Exam (elaborations)
DEVICE RAC EXAM QUESTIONS AND ANSWERS
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DEVICE RAC EXAM QUESTIONS AND ANSWERS
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DEVICE RAC EXAM QUESTIONS ANDANSWERS
Which iidivision iiwould iihave iiprimary iijurisdiction iiover iia iivascular iigraft iiwith iian
iiantibiotic iibased iion iiprimary iimode iiof iiaction?
A. iiCDER
B. iiCBER
C. iiCDRH
D. iiOCP ii- iiAnswers ii-C
A iicompany iiwants iito iimodify iiits iilegally iimarketed iidevice iisuch iithat iithe iimodification
iidoes iinot iiaffect iithe iiintended iiuse iior iialter iithe iifundamental iiscientific iitechnology iiof
iithe iidevice. iiIf iithe iidesign iioutputs iiof iithe iimodified iidevice iimeet iithe iidesign iiinput
iirequirements, iithis iichange iiwould iibe iibest iifiled iias iia(n):
A. iiSpecial ii510(k)
B. iiAbbreviated ii510(k)
C. iiTraditional ii510(k)
D. iiDe iinovo ii510(k) ii- iiAnswers ii-A
Under iithe iistatutory iiviolations, iifailure iito iimeet ii510(k) iirequirements iifor iia iidevice iithat
iiis iirequired iito iihave iia ii510(k) iiand iiis iiin iicommercial iidistribution iiis iiconsidered iito iibe:
A. iiAdulteration.
B. iiImproper iiuse
C. iiMisbranded
D. iiFraudulent ii- iiAnswers ii-C
A iicompany's iicompetitor iiis iimarketing iia iiClass iiII iisuture iiwhich iidissolves iiduring iithe
iithird iiweek iiof iiuse. iiThe iicompany's iicurrent iiproduct iihas iito iibe iiremoved iiby iia
iiphysician. iiHowever, iia iichange iiin iiweaving iiconfiguration iigives iithis iiproduct iithe
iisame iidissolving iitime iias iithe iicompetitor's. iiWhen iican iithe iicompany's iinew iisuture iibe
iimarketed?
A. iiThis iirequires iia iinew ii510(k) iisince iisignificant iichange iiin iiproduct iiinstructions
iimight
affect iiefficacy.
B. iiAfter iisubmission iiin iia iiperiodic iireport
C. iiAfter iireporting iiclinical iistudies iiin iian iiannual iireport
D. iiAfter iisubmission iiof iilabeling iichange ii- iiAnswers ii-A
Which iiof iithe iifollowing iiis iiexempt iifrom iiGMP/QSR iiregulations?
A. iiRemanufacturers
, B. iiCustom iidevice iimanufacturers
C. iiRepackagers
D. iiComponent iimanufacturers ii- iiAnswers ii-D
A iiphysician iireports iito iia iimanufacturer iithat iia iipatient iiwas iihospitalized iiwith iiacute
iisepsis iiafter iitreatment iiwith iian iiapproved iidevice. iiThis iiside iieffect iiis iinot iilisted iiin
iithe iipackage iiinsert. iiThis iievent iimust iibe iireported iiby iithe iimanufacturer iito iiFDA iino
iilater iithan:
A. ii5 iicalendar iidays
B. ii15 iicalendar iidays
C. ii30 iicalendar iidays
D. iiThe iinext iiquarterly iior iiannual iireport ii- iiAnswers ii-C
If iia iidevice iifailure iiis iioccurring iiwith iigreater iithan iiexpected iifrequency iiand
iiinvestigation iiof iithe iiproblem iiimplicates iiimproper iiuse iiby iithe iiend iiuser, iiwhich iiof
iithe iifollowing iitypically iioccurs?
A. iiThe iilabeling iiis iirevised.
B. iiThe iiproduct iiis iirecalled.
C. iiThe iiproduct iiis iiredesigned.
D. iiA ii"Dear iiDoctor" iiletter iiis iiissued. ii- iiAnswers ii-A
A iihandling iiand iistorage iisystem iifor iimedical iidevices iimust iialways iiinclude:
A. iiProcedures iifor iirotation iiof iistock
B. iiSeparate iirooms iior iicages iifor iirelease iiand iiquarantine iiproducts
C. iiProcedures iifor iireceipt iiand iitransfer iiof iiproduct
D. iiEnvironmentally iicontrolled iiareas iifor iiproducts iiwith iishelf iilife ii- iiAnswers ii-C
You iihave iimodified iiyour ii510(k) iicleared iidevice iiwith iia iispecial ii510(k). iiIn iiwhich iiof
iithe iifollowing iicases iiwould iiyou iineed iito iicreate iia iinew iilisting iifor iithe iidevice?
A. iiYou iihave iiadded iinew iisizes iiand iishapes iiin iithe iiproduct iiportfolio.
B. iiYou iihave iichanged iithe iimaterial iicomposition iiof iithe iidevice.
C. iiYou iihave iichanged iithe iipackage iiof iithe iidevice.
D. iiNone iiof iithe iiabove. ii- iiAnswers ii-D
According iito iithe iiQSR, iiwhen iian iiinvestigation iiof iia iicomplaint iiis iiconducted iiall iiof
iithe iifollowing iiare iirequirements iifor iiinclusion iiin iithe iirecord iiof iithe iiinvestigation
iiEXCEPT:
A. iiThe iidates iiand iiresults iiof iithe iiinvestigation
B. iiThe iinature iiand iidetails iiof iithe iicomplaint
C. iiChanges iiin iiprocedures iicorrecting iiquality iiproblems
D. iiAny iireply iito iithe iicomplainant ii- iiAnswers ii-C
The iiQSR iicalls iifor iithe iimanufacturer iiof iifinished iidevices iito iicarry iiout iiall iiof iithe
iifollowing iiEXCEPT:
A. iiConduct iiquality iiaudits iiby iiindividuals iiwho iido iinot iihave iidirect iiresponsibility iifor
iithe iioperation iibeing iiaudited
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