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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 iihas 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. iiCDRH
In iithis iicombination iiof iia iidevice iiand iia iidrug, iithe iiprimary iimode iiof iiaction iiis iithat iiof
iithe iivascular iigraft ii(device). iiThe iiantibiotic iiis iisupportive iiin iithis iicase.
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. iiSpecial ii510(k)
A iiSpecial ii510(k) iiis iiallowed iiif iia iimodification iito iithe iilegally iimarketed iidevice iiis
iibeing iimade iithat iirelies iion iicompliance iiwith iidesign iicontrols, iiincluding iidesign
iivalidation. iiThe iiincentive iiprovided iifor iimanufacturers iito iichoose iithis iioption iiis iithat
iiODE iiintends iito iiprocess iispecial ii510(k)s iiwithin ii30 iidays iiof iireceipt. iiSee iithe iiCDRH
iiguidance iipublished iiin ii1998 iientitled iiThe iiNew ii510(k) iiParadigm ii- iiAlternate
iiApproaches iito iiDemonstrating iiSubstantial iiEquivalence iiin iiPremarket iiNotifications.
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. iiMisbranded
A iimarketed iidevice iithat iineeds iia ii510(k) iifor iicommercialization iibut iifailed iito iicomply
iiwith iithe iirequirements iiis iiconsidered iito iibe iiMisbranded. iiSee iithe iiFD&C iiAct, ii502(o).
,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 iiaffect iiefficacy. ii
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. iiThis iirequires iia iinew ii510(k)
iisince iisignificant iichange iiin iiproduct iiinstructions iimight iiaffect iiefficacy. ii
A iinew iiintended iiuse iirequires iia ii510(k) iiclearance.
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. ii30 iicalendar iidays
Serious iiinjury iimust iibe iireported iiwithin ii30 iidays iieven iiif iiit iiis iiexpected iiand iistated iiin
iithe iiIFU
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 iiproduct iireceipt iiand iitransfer
D. iiEnvironmentally iicontrolled iiareas iifor iiproducts iiwith iishelf iilife ii- iiAnswers ii-C.
iiProcedures iifor iiproduct iireceipt iiand iitransfer
Procedures iifor iireceipt iiand iitransfer iiof iiproducts iiare iirequired; iisee ii21 iiCFR
ii820.150(b).
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. iiNone iiof iithe iiabove.
According iito ii21 iiCFR ii807.22(b), iia iiseparate iiform iiFDA-2892 iishall iibe iisubmitted iifor
iieach iidevice iior iidevice iiclass iilisted iiwith iithe iiFDA. iiDevices iihaving iivariations iiin
iiphysical iicharacteristics iisuch iias iisize, iipackage, iishape, iicolor iior iicomposition iishould
iibe iiconsidered iito iibe iione iidevice: iiProvided, iiThe iivariation iidoes iinot iichange iithe
iifunction iior iiintended iiuse iiof iithe iidevice.
Per iithe iiQSR, iiwhen iian iiinvestigation iiof iia iicomplaint iiis iiconducted, iiall iiof iithe
iifollowing iiare iirequirements iifor iiinclusion iiin iiinvestigation iirecord 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. iiChanges iiin iiprocedures iicorrecting
iiquality iiproblems
The iirequirement iiis iifor iicorrective iiand iipreventative iiaction iiand iionly iineeded iiif
iicorrective iiaction iiwas iitaken iiper iiinvestigation. iiSee iiSec. ii820.198. iiComplaint iifiles.
The iiQSR iicalls iifor iifinished iidevice iimfgers iito iicarry iiout iiall iiof iithe iifollowing
iiEXCEPT:
A. iiQuality iiaudits iiconducted iiby iiindividuals iiwho iidon't iihave iidirect iiresponsibility iifor
iioperation iibeing iiaudited
B. iiAnnual iiaudits iiof iioperations
C. iiDocument iithe iidates iiand iiresults iiof iiquality iiaudits iiand iire-audits
D. iiHave iifindings iireviewed iiby iimanagement iiresponsible iifor iithe iimatters iiaudited ii-
iiAnswers ii-B. iiAnnual iiaudits iiof iioperations
Under iiCFR ii820.3(t), iian iiaudit iimust iibe iiperformed iiat iidefined iiintervals iiand iiat
iisufficient iifrequency iito iidetermine iithat iiquality iisystem iiactivities iicomply iiwith iiquality
iisystem iiprocedures iithat iithese iiprocedures iiare iiimplemented iieffectively iiand iithat
iiprocedures iiare iisuitable iito iiachieve iiquality iisystem iiobjectives.
According iito iithe iiQuality iiSystem iiRegulations, iire-testing iiand iire-evaluation iiof
iinonconforming iidevices iiafter iirework iiactivities iimust iibe iidocumented iiin iithe:
A. iiDevice iihistory iirecord
B. iiDevice iimaster iirecord
C. iiQuality iimanual
D. iiDesign iihistory iifile ii- iiAnswers ii-A. iiDevice iihistory iirecord
This iicontains iithe iidates iiof iimanufacture, iithe iiquantity iimanufactured, iithe iiquantity
iireleased iifor iidistribution, iicontrol iinumbers iiused iiand iithe iiacceptance iirecords iiwhich
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