FOREWORD: AMESSAGEFROMTHECENTERDIRECTOR

Today,FDAsCenterforDevicesandRadiologicalHealth(CDRHortheCenter)isreleasingforpublic
commenttwopreliminaryreportsrecommendingconcretestepswecouldtaketoadvancethreekey
objectivesofabalancedpublichealthapproach:fosteringmedicaldeviceinnovation,enhancing
regulatorypredictability,andimprovingpatientsafety.
ThesereportsaddressissuesofgreatimportancetotheCenter,theindustryweregulate,andthepublic
weserve.Together,theyrepresentablueprintforsmartermedicaldeviceoversight,withthetools
CDRHneedstodriveinnovationandhelpbringthebesttechnologiestopatients.
CDRHsresponsibilityistwofold:toprotectandpromotethepublichealth.Weuseouroversightto
keeppatientsfromharm,andwefosterthedevelopmentofsafeandeffectivenewproducts.The
recommendationsintodaysreportsrepresentsignificantopportunitiestoincreaseoureffectivenessin
carryingoutbothpartsofourmission.Byincreasingthepredictability,reliability,andefficiencyofour
regulatorypathways,wecanhelpprovidebettertreatmentsanddiagnosticstopatientsmorequickly,
stimulateinvestmentinanddevelopmentofpromisingnewtechnologiestomeetcriticalpublichealth
needs,andincreasetheglobalmarketpositionofU.S.medicaldevices.
TheactionsproposedinthesereportswouldcomplementtwomajorstepsCDRHisalreadytaking,in
collaborationwithothersinthefederalgovernment,tofostermedicaldeviceinnovation.Wehave
establishedanewinteragencyCouncilonMedicalDeviceInnovation,whoseaimistoidentifyunmet
publichealthneedsandfacilitatethedevelopmentorredesignofdevicestoaddressthoseneeds.
1
In
addition,FDArecentlysignedaninformationsharingMemorandumofUnderstandingwiththeCenters
forMedicareandMedicaidServices(CMS),whichwillallowustobettercoordinatetheworkofourtwo
agencies.
2
Theseeffortshavethepotentialtodramaticallystreamlinetheprocessofbringingnewsafe
andeffectivemedicaltechnologiestopatients.
ThereportsweredevelopedbytwointernalcommitteesIestablishedinSeptember2009:the510(k)
WorkingGroupandtheTaskForceontheUtilizationofScienceinRegulatoryDecisionMaking.I
convenedthesegroupstoaddresscriticalchallengesfacingtheCenterandourexternalconstituencies.
Thepremarketnotification(510(k))medicaldevicereviewprogramisintendedtomeettwoimportant
goals:makingavailabletoconsumersdevicesthataresafeandeffective,andfosteringinnovationinthe
medicaldeviceindustry.Inrecentyears,however,concernshavebeenraisedbothwithinandoutside
ofFDAaboutwhetherthecurrent510(k)programoptimallyachievesthesegoals.Somehaveargued
thatthe510(k)processallowsdevicestoenterthemarketwithoutsufficientevidenceofsafetyand
effectiveness.Othershavearguedthatalackofpredictability,consistency,andtransparencyinthe
processishinderingdevicedevelopment.Ichargedthe510(k)WorkingGrouptoevaluatethe510(k)
programandexploreactionsCDRHcouldtaketoenhanceour510(k)decisionmaking.
1
SeeIdentifyingUnmetPublicHealthNeedsandFacilitatingInnovationinMedicalDeviceDevelopment;NoticeofPublic
Workshop;RequestforComments,75FederalRegister101(26May2010),pp.2956029561.Availableat
http://edocket.access.gpo.gov/2010/201012588.htm.
2
SeeMemorandumofUnderstandingBetweenUnitedStatesFoodandDrugAdministrationandCentersforMedicare&
MedicaidServices.Availableat
http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm217585.ht
m.
CDRHPreliminaryInternalEvaluations Page1

Onefactorthatcomplicatesoursciencebaseddecisionmaking,inthe510(k)contextandmorebroadly,
isthatweoperatewithinaneverchangingscientificlandscape.Asnewscientificinformationemerges
abouttherisksandbenefitsofagivendevicetype,wemustbepreparedtomodifyourtreatmentof
thatdevicetypeaccordingly.Atthesametime,tofacilitateinnovation,weseektomaintain
predictabilityinourregulatorypathways.IchargedtheTaskForceontheUtilizationofSciencein
RegulatoryDecisionMakingtoassessthewayCDRHusesscienceinourdecisionmakingandidentify
stepswecouldtaketostrikeabetterbalancebetweenthesetwocriticalaims.
Thesearechallengingissues,andthewayweaddressthemhasthepotentialtosignificantlyimpact
medicaldevicedevelopment,thecompetitivenessoftheAmericaneconomy,and,mostfundamentally,
thehealthandwellbeingofthepublic.Wehaveheardarangeofperspectivesonthesetopicsatpublic
meetingsandtownhallsoverthepastseveralmonths.Whiletherehasnotalwaysbeenagreementon
thebestapproachforCDRHtotakemovingforward,thereiswidespreadrecognitionthatthereis
significantroomforimprovementinthewayweoperate.
ThepreliminaryreportswearereleasingtodayreflecttheinputofmanywithinandoutsideofCDRH.
Theycoverasubstantialamountofmaterialincarefuldetailatestamenttothethoughtfuland
thoroughassessmenteachcommitteehasundertakenoverthepastseveralmonths.Together,these
reportsproposeseveralactionstofostermedicaldeviceinnovation,enhanceregulatorypredictability,
andimprovepatientsafety.Iwouldliketohighlight10recommendationsinparticular.
I. FosteringMedicalDeviceInnovation
1. Streamlinethepremarketpathwayforlowerrisknoveldevices.
TheprocessforEvaluationofAutomaticClassIIIDesignation(alsoknownasthedenovo
classificationprocess)ismeanttoserveasaregulatorypathwayfornoveldevicesthatcannot
beclearedthroughthe510(k)processbecausetheylackaclearpredicate,butwhoserisksdo
notwarrantapremarketapproval(PMA)levelofreview.Ascurrentlyimplemented,thede
novoclassificationprocesstendstobeassociatedwithlengthyreviewtimeframesand
nontransparentdatarequirements,makingitanimpracticalpathtomarketformanydevice
developers.The510(k)WorkingGrouprecommendsthatCDRHmakemajorreformsinour
implementationofthedenovoprocess,includingstepstostreamlinetheprocessandclarifythe
Centersevidentiaryexpectationsfordenovorequests.
2. EnhancesciencebasedprofessionaldevelopmentforCDRHstaff.
Toaccommodatethedevelopmentofnoveltechnologies,withinthe510(k)contextandbeyond,
CDRHmustbeabletoreadilytapintorelevantscientificexpertiseinthecourseofourdecision
making.Boththe510(k)WorkingGroupandtheTaskForceontheUtilizationofSciencein
RegulatoryDecisionMakingrecommendthatCDRHenhancetraining,professional
development,andknowledgesharingamongCenterstaff,toassurethatappropriatescientific
expertiseandregulatoryexperiencearebroughttobearindecisionmaking.Bothgroups
recommendthattheseeffortsincludeprovidinggreateropportunitiesforstafftostayabreastof
recentscientificdevelopmentsandcurrentclinicalpractice.
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3. Establishanetworkofexternalexpertstobetterinformthereviewofcuttingedgetechnologies.
BecauseitisnotfeasibleforCDRHexpertstobeuptodateonallscientificdevelopments,
particularlyinnewlyemergingfields,itissometimesnecessaryforustosupplementourin
houseexpertisewiththatofexternalparties.TheTaskForceontheUtilizationofSciencein
RegulatoryDecisionMakingrecommendsthattheCentercontinueongoingefforts,inkeeping
withtheCentersFY2010StrategicPriorities,todevelopanetworkofexternalexpertsusing
webbasedsocialmediatechnology.SuchanetworkwouldallowCenterstafftomore
efficientlyandeffectivelyleverageoutsideknowledgeinordertoanswerimportantscientific
questions,butwouldnotserveinanadvisorycapacity.
II. EnhancingRegulatoryPredictability
4. Increasethepredictabilityof510(k)dataneedsbyestablishinganewclassIIb.
Withinthe510(k)context,mostinstanceswhereconcernshavebeenraisedbyindustryand
Centerstaffgenerallyhaveinvolvedthesmallsubsetofdevicesforwhichstaffrequestedclinical
informationmidwaythroughareviewbutwherethesubmitterhadnoadvancenoticethatsuch
informationwouldbeneededaspartofits510(k),leadingtoavoidabledelays.The510(k)
WorkingGroupthereforerecommendsthatCDRHdevelopguidancetodefine,atleastasa
heuristic,asubsetofclassIIdevicescalledclassIIbdevices,forwhichclinicalormanufacturing
informationwouldtypicallybenecessarytosupportasubstantialequivalencedetermination.
ThedevelopmentofaclassIIbguidancedocumentwouldhelpclarify,upfront,what
informationsubmittersshouldincludeintheir510(k)s,sothattheycanplanaccordingly.Inso
doing,itwouldhelpourreviewstaffobtain,inamoreefficientandpredictablemanner,the
typeandlevelofevidencetheyneedtomakereliable,wellsupporteddecisions.
5. CreateanewNoticetoIndustrytooltomorerapidlycommunicatechangesinpremarket
expectations.
Withrespectto510(k)reviewandalsomorebroadly,weasaCentermayneedtomodifyour
premarketevidentiaryexpectationsforcertaintypesofdevicesovertime,asscienceevolves
andnewinformationemergesabouttherisksandbenefitsofagivendevicetype.Under
currentlaw,ourtraditionalguidancedevelopmentprocesscanbecumbersome,andithasnot
allowedustocommunicatesuchchangesinarapidmanner.Instead,manufacturerstypically
learnofthesechangesthroughindividualengagementwiththeCenter,oftennotuntilafter
theyhavepreparedtheirpremarketsubmissions.TheTaskForceontheUtilizationofSciencein
RegulatoryDecisionMakingthereforerecommendsthatCDRHbegintousestandardized
NoticetoIndustryletterstoquicklycommunicatetoanaffectedsectorofindustrywhenwe
havechangedinourregulatoryexpectationswithrespecttoaparticulargroupofdevices,the
generalnatureofthechange,andtherationaleforthechange,generallyasaprecursortomore
detailedguidance.Theseletterswouldhelpprovidegreaterclaritytomanufacturers,ina
timeliermanner,aboutourevolvingexpectations.
6. Clarifythemeaningofkeytermsinthe510(k)substantialequivalencereviewstandardto
improvetheconsistency,transparency,andtimelinessofthereviewprocess.
Insufficientclaritywithrespecttocriticaltermsinthestatutorydefinitionofsubstantial
equivalencehas,insomecases,contributedtoinconsistencyinCDRHs510(k)decisionmaking,
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3
ObamaB,MemorandumfortheHeadsofExecutiveDepartmentsandAgencies(March9,2009).Availableat:
http://www.whitehouse.gov/the_press_office/memorandumfortheheadsofexecutivedepartmentsandagencies3909/.
internalandexternaldebates,anddelaysinreview.Asthe510(k)standardhasbeenappliedto
awiderrangeofdevicesovertime,includingincreasinglyvaried,complex,andpotentially
higherrisktechnologies,theneedforgreaterclarityhasbecomeevenmorepressing.The
510(k)WorkingGrouprecommendsthatCDRHmoreclearlydefinethesetermsinguidanceand
trainingforreviewstaffandindustry.
7. EstablishaCenterScienceCouncilasanewgovernancemodeltoassurequalityandconsistency
inCDRHssciencebaseddecisionmaking.
Regulatorypredictabilityalsodependsoneffectiveandexpertinternaloversight.Tobetter
assurequalityandconsistencyinCDRHssciencebaseddecisionmaking,boththe510(k)
WorkingGroupandtheTaskForceontheUtilizationofScienceinRegulatoryDecisionMaking
recommendthatCDRHestablishaCenterScienceCouncil,comprisedofexperiencedmanagers
andemployeesandunderthedirectionofthenewlycreatedDeputyCenterDirectorforScience
position.ConsistentwiththePresidentsmemorandumonscientificintegrity,
3
thisstanding
bodywouldberesponsibleforoverseeingsciencebaseddecisionmakingacrosstheCenter,
includingpremarketreview;periodicallyauditingdecisionsandassessingprogramperformance;
andactingasaresourceforstaffonscientificquestions,tosupportgreaterconsistencyin
decisionmakingandthetreatmentofcrosscuttingissues.
III. ImprovingPatientSafety
8. Requiretheupfrontsubmissionofmorecompletesafetyandeffectivenessinformationto
supportthereviewof510(k)devices.
Inordertosupportrobustandwellinformeddecisionmakingwithinthe510(k)process,the
510(k)WorkingGrouprecommendsthatCDRHconsiderrevisingexistingregulationstoexplicitly
require510(k)submitterstoprovideintheir510(k)sasummaryofallscientificinformation
knownorthatshouldbereasonablyknowntothesubmitterregardingthesafetyand/or
effectivenessofthedeviceunderreview.Currentregulationsdonotexpresslyrequire
submitterstoprovidesuchasummary.Asaresult,importantrelevantinformationmaynotbe
includedina510(k)uponinitialsubmission,evenwhenthatinformationisreadilyavailableto
thesubmitter.Requiringthistypeofsummarywouldallowreviewstafftomoreefficiently
makewellsupported510(k)decisionsthatconsiderallrelevantsafetyandeffectiveness
information.Includingsuchasummaryshouldnotpresentasignificantadditionalburdenfor
submitters,manyofwhomtypicallycollectthistypeofinformationintheirownproduct
developmentprocesses.
9. Createasearchableonlinepublicdatabasetoprovidemoredetailed,uptodatemedicaldevice
informationtoindustry,thehealthcarecommunity,andpatients.
BothcommitteesrecommendthatCDRHenhanceourwebbasedpublicresourcestoprovide
industry,practitioners,andpatientswithreadyaccesstomeaningful,uptodatedevice
informationthatwillhelpsupportinformedclinicaldecisionmakingandsafedeviceuse.The
510(k)WorkingGrouprecommendsthatCDRHmakemajorimprovementstoourcurrentonline
510(k)database,sothatitcanserveasasearchableonestopsourcefordetailedinformation
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CDRHPreliminaryInternalEvaluations Page5
aboutcleareddevices,includingphotographsanddesignschematics,summariesofFDAreview
decisions,anduptodatedevicelabeling.Suchadatabasewouldallowprospective510(k)
submitterstomorereadilyidentifyappropriatepredicatedevicesandwouldprovide
practitionersandpatientswithmorecomprehensiveandcurrentinformationtosupportthe
safeuseofcleareddevices.Similarly,theTaskForceontheUtilizationofScienceinRegulatory
DecisionMakingrecommendsthatCDRHcontinuetobuilduponourexistingTransparency
websitetoprovideexternalpartieswithmoreinformationaboutourregulatorydecisionsand
thesciencethatgroundsthosedecisions,acrossthetotalproductlifecycle.
10. ClarifyCDRHs510(k)rescissionauthorityandthecircumstancesunderwhichadeviceshouldnot
beusedasapredicate.
ConcernshavebeenraisedthatcurrentFDAregulationsandpracticemayallowforsometypes
ofpredicatecomparisonsthatareinsufficienttoconsistentlyprovidereasonableassurancethat
adeviceunderreview,subjecttogeneralandapplicablespecialcontrols,issafeandeffective
foritsintendeduse.The510(k)WorkingGrouprecommendsthatCDRHexplorethe
developmentofguidancetoidentifysituationsinwhichadeviceshouldnotbeusedasa
predicate,suchaswhenthedevicehasbeenremovedfromthemarketbecauseofsafety
concerns.Inaddition,toclarifythecircumstancesunderwhichCDRHwouldexerciseour
authoritytorescinda510(k)clearancetoremoveanunsafedevicefromthemarketand
precludeitsuseasapredicate,the510(k)WorkingGrouprecommendsthatCDRHconsider
issuingarescissionregulation.
Thetwovolumesthatfollowcontainthefindingsandrecommendationsofbothcommitteesinfull.
VolumeIprovidesthereportofthe510(k)WorkingGroup.VolumeIIprovidesthereportoftheTask
ForceontheUtilizationofScienceinRegulatoryDecisionMaking.Wherethereportsoverlap,they
referenceoneanother.
Therecommendationscontainedinthesereportsarepreliminary.CDRHhasnotmadeanydecisionson
specificchangestopursue.Weinviteinterestedindividualstosubmitcommentsonthesereportsand
therecommendationstheypropose,includingthefeasibilityofimplementationandpotential
alternatives.Onceourassessmentofpublicinputandothernecessaryreviewsarecompleted,wewill
announcewhichimprovementsweintendtoimplement,aswellasprojectedtimelinesfor
implementation.
JeffreyShuren,M.D.,J.D.
Director
CenterforDevicesandRadiologicalHealth
August2010