21CFR812(FDA)
InvestigationalDeviceExemptions(IDE)
3TypesofDeviceStudies
NOTE:Whenusingadevice
aspartofresearch,
Researchersmustcomplete
AppendixK.
Version08-23-11
SignificantRisk
(SR)
SRdevicesrequirefullcommittee
reviewuponinitialreviewandat
continuingreview(atleast
annually).
UseofanSRdevicerequiresan
InvestigationalDeviceExemption
(IDE)andmustfollowalloftheIDE
regulationsat21CFR812.
TheFDAisthefinalarbiterof
whetherdeviceisSR.The
Researchermayinclude
documentationfromtheFDAofthe
riskassessment.Whenthisoccurs,
theIRBdoesnotneedtomakea
formaldetermination.
TheIRBmustdocumenttheSR
assessmentinthemeetingminutes
uponinitialreview.
SRassessmentbasedsolelyon
seriousnessofharmthatmayresult
fromtheuseofthedeviceinan
investigation,notonthedevice
alone.
ReassessmentofSRmayoccur
basedonmodificationsthatinvolve
ariskorotherchangesthatmay
affectriskdetermination.
IRBfurtherconsidersifstudy
shouldbeapprovedornotasper
criteriaforIRBapprovaland
applicableUC/UCIpolicies.
EvidenceofIDEneededbeforeIRB
approvalmaybegranted(e.g.FDA
determinationletter,IDE#listed
onSponsorMasterProtocol).
SRExamples:
Surgicallasersforuseinmedical
specialties
Tissueadhesivesforneurosurgery,
gastroenterology,ophthalmology,
general&plasticsurgeryand
cardiology
Cardiacbypass&assistdevices
NonsignificantRisk
(NSR)
NSRdevicesrequirefullcommittee
reviewuponinitialreview.TheIRB
mustdocumenttheNSRassessmentin
themeetingminutesuponinitial
review.
UseofanNSRdeviceDOESNOTrequire
anInvestigationalDeviceExemption
(IDE).
TheFDAisthefinalarbiterofwhether
deviceisNSR.TheResearchermay
includedocumentationfromtheFDAof
theriskassessment.Whenthisoccurs,
theIRBdoesnotneedtomakeaformal
determination.
NSRassessmentbasedsolelyon
seriousnessofharmthatmayresult
fromtheuseofthedeviceinan
investigation,notonthedevicealone.
ReassessmentofNSRmayoccurbased
onmodificationsthatinvolveariskor
otherchangesthatmayaffectrisk
determination.
IfdeterminedNSR,futurereviewsmay
beexpeditedviacategory9ifcriteriais
met.Thisshouldbedocumentedinthe
minutesattimeofreview.Maybe
category1bif sponsorprovidedaFDANSR
determinationletteratinitialsubmission.
IRBfurtherconsidersifstudyshouldbe
approvedornotaspercriteriaforIRB
approvalandapplicableUC/UCI
policies.
ResearchersthatuseNSRdevicesas
partoftheirIRBapprovedresearch
studymustfollowABBREVIATED
requirementsper21CFR812.2(b).
NSRExamples:
Lowpowerlaserforpaintreatment
ExternallywornmonitorforinsulinRXN
Dentalfillingmaterialmadefrom
traditionalmaterials
Dailywearcontactlenses
Exempt
Mayqualifyforexpeditedreview,
category#1b.
Exempt=exemptfromIDE
requirements(21CFR812)-with
someexceptions.
7exemptioncategoriesin21CFR
812.2(C)
Thefirsttwocategoriesfor
exemptionpertaintodevicesthat
wereeithermanufacturedbefore
1976orsimilarproducts
manufacturedafter1976(referred
toasa510Kdevice).
A510Kdeviceismanufacturedafter
1976andisdeterminedas
substantiallyequivalenttoadevice
incommercialdistribution.
Includesdiagnosticdevicestudies
(e.g.invitrodiagnosticstudies)as
longassponsorcomplieswith21
CFR809.10(C).
Categories3(diagnosticdevicethat
meetsspecificcriteria)and4
(consumerpreferencetesting,
testingofamodificationor
combination)arethemost
commonlyappliedforexemptions.
Anexemptstudybeingconductedto
collectdatatosupporteithera
clinicalinvestigationormarketing
applicationmustcomplywith21
CFR50(protectionofhuman
subjects)andshouldcomplywith21
CFR56(IRB).
ExemptExamples:
Consumerpreferencetesting
Testingofadevicemodification
Testingof2ormoredevicesin
commercialdistributionifthe
testingdoesnotcollectsafetyand
efficacydataorputsubjectsatrisk