GHTF SG5 PostMarket Clinical FollowUp Studies英.docx

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GHTF SG5 PostMarket Clinical FollowUp Studies英.docx

GHTFSG5PostMarketClinicalFollowUpStudies英

GHTF/SG5/N4:

2010

FINALDOCUMENT

Title:

Post-MarketClinicalFollow-UpStudies

AuthoringGroup:

StudyGroup5

Endorsedby:

TheGlobalHarmonizationTaskForce

Date:

February18,2010

Dr.LarryKelly,GHTFChair

ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,whichiscomprisedofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.

Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.

CONTENTS

Preface3

1.Introduction4

2.Scope4

3.References5

4.Definitions6

5.CircumstancesWhereAPost-MarketClinicalFollow-UpStudyIsIndicated7

6.ElementsOfAPost-MarketClinicalFollow-UpStudy8

7.TheUseOfStudyInformation10

Preface

ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.

1.INTRODUCTION

WhileclinicalevidenceisanessentialelementofthepremarketconformityassessmentprocesstodemonstrateconformitytoEssentialPrinciples,itisimportanttorecognisethattheremaybelimitationsintheclinicaldataavailableinthepre-marketphase.Suchlimitationsmaybedueto,forexample,thedurationofpre-marketclinicalinvestigations,thenumberofsubjectsinvolvedinaninvestigation,therelativehomogeneityofsubjectsandinvestigatorsandthecontrolofvariablesinthesettingofaclinicalinvestigationversususeinthefullrangeofconditionsencounteredingeneralmedicalpractice.

ItisappropriatetoplaceaproductonthemarketonceconformitytotherelevantEssentialPrinciples,includingafavourablerisk/benefitratio,hasbeendemonstrated.Completecharacterizationofallrisksmaynotalwaysbepossibleorpracticableinthepre-marketphase.Therefore,theremaybequestionsregardingresidualrisksthatshouldbeansweredinthepostmarketphasethroughtheuseofoneormoresystematicpost-marketclinicalfollow-upstudies.Post-marketclinicalstudiesarenotintendedtoreplacethepre-marketdatanecessarytomakethedecisionastoapprovethedevice.

Post-marketclinicalfollow-upstudiesareoneofseveraloptionsavailableinapost-marketsurveillanceprogramme（seeGHTFSG2N47）andcontributetotheriskmanagementprocess.

2.SCOPE

Thisdocumentisintendedtoprovideguidanceonpost-marketclinicalfollow-upstudiesdevelopedspecificallyforissuesofresidualrisk（includingthosemandatedbyregulation）.However,theprinciplespresentedmaybeapplicabletopost-marketclinicalfollow-upstudiesconductedforotherpurposes.

Thisdocumentdoesnotimposenewregulatoryrequirementsbutisintendedtoprovideguidanceontheappropriateuseandconductofpostmarketclinicalfollow-upstudies.

Thisdocumentprovidesguidanceinrelationto:

i）thecircumstanceswhereapost-marketclinicalfollow-upstudyisindicated;

ii）thegeneralprinciplesofpost-marketclinicalfollow-upstudiesinvolvingmedicaldevices;and

iii）theuseofstudyinformation,including,forexample,toprovideinformationtoupdatelabelling.

Thisdocumentdoesnotapplytoinvitrodiagnosticdevices.

3.REFERENCES

GHTFFinalDocuments:

SG1/N41:

2005EssentialPrinciplesofSafety&PerformanceofMedicalDevices

SG1/N44:

2008TheRoleofStandardsintheAssessmentofMedicalDevices

SG2/N47:

2005ReviewofCurrentRequirementsonPost-MarketSurveillance

SG5/N1:

2007ClinicalEvidence–KeyDefinitionsandConcepts

SG5/N2:

2007ClinicalEvaluation

SG5/N3:

2010ClinicalInvestigations

GHTFProposedDocuments:

SG1（WD）N065RegistrationofManufacturersandOtherPartiesandListingofMedicalDevices

InternationalStandards:

ISO14155-1:

2003Clinicalinvestigationofmedicaldevicesforhumansubjects–Part1Generalrequirements

ISO14155-2:

2003Clinicalinvestigationofmedicaldevicesforhumansubjects–Part2Clinicalinvestigationplans

ISO14971:

2007Applicationofriskmanagementtomedicaldevices

Others:

AgencyforHealthcareResearchandQualityRegistriesforEvaluatingPatientOutcomes:

AUser’sGuide

4.DEFINITIONS

ClinicalData:

Safetyand/orperformanceinformationthataregeneratedfromtheclinicaluseofamedicaldevice.

ClinicalEvaluation:

Theassessmentandanalysisofclinicaldatapertainingtoamedicaldevicetoverifytheclinicalsafetyandperformanceofthedevicewhenusedasintendedbythemanufacturer.

ClinicalEvidence:

Theclinicaldataandtheclinicalevaluationreportpertainingtoamedicaldevice.

ClinicalInvestigation:

Anysystematicinvestigationorstudyinorononeormorehumansubjects,undertakentoassessthesafetyand/orperformanceofamedicaldevice.

DeviceRegistry:

Anorganizedsystemthatusesobservationalstudymethodstocollectdefinedclinicaldataundernormalconditionsofuserelatingtooneormoredevicestoevaluatespecifiedoutcomesforapopulationdefinedbyaparticulardisease,condition,orexposureandthatserves（a）predeterminedscientific,clinicalorpolicypurpose（s）.（AgencyforHealthcareResearchandQuality,“RegistriesforEvaluatingPatientOutcomes:

AUser’sGuide”,modified）

Note:

Theterm“deviceregistry”asusedhereshouldnotbeconfusedwiththeconceptofdeviceregistrationandlisting.（SeeGHTFSG1N065）

Post-marketclinicalfollow-upstudy:

Astudycarriedoutfollowingmarketingapprovalintendedtoanswerspecificquestionsrelatingtoclinicalsafetyorperformance（i.e.residualrisks）ofadevicewhenusedinaccordancewithitsapprovedlabelling.Thesemayexamineissuessuchaslong-termperformance,theappearanceofclinicalevents（suchasdelayedhypersensitivityreactionsorthrombosis）,eventsspecifictodefinedpatientpopulations,ortheperformanceofthedeviceinamorerepresentativepopulationofprovidersandpatients.

ResidualRisk:

Riskremainingafterriskcontrolmeasureshavebeentaken（ISO14971）（e.g.knownoremergingrisks,orpotentialrisksduetostatisticallimitations）.

5.CircumstancesWhereAPost-MarketClinicalFollow-UpStudyIsIndicated

Theneedforpost-marketclinicalfollow-upstudiesshouldbedeterminedfromtheidentificationofresidualrisksthatmayimpacttherisk/benefitratio.

Circumstancesthatmayresultintheneedforpost-marketclinicalfollow-upstudiesinclude,forexample:

∙innovation,e.g.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;

∙anewindicationorclaimhasbeenapproved;

∙significantchangestodevicedesignorlabelling;

∙higherriskclassification;

∙higherriskanatomicallocations;

∙severityofdisease/treatmentchallenges;

∙questionsofabilitytogeneraliseclinicalinvestigationresults;

∙unansweredquestionsoflong-termsafetyandperformance;

∙resultsofanypreviousclinicalinvestigationincludingadverseeventsidentifiedorfrompostmarketsurveillanceactivities;

∙identificationofpreviouslyunstudiedpopulations;

∙discrepancybetweenthepremarketfollow-uptimescalesandtheexpectedlifeoftheproduct;

∙risksidentifiedfromtheliteratureorotherdatasourcesforsimilarmarketeddevices;

∙sensitivityoftargetpopulation;

∙interactionwithothermedicalproductsortreatments;

∙training/learningcurveissues;

∙emergenceofnewinformationrelatingtosafetyorperformance;

Post-marketclinicalfollow-upstudiesmaynotberequiredincaseswherethemedium/long-termsafetyandclinicalperformancearealreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.

6.ElementsofAPost-MarketClinicalFollow-UpStudy

Postmarketclinicalfollow-upstudiesareperformedonadevicewithinitsintendeduse/purpose（s）accordingtotheinstructionsforuse.Itisimportanttonotethatpost-marketclinicalfollow-upstudiesmustbeconductedaccordingtoapplicablelawsandregulations,andshouldfollowappropriateguidanceandstandards.

Theelementsofapost-marketclinicalfollow-upstudyinclude:

∙（a）clearlystatedobjective（s）;

∙ascientificallysounddesignwithanappropriaterationaleandstatisticalanalysisplan;

∙astudyplan;and

∙implementationofthestudyaccordingtotheplan,ananalysisofthedataandappropriateconclusion（s）

Theobjective（s）ofpost-marketclinicalfollow-upstudies

Theobjective（s）ofthestudyshouldbestatedclearlyandshouldaddresstheresidualrisk（s）identifiedandbeformulatedtoaddressoneormorespecificquestionsrelatingtotheclinicalsafetyorperformanceofthedevice.Aformalhypothesisshouldbeclearlyexpressed.

Thedesignofpostmarketclinicalfollow-upstudies

Pos

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