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RAPS Practice Exam 2024 (Devices) Questions and Answers
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RAPS Practice Exam 2024 (Devices) Questions and Answers
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RAPS Practice Exam 2024 (Devices)Questions and Answers
Prior iito iiinitiating iia iiclinical iitrail, iithe iicompany iidiscovers iithat iithe iinon-clinical iistudy
iiresults iiwere iiincorrectly iidocumented. iiWhich iiof iithe iifollowing iiis iithe iiMOST
iiappropriate iicourse iiof iiaction iifor iithe iicompany?
a) iiNotify iithe iiIRB iiethics iicommittee iiand iiobtain iia iire-approval iifor iithe iitrial
b) iiProceed iiwith iithe iiclinical iitrial, iibut iiinitiate iiprotocol iiamendments iito iiaddress iithe
iierrors
c) iiRe-evaluate iithe iinonclinical iidata iibefore iiproceeding iiwith iithe iiclinical iitrial
d) iiRevalidate iithe iiprotocol iiand iirepeat iithe iinonclinical iistudies iiif iinecessary ii-
iiAnswers ii-c) iiRe-evaluate iithe iinonclinical iidata iibefore iiproceeding iiwith iithe iiclinical
iitrial
Explanation: ii
Ensuring iithe iiaccuracy iiof iinonclinical iidata iiis iicrucial iibefore iistarting iia iiclinical iitrial.
iiRe-evaluating iithe iidata iiwill iihelp iiconfirm iithat iithe iifoundation iifor iithe iiclinical iistudy
iiis iireliable iiand iimeets iiregulatory iirequirements.
Your iicompany iiis iiplanning iito iimarket iia iiClass iiII iistand-alone iimedical iidevice
iisoftware iiin iithe iiUS. iiThe iisoftware iiwill iinot iibe iidistributed iiin iipackaged iiform iiand iiwill
iiinstead iibe iiprovided iifor iidownload iifrom iithe iicompany iiwebsite. iiAs iia iiregulatory
iilead, iiyou iiare iiasked iito iiprovide iiguidance iion iiUnique iiDevice iiIdentifier ii(UDI)
iicompliance iifor iithis iiadvice. iiYou iiadvise iithe iidevelopment iiteam iithat iithe iiProduct
iiIdentifier ii(PI) iiwill iineed iito iiinclude iithe iisoftware iiversion iinumber. iiWhen iiasked iihow
iithe iiUDI iimust iibe iipresented, iihow iido iiyou iiadvise iithe iiteam?
a) iiThe iiUDI iishould iibe iiconveyed iiin iian iieasily iireadable iiformat iiwithin iithe iisoftware
iiinterface iior iion iithe iiwebsite.
b) iiThe iiUDI iishould iibe iiconveyed iiin iian iieasily iireadable iiformat iithat iican iibe
iiaccessed iithrough iithe iiwebsite.
c) iiThe iiUDI iishould iibe iiconveyed iiin iian iieasily iireadable iiformat iiwithin iithe iisoftware
iiitself.
d) iiA iiand iiC ii- iiAnswers ii-d) iiA iiand iiC
Explanation: ii
a) iiThe iiUDI iishould iibe iiconveyed iiin iian iieasily iireadable iiformat iiwithin iithe iisoftware
iiinterface iior iion iithe iiwebsite. iiThis iiensures iithe iiUDI iiis iiavailable iiin iithe iicontext
iiwhere iithe iisoftware iiis iiaccessed iior iiused.
,c) iiThe iiUDI iishould iibe iiconveyed iiin iian iieasily iireadable iiformat iiwithin iithe iisoftware
iiitself. iiThis iiensures iithat iiusers iican iifind iiand iiverify iithe iiUDI iionce iithe iisoftware iiis
iidownloaded iiand iiin iiuse.
Both iia iiand iic iiensure iithat iithe iiUDI iiis iipresented iiin iia iiformat iithat iiis iiaccessible iiand
iireadable iiboth iiat iithe iipoint iiof iidownload iiand iiwithin iithe iisoftware.
What iisource iishould iithe iiregulatory iiprofessional iiconsult iito iidetermine iiwhen iia
iiproduct's iipatent iiand iiexclusivity iiwill iiexpire?
a) iiFederal iiRegister
b) iiThe iiOrange iiBook
c) iiPatent iiand iiTrademark iiOffice
d) iiCopyright iiOffice ii- iiAnswers ii-b) iiThe iiOrange iiBook
Explanation:
The iiOrange iiBook ii(Approved iiDrug iiProducts iiwith iiTherapeutic iiEquivalence
iiEvaluations) iilists iipatents iiand iiexclusivity iiinformation iifor iiFDA-approved iidrug
iiproducts. iiIt iiprovides iidetails iion iipatent iiexpiration iidates iiand iiperiods iiof iiexclusivity.
You iiare iitasked iiwith iihelping iidevelop iia iiregulatory iiintelligence iiprocedure iifor
iicontinuously iicollecting iiand iianalyzing iiregulatory iiinformation iipertaining iito
iichromosome iienumeration iiprobes ii(CEPs), iia iitype iiof iiin iivitro iidiagnostic ii(IVD)
iidevice. iiWhich iiof iithe iifollowing iiinputs iishould iibe iiconsidered iiwhen iicreating iithis
iiprocedure?
a) iiSources iiof iicontent ii(for iiexample ii- iiblogs iiand iiwhite iipapers)
b) iiIdentification iiof iiapplicable iigovernment iipublications iiand iiregulations
c) iiDatabases iicontaining iiinternational iistandards iiand iiguidelines
d) iiAll iioptions iilisted iiabove iishould iibe iiconsidered ii- iiAnswers ii-d) iiAll iioptions iilisted
iiabove iishould iibe iiconsidered
Explanation: ii
For iia iicomprehensive iiregulatory iiintelligence iiprocedure, iiit's iiimportant iito iiconsider iia
iivariety iiof iiinputs iiincluding iisources iiof iicontent, iigovernment iipublications, iiand
iidatabases iiof iistandards iiand iiguidelines iito iiensure iithorough iiand iiup-to-date
iiregulatory iianalysis.
According iito iiFDA, ii"remanufacturing" iiis iithe iiprocessing, iiconditioning, iirenovating,
iirepackaging, iirestoring, iior iiany iiother iiact iidone iito iia iifinished iidevice iithat iisignificantly
iichanges iiwhich iiof iithe iifollowing?
a) iiThe iiperformance/safety iispecification, iior iiintended iiuse iiof iithe iifinished iidevice
b) iiThe iiintended iiuse iior iifundamental iitechnology iiof iithe iidevice
c) iiThe iiperformance/safety iispecification iior iioperating iicharacteristics
d) iiThe iilabeling iiand/or iipackaging iiof iithe iifinished iidevice ii- iiAnswers ii-a) iiThe
iiperformance/safety iispecification, iior iiintended iiuse iiof iithe iifinished iidevice
, Explanation: ii
According iito iithe iiFDA, iiremanufacturing iiinvolves iisignificant iichanges iito iia iidevice
iithat iiaffect iiits iiperformance, iisafety iispecifications, iior iiintended iiuse.
In iithe iiUS, iiwhich iiof iithe iifollowing iiare iipermitted iito iibe iiincluded iiin iithe iiUDI
iiProduction iiIdentifier ii(PI) iion iia iidevice iilabel?
a) iiUniversal iiProduct iiCode ii(UPC) iiof iia iispecific iidevice
b) iiModel iinumber iiof iia iispecific iidevice
c) iiSerial iinumber iiof iia iispecific iidevice
d) iiB iiand iiC ii- iiAnswers ii-c) iiSerial iinumber iiof iia iispecific iidevice
Explanation: iiThe iiProduction iiIdentifier ii(PI) iiin iithe iiUDI iican iiinclude iithe iiserial
iinumber, iibut iinot iithe iiUniversal iiProduct iiCode ii(UPC) iior iimodel iinumber. iiThe iimodel
iinumber iiis iipart iiof iithe iiDevice iiIdentifier ii(DI), iinot iithe iiPI.
In iithe iicontext iiof iicybersecurity iiregulations, iia iilegacy iidevice iiis iione iithat:
a) iiHas iibeen iiin iiuse iiin iia iiclinical iienvironment iifor iilong iiperiods iiwithout iiupdates.
b) iiCannot iibe iireasonably iiprotected iiagainst iicurrent iicybersecurity iithreats
c) iiWas iidesigned iiand iideveloped iiprior iito iia iicompany's iiimplementation iiof
iicybersecurity iipolicies
d) iiHas iinot iibeen iireviewed iiby iian iiInformation iiSharing iiand iiAnalysis iiOrganization
ii(ISAO) ii- iiAnswers ii-b) iiCannot iibe iireasonably iiprotected iiagainst iicurrent
iicybersecurity iithreats
Explanation: ii
A iilegacy iidevice iiis iitypically iione iithat, iidue iito iiits iiage iior iidesign, iicannot iibe
iiadequately iiprotected iiagainst iimodern iicybersecurity iithreats.
A iicompany iiis iisubmitting iia iiPMA iifor iia iipermanent iiimplant. iiThe iicompany iihas
iiperformed iibiocompatibility iitesting iibased iion iiISO iirequirements iiand iibelieves iithe
iipackage iiis iicomplete. iiWhich iiof iithe iifollowing iitesting iidoes iithe iicompany iiabsolutely
iineed iito iidemonstrate iilong-term iisafety iiof iiits iidevice:
a) iiIntracutaneous iiirritation
b) iiGenotoxicity
c) iiAcutetoxicity
d) iiCarcinogenicity ii- iiAnswers ii-d) iiCarcinogenicity
Explanation: ii
Carcinogenicity iitesting iiis iicritical iifor iipermanent iiimplants iias iiit iiassesses iithe
iipotential iifor iithe iidevice iito iicause iicancer iiover iian iiextended iiperiod, iiwhich iiis
iiessential iifor iilong-term iisafety iievaluation.
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