RAPs Exam with correct Answers
510(k) ii- iiAnswers ii-Premarket iinotification iisubmission iibased iion iimedical iidevice
iibeing iisubstantially iiequivalent iito iia iiproduct iialready iion iithe iimarket
Active iiImplantable iiMedical iiDevice ii(AIMD) ii- iiAnswers ii-An iiactive iidevice iithat iiis
iiintended iito iibe iiintroduced iiwholly iior iipartially, iiby iisurgical iior iimedical iiintervention,
iiinto iithe iibody iior iiintroduced iiinto iia iinatural iiorifice iiof iithe iibody iiby iimedical
iiintervention iiand iito iiremain iiin iiplace iiafter iithe iiprocedure
Active iiImplantable iiMedical iiDevices iiDirective ii(AIMDD) ii- iiAnswers ii-Council iiDirective
ii90/385/EEC iiof ii20 iiJune ii1990 iion iithe iiapproximation iiof iithe iilaws iiof iithe iiMember
iiStates iirelating iito iiactive iiimplantable iimedical iidevices. iiFirst iiEU iimedical iidevice
iilegislation, iiimplemented iiin ii1995, iiapplies iito iiactive iiimplantable iimedical iidevices.
iiThis iidirected, iialong iiwith iiMDD iiand iiIVDD, iiprovides iithe iilegislative iiframework iiwithin
iiwith iiMember iiState iiCompetent iiAuthorities iiand iiNotified iiBodies iiregulate iithe iiCE-
marking iiprocess iifor iiplacing iiand iimaintaining iidevices iion iithe iimarket iiwithin iithe iiEC.
Active iiMedical iiDevice ii(AMD) ii- iiAnswers ii-Any iimedical iidevice, iithe iioperation iiof
iiwhich iidepends iion iian iielectrical iior iiother iienergy iisource iiand iiacts iiby iiconverting
iithis iienergy.
Active iiTherapeutic iiDevice ii(ATD) ii- iiAnswers ii-Any iimedical iidevice, iiwhether iiused
iialong iior iiin iicombination iiwith iiother iimedical iidevices, iito iisupport, iimodify, iireplace iior
iirestore iibiological iifunctions iior iistructures iiwith iia iiview iito iitreatment iior iialleviation iiof
iian iiillness, iiinjury iior iihandicap.
Advisory iiCommittee iion iithe iiSafety iiof iiMedical iiDevices ii(ACSMD) ii- iiAnswers ii-
Advices iiand iimakes iirecommendations iito iithe iiMinister iifor iiHealth iiand iiTGA iion iithe
iisafety, iirisk iiassessment, iirisk iimanagement, iiand iiperformance iiof iimedical iidevices
iisupplied iiin iiAustralia
Australian iiRegulatory iiGuidelines iifor iiMedical iiDevices ii(ARGMD) ii- iiAnswers ii-
Consolidated iireference iidocument iidetailing iithe iiregulatory iirequirements iifor iimedical
iidevices iiin iiAustralia
Authorized iiRepresentative ii(AR) ii- iiAnswers ii-A iinatural iior iilegal iiperson iiestablished iiin
iithe iiEU, iiexplicitly iidesignated iiby iia iinon-European iimanufacturer, iiwho iiacts iion iithe
iimanufacturer's iibehalf iito iicarry iiout iicertain iitasks iirequired iiin iiapplicable iidirectives.
,Banned iiDevice ii- iiAnswers ii-A iidevice iithat iipresents iia iisubstantial iideception,
iiunreasonable iirisk iiof iiinjury iior iiillness, iior iiunreasonable iidirect iiand iisubstantial
iidanger iito iithe iipublic iihealth.
Blue iiBook ii- iiAnswers ii-FDA's iiOffice iiof iiDevice iiEvaluation iiguidance iimemoranda
iiregarding iiPMN ii[510(k)] iisubmissions, iiPMPs, iiPDPs, iidevice iiclassifications, iiand
iiIDEs
CE iiMark ii- iiAnswers ii-European iiConformity, iiConformite iiEuropeene, iimark.
iiMandatory iiEuropean iimark iifor iiproducts iifalling iiunder iione iiof iithe iinew iiapproach
iidirectives ii(including iimedical iidevices) iito iiindicate iiconformity iiwith iiessential iihealth
iiand iisafety iirequirements.
Center iifor iiDevices iiand iiRadiological iiHealth ii(CDRH) ii- iiAnswers ii-US iiFDA iicenter
iiresponsible iifor iiregulating iifirms iithat iimanufacture, iirepackage, iire-label iiand/or iiimport
iimedical iidevices iisold iiin iithe iiUS, iiand iiradiation-emitting iielectronic iiproducts ii(medical
iiand iinon-medical) iisuch iias iilasers, iix-ray iisystems, iimicrowave iiovens iiand iicolor
iitelevisions.
Changes iiBeing iiEffected ii(CBE) ii- iiAnswers ii-A iisupplement iisubmission iito iiFDA iifor iia
iichange iiin iia iidrug, iidevice, iiproduction iiprocess, iiquality iicontrols, iiequipment, iior
iifacilities iiwith iia iimoderate iipotential iito iiadversely iiaffect iithe iiproduct's iiidentity,
iistrength, iiquality, iipurity, iior iipotency. iiChange iican iibe iimade iiimmediately
Class iiI iiDevice ii- iiAnswers ii-Requires iigeneral iicontrols iito iiensure iisafety iiand
iieffectiveness
Class iiII iiDevice ii- iiAnswers ii-Requires iigeneral iiand iispecial iicontrols iito iiensure iisafety
iiand iieffectiveness. iiSpecial iicontrols iimay iiinclude iimandatory iiperformance iistandards,
iipatient iiregistries iifor iiimplantable iidevices iiand iipostmarket iisurveillance. iiRequires
ii510(k) iiunless iiexempted; iimay iirequire iiclinical iitrials. iiClass iiII iidevices iiare iidivided
iiinto iiIIa iiand iiIIb
Class iiIIa iiDevices ii- iiAnswers ii-Class iiIIa iiare iidevices iiinstalled iiin iithe iibody iiin iithe
iishort iiterm ii(usually ii60 iiminutes iito ii30 iidays). iiThese iidevices iitend iito iiexchange
iienergy iiwith iia iipatient iiin iia iitherapeutic iimanner iior iiare iiused iito iidiagnose iior iimonitor
iimedical iiconditions. iiThey iiare iigenerally iiinvasive iibut iionly iilimited iito iinatural iiorifices.
iiIf iithis iikind iiof iidevice iiis iiin iisome iiway iipotentially iihazardous iito iithe iipatient, iiit
iiautomatically iibecomes iiClass iiIIb.
Class iiIIb iiDevices ii- iiAnswers ii-Class iiIIb iiare iislightly iimore iicomplex iidevices iithan iiIIa
iidevices iiand iiare iioften iiinstalled iiwithin iithe iibody iifor iimore iithan ii30 iidays. iiClass iiIIb
iirefers iito iimost iisurgically iiinvasive iior iiactive iidevices iiwhich iiare iipartially iior iientirely
iiimplanted iiinto iithe iibody. iiThis iiclass iimay iialso iimodify iithe iicomposition iiof iibodily
iifluids.
, Class iiIII iiDevice ii- iiAnswers ii-Requires iigeneral iicontrols, iispecial iicontrols iiand iiPMA.
iiIncludes iidevices iithat iiare iilife-sustaining, iilife-supporting, iior iipose iipotential iirisk iito
iipatients. iiPMA iimay iirequire iiclinical iitrials.
Clearance ii- iiAnswers ii-Permission iito iimarket iia iidevice iithat iidemonstrates iisubstantial
iiequivalence iito iipre-amendment iidevice iior iianother iidevice iireviewed iiunder iisection
ii510(k) iiof iithe iiFD&C iiAct.
Combination iiProduct ii(CP) ii- iiAnswers ii-A iicombination iiproduct iiis iicomposed iiof iia
iidrug iiand iia iidevice; iia iibiological iiproduct iiand iia iidevice; iia iidrug iiand iia iibiological
iiproduct; iior iia iidrug, iidevice, iiand iia iibiological iiproduct. iiCPs iiare iifurther iidefined iiin ii21
iiCFR ii3.2(e).
Commercial iiDistribution ii- iiAnswers ii-Distribution iiof iia iihuman iidrug iior iimedical
iidevice, iiexcept iifor iiinvestigational iiuse iiand iiany iidistribution iiof iian iianimal iidrug iior
iianimal iifeed iibearing iior iicontaining iian iianimal iidrug iifor iinon-investigational iiuses, iibut
iithe iiterm iidoes iinot iiinclude iiinternal iior iiinterplant iitransfer iiof iia iidevice iior iibulk iidrug
iisubstance iibetween iiregistered iiestablishments iiwithin iithe iisame iiparent, iisubsidiary,
iiand/or iiaffiliate iicompany.
Communication iifrom iithe iiCommission iito iithe iiCouncil iiand iithe iiEuropean iiParliament
iion iiMedical iiDevices ii(COM ii2003 ii386 iiFinal) ii- iiAnswers ii-The iiCommission's iipolicy
iiconclusions iion iithe iifunctioning iiof iithe iimedical iidevice iidirectives, iibased iion iithe
iiissues iihighlighted iiin iithe iireport iiof iithe iiMedical iiDevice iiExpert iiGroup ii(MDEG).
Companion iiDiagnostic ii(CDx/CoDx) ii- iiAnswers ii-An iiin iivitro iidiagnostic iidevice iior
iiimaging iitool iithat iiprovides iiinformation iithat iiis iiessential iifor iithe iisafe iiand iieffective
iiuse iiof iia iicorresponding iitherapeutic iiproduct.
Complaint ii- iiAnswers ii-Any iiwritten, iielectronic, iior iioral iicommunication iialleging
iideficiencies iirelated iito iithe iiidentity, iiquality, iidurability, iireliability, iisafety,
iieffectiveness, iior iiperformance iiof iia iiproduct iiafter iirelease iifor iidistribution.
Computer iiSystem iiValidation ii(CSV) ii- iiAnswers ii-The iidocumented iiprocess iiof
iiassuring iithat iia iicomputer iisystem iidoes iiexactly iiwhat iiit iiis iidesigned iito iido iiin iia
iiconsistent iiand iireproducible iimanner.
Conflict iiof iiInterest ii(COI) ii- iiAnswers ii-Situation iiin iiwhich iithe iiconcerns iior iiaims iiof
iitwo iidifferent iiparties iiare iiincompatible
Conformity iiAssessment ii- iiAnswers ii-The iisystematic iiexamination iiof iievidence
iigenerated iiand iiprocedures iiundertaken iiby iithe iimanufacturer, iiunder iirequirements
iiestablished iiby iithe iiregulatory iiauthority, iito iidetermine iia iimedical iidevice iiis iisafe iiand
iiperforms iias iiintended iiby iithe iimanufacturer iiand, iitherefore, iiconforms iito iithe
iiEssential iiPrinciples iiof iiSafety iiand iiPerformance iifor iiMedical iiDevices
510(k) ii- iiAnswers ii-Premarket iinotification iisubmission iibased iion iimedical iidevice
iibeing iisubstantially iiequivalent iito iia iiproduct iialready iion iithe iimarket
Active iiImplantable iiMedical iiDevice ii(AIMD) ii- iiAnswers ii-An iiactive iidevice iithat iiis
iiintended iito iibe iiintroduced iiwholly iior iipartially, iiby iisurgical iior iimedical iiintervention,
iiinto iithe iibody iior iiintroduced iiinto iia iinatural iiorifice iiof iithe iibody iiby iimedical
iiintervention iiand iito iiremain iiin iiplace iiafter iithe iiprocedure
Active iiImplantable iiMedical iiDevices iiDirective ii(AIMDD) ii- iiAnswers ii-Council iiDirective
ii90/385/EEC iiof ii20 iiJune ii1990 iion iithe iiapproximation iiof iithe iilaws iiof iithe iiMember
iiStates iirelating iito iiactive iiimplantable iimedical iidevices. iiFirst iiEU iimedical iidevice
iilegislation, iiimplemented iiin ii1995, iiapplies iito iiactive iiimplantable iimedical iidevices.
iiThis iidirected, iialong iiwith iiMDD iiand iiIVDD, iiprovides iithe iilegislative iiframework iiwithin
iiwith iiMember iiState iiCompetent iiAuthorities iiand iiNotified iiBodies iiregulate iithe iiCE-
marking iiprocess iifor iiplacing iiand iimaintaining iidevices iion iithe iimarket iiwithin iithe iiEC.
Active iiMedical iiDevice ii(AMD) ii- iiAnswers ii-Any iimedical iidevice, iithe iioperation iiof
iiwhich iidepends iion iian iielectrical iior iiother iienergy iisource iiand iiacts iiby iiconverting
iithis iienergy.
Active iiTherapeutic iiDevice ii(ATD) ii- iiAnswers ii-Any iimedical iidevice, iiwhether iiused
iialong iior iiin iicombination iiwith iiother iimedical iidevices, iito iisupport, iimodify, iireplace iior
iirestore iibiological iifunctions iior iistructures iiwith iia iiview iito iitreatment iior iialleviation iiof
iian iiillness, iiinjury iior iihandicap.
Advisory iiCommittee iion iithe iiSafety iiof iiMedical iiDevices ii(ACSMD) ii- iiAnswers ii-
Advices iiand iimakes iirecommendations iito iithe iiMinister iifor iiHealth iiand iiTGA iion iithe
iisafety, iirisk iiassessment, iirisk iimanagement, iiand iiperformance iiof iimedical iidevices
iisupplied iiin iiAustralia
Australian iiRegulatory iiGuidelines iifor iiMedical iiDevices ii(ARGMD) ii- iiAnswers ii-
Consolidated iireference iidocument iidetailing iithe iiregulatory iirequirements iifor iimedical
iidevices iiin iiAustralia
Authorized iiRepresentative ii(AR) ii- iiAnswers ii-A iinatural iior iilegal iiperson iiestablished iiin
iithe iiEU, iiexplicitly iidesignated iiby iia iinon-European iimanufacturer, iiwho iiacts iion iithe
iimanufacturer's iibehalf iito iicarry iiout iicertain iitasks iirequired iiin iiapplicable iidirectives.
,Banned iiDevice ii- iiAnswers ii-A iidevice iithat iipresents iia iisubstantial iideception,
iiunreasonable iirisk iiof iiinjury iior iiillness, iior iiunreasonable iidirect iiand iisubstantial
iidanger iito iithe iipublic iihealth.
Blue iiBook ii- iiAnswers ii-FDA's iiOffice iiof iiDevice iiEvaluation iiguidance iimemoranda
iiregarding iiPMN ii[510(k)] iisubmissions, iiPMPs, iiPDPs, iidevice iiclassifications, iiand
iiIDEs
CE iiMark ii- iiAnswers ii-European iiConformity, iiConformite iiEuropeene, iimark.
iiMandatory iiEuropean iimark iifor iiproducts iifalling iiunder iione iiof iithe iinew iiapproach
iidirectives ii(including iimedical iidevices) iito iiindicate iiconformity iiwith iiessential iihealth
iiand iisafety iirequirements.
Center iifor iiDevices iiand iiRadiological iiHealth ii(CDRH) ii- iiAnswers ii-US iiFDA iicenter
iiresponsible iifor iiregulating iifirms iithat iimanufacture, iirepackage, iire-label iiand/or iiimport
iimedical iidevices iisold iiin iithe iiUS, iiand iiradiation-emitting iielectronic iiproducts ii(medical
iiand iinon-medical) iisuch iias iilasers, iix-ray iisystems, iimicrowave iiovens iiand iicolor
iitelevisions.
Changes iiBeing iiEffected ii(CBE) ii- iiAnswers ii-A iisupplement iisubmission iito iiFDA iifor iia
iichange iiin iia iidrug, iidevice, iiproduction iiprocess, iiquality iicontrols, iiequipment, iior
iifacilities iiwith iia iimoderate iipotential iito iiadversely iiaffect iithe iiproduct's iiidentity,
iistrength, iiquality, iipurity, iior iipotency. iiChange iican iibe iimade iiimmediately
Class iiI iiDevice ii- iiAnswers ii-Requires iigeneral iicontrols iito iiensure iisafety iiand
iieffectiveness
Class iiII iiDevice ii- iiAnswers ii-Requires iigeneral iiand iispecial iicontrols iito iiensure iisafety
iiand iieffectiveness. iiSpecial iicontrols iimay iiinclude iimandatory iiperformance iistandards,
iipatient iiregistries iifor iiimplantable iidevices iiand iipostmarket iisurveillance. iiRequires
ii510(k) iiunless iiexempted; iimay iirequire iiclinical iitrials. iiClass iiII iidevices iiare iidivided
iiinto iiIIa iiand iiIIb
Class iiIIa iiDevices ii- iiAnswers ii-Class iiIIa iiare iidevices iiinstalled iiin iithe iibody iiin iithe
iishort iiterm ii(usually ii60 iiminutes iito ii30 iidays). iiThese iidevices iitend iito iiexchange
iienergy iiwith iia iipatient iiin iia iitherapeutic iimanner iior iiare iiused iito iidiagnose iior iimonitor
iimedical iiconditions. iiThey iiare iigenerally iiinvasive iibut iionly iilimited iito iinatural iiorifices.
iiIf iithis iikind iiof iidevice iiis iiin iisome iiway iipotentially iihazardous iito iithe iipatient, iiit
iiautomatically iibecomes iiClass iiIIb.
Class iiIIb iiDevices ii- iiAnswers ii-Class iiIIb iiare iislightly iimore iicomplex iidevices iithan iiIIa
iidevices iiand iiare iioften iiinstalled iiwithin iithe iibody iifor iimore iithan ii30 iidays. iiClass iiIIb
iirefers iito iimost iisurgically iiinvasive iior iiactive iidevices iiwhich iiare iipartially iior iientirely
iiimplanted iiinto iithe iibody. iiThis iiclass iimay iialso iimodify iithe iicomposition iiof iibodily
iifluids.
, Class iiIII iiDevice ii- iiAnswers ii-Requires iigeneral iicontrols, iispecial iicontrols iiand iiPMA.
iiIncludes iidevices iithat iiare iilife-sustaining, iilife-supporting, iior iipose iipotential iirisk iito
iipatients. iiPMA iimay iirequire iiclinical iitrials.
Clearance ii- iiAnswers ii-Permission iito iimarket iia iidevice iithat iidemonstrates iisubstantial
iiequivalence iito iipre-amendment iidevice iior iianother iidevice iireviewed iiunder iisection
ii510(k) iiof iithe iiFD&C iiAct.
Combination iiProduct ii(CP) ii- iiAnswers ii-A iicombination iiproduct iiis iicomposed iiof iia
iidrug iiand iia iidevice; iia iibiological iiproduct iiand iia iidevice; iia iidrug iiand iia iibiological
iiproduct; iior iia iidrug, iidevice, iiand iia iibiological iiproduct. iiCPs iiare iifurther iidefined iiin ii21
iiCFR ii3.2(e).
Commercial iiDistribution ii- iiAnswers ii-Distribution iiof iia iihuman iidrug iior iimedical
iidevice, iiexcept iifor iiinvestigational iiuse iiand iiany iidistribution iiof iian iianimal iidrug iior
iianimal iifeed iibearing iior iicontaining iian iianimal iidrug iifor iinon-investigational iiuses, iibut
iithe iiterm iidoes iinot iiinclude iiinternal iior iiinterplant iitransfer iiof iia iidevice iior iibulk iidrug
iisubstance iibetween iiregistered iiestablishments iiwithin iithe iisame iiparent, iisubsidiary,
iiand/or iiaffiliate iicompany.
Communication iifrom iithe iiCommission iito iithe iiCouncil iiand iithe iiEuropean iiParliament
iion iiMedical iiDevices ii(COM ii2003 ii386 iiFinal) ii- iiAnswers ii-The iiCommission's iipolicy
iiconclusions iion iithe iifunctioning iiof iithe iimedical iidevice iidirectives, iibased iion iithe
iiissues iihighlighted iiin iithe iireport iiof iithe iiMedical iiDevice iiExpert iiGroup ii(MDEG).
Companion iiDiagnostic ii(CDx/CoDx) ii- iiAnswers ii-An iiin iivitro iidiagnostic iidevice iior
iiimaging iitool iithat iiprovides iiinformation iithat iiis iiessential iifor iithe iisafe iiand iieffective
iiuse iiof iia iicorresponding iitherapeutic iiproduct.
Complaint ii- iiAnswers ii-Any iiwritten, iielectronic, iior iioral iicommunication iialleging
iideficiencies iirelated iito iithe iiidentity, iiquality, iidurability, iireliability, iisafety,
iieffectiveness, iior iiperformance iiof iia iiproduct iiafter iirelease iifor iidistribution.
Computer iiSystem iiValidation ii(CSV) ii- iiAnswers ii-The iidocumented iiprocess iiof
iiassuring iithat iia iicomputer iisystem iidoes iiexactly iiwhat iiit iiis iidesigned iito iido iiin iia
iiconsistent iiand iireproducible iimanner.
Conflict iiof iiInterest ii(COI) ii- iiAnswers ii-Situation iiin iiwhich iithe iiconcerns iior iiaims iiof
iitwo iidifferent iiparties iiare iiincompatible
Conformity iiAssessment ii- iiAnswers ii-The iisystematic iiexamination iiof iievidence
iigenerated iiand iiprocedures iiundertaken iiby iithe iimanufacturer, iiunder iirequirements
iiestablished iiby iithe iiregulatory iiauthority, iito iidetermine iia iimedical iidevice iiis iisafe iiand
iiperforms iias iiintended iiby iithe iimanufacturer iiand, iitherefore, iiconforms iito iithe
iiEssential iiPrinciples iiof iiSafety iiand iiPerformance iifor iiMedical iiDevices
