldevices”

MMA

Lowerriskmobileappsthat

meetdevicedefinition

MobileMedicalApps

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MMA’sIntendedUse

Theintendeduseofamobileappdetermineswhetheritmeetsthedefinitionofadevice.Asstatedin21CFR801.4,intendedusemaybeshownbylabelingclaims,advertisingmaterials,ororalorwrittenstatementsbymanufacturersortheirrepresentatives

Ingeneral,ifamobileappisintendedforuseinperformingamedicaldevicefunction(i.e.fordiagnosisofdiseaseorotherconditions,orthecure,mitigation,treatment,orpreventionofdisease)itisamedicaldevice,regardless ofthemobileplatformonwhichitisrun

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MMAOphthalmicExamples• DiseaseProgression– AidsinDiagnosis/Therapy

– MMAVisualAcuityandAmsler Grid/HOQ– MMAEyeMovementMonitor/HLLGWN– Mobiledevicecameras– TabletVisualFunctionAssessment

• TherapyMMAs– DichopticTreatmentofAmblyopia;Red/Green

GlassesorVirtualRealityGlasses– Wayfindingandobjectdetection/localizationas

assistivetechnologydevicesforvisuallyimpaired

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ConvergedFrameworkandPrinciplesforSaMD

Categorization Based on definition statement

SaMDdefinitionstatement:• CriticalityofContext• Significanceofrecommendation

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SaMD OphthalmicExamples

• DiagnosticSaMD– CADx forDiabeticRetinopathy

• OphthalmicImageManagementSystems- 892.205– PictureArchivingandCommunicationsSystem(PACS)/NFJ

• SaMD:ClinicalEvaluationGuidance– 12/17– ThisguidanceadoptstheinternationallyconvergedprinciplesagreeduponbytheIMDRF;https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf

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MachineLearning– DeepLearningSaMD

• AdvancedAnalytics:Adeviceorproductthatcanidentify,analyze,andusebigdataandlargecomplexdatasetsfromavarietyofsources.Theproductextractsnewandrelevantinformationorpatternstouseformedicalpurposesusingmachinelearningordeeplearning.

• ArtificialIntelligence:Adeviceorproductthatcanimitateintelligentbehaviorormimicshumanlearningandreasoning.Artificialintelligenceutilizesmachinelearning,neuralnetworks(deeplearning),andnaturallanguageprocessing.Sometermsusedtodescribeartificialintelligenceincludecomputer-aideddetection/diagnosis,statisticallearningorsmartalgorithms.

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MedicalDeviceInteroperabilityistheabilityoftwoormoreproducts ,technologiesorsystemstosafelyandeffectivelyexchangeanduseinformationthathasbeentransferredbetweendevices

9/2017FDAGuidance“DesignConsiderationsandPremarketSubmissionRecommendationsforInteroperableMedicalDevices

Interoperability

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InteroperabilityStandards

Canbeusedfordifferentlevelsofinteroperability

August2013– FDARecognized14standardsforinteroperability• Nomenclature• Medicaldevicecommunications• System/Softwarelifecycleprocess

• .

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Wireless

2013FinalGuidanceonAddressingRFWirelessTechnologyinMedicalDevices

• Selection/performanceofwirelesstechnology• QualityofService• WirelessCoexistence• WirelessDataIntegrity/Security• EMC• Labeling

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MedicalDeviceCybersecurity

October2014GuidanceContentofPremarketSubmissionsforManagementofCybersecurity

inMedicalDevices

• Philosophyofriskanalysisandmanagement• Considerappropriatesecuritycontrolssuch

as:o Limitaccesstotrustedusersonlyo Ensuretrustedcontento Usefailsafeandrecoveryfeatures

• Considerenvironmentofuse,typeandprobabilityoftheriskstowhichproductisexposed,andprobableriskstopatientsfromasecuritybreach

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12/2016– Postmarket ManagementofCybersecurityinMedicalDevicesGuidance

Cybersecurityriskmanagementprogramsshouldinclude:• Monitoringcybersecurityinformationsourcesforidentificationanddetectionofcybersecurityvulnerabilities

• Understanding,assessinganddetectingpresenceandimpactofavulnerability

• Establishingandcommunicatingprocessesforvulnerabilityintakeandhandling

• Clearlydefiningessentialclinicalperformancetodevelopmitigationsthatprotect,respondandrecoverfromthecybersecurityrisk

• Adoptingacoordinatedvulnerabilitydisclosurepolicyandpractice

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Cybersecurity

• Thehealthcareandpublichealth(HPH)sectorrepresentsasignificantandlargeattacksurface– Intrusionsandbreachesoccurthroughweaknessesinthesystemarchitecture

• Connectedmedicaldevices,likeallothercomputersystems,arevulnerabletothreats

• Whenmedicaldevicevulnerabilitiesarenotaddressedandremediated,theycanserveasaccesspointsforentryintohospital/healthcarefacilitynetworks– Mayleadtocompromiseofdataconfidentiality,integrity,andavailability

– Mayserveasasafetyissue

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FDA’sRolesinMedicalDeviceCybersecurity

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OngoingReviewofGuidanceDocuments

• Guidancedocumentsthatwilllikelybeupdated– GeneralWellness:PolicyforLowRiskDevices– MobileMedicalApplications– Off-The-ShelfSoftwareUseinMedicalDevices– MedicalDeviceDataSystems,MedicalImageStorageDevices,andMedicalImageTransferDevices

• Guidancedocumentthatwilllikelybewithdrawn– GuidancefortheSubmissionofPremarketNotificationsforMedicalImageManagementDevices

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FDAPre-Cert:AReimaginedApproach

Clinical TrialsOutcomes research

CommercialDistribution&Real-WorldUse

e.g.lower-risksoftware,certainmodifications

Real World Data

Collection

BasedonSaMDRisk+Pre-Certlevel

StreamlinedPremarketReview

FDAPre-Certlevel

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ConcepttoProgram:AnIterativeApproach

OrganizationalExcellence StreamlinedReview RealworldDataCollection

PublicmeetingJanuary2018

Programproofofconcept– Late2018

PilotStartSept2017

AreasofFocusDuringConceptDevelopment

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Conclusions

• OphthalmicDigitalHealthwillleadtomanynewinnovativedevicesthatwillprovidediagnosticandtherapeutichealthcare

• CDRHintendstofostertheRightCurefortheRightPatientattheRightTimethroughinnovativedigitalhealthproducts

• CDRHiscommittedtoevolvingRegulatoryParadigmsfordigitalhealthproductsinaflexibleprocess

• Continuedeffortsareneededtoevolveregulatorysciencefordigitalhealthfunctionality

• ThankyouforyourinterestinDigitalHealth