Exam (elaborations)
RAC Sample Test with 100% correct Answers
- Course
- Institution
Exam of 38 pages for the course Device RAC at Device RAC (RAC Sample Test)
[Show more]
Content preview
RAC Sample TestWhich iiof iithe iifollowing iiis iiconsidered iipart iiof iithe iiDevice iiMaster iiRecord?
A. iiEmployee iitraining iirecord ii
B. iiLabeling iispecifications ii
C. iiDesign iireviews ii
D. iiCalibration iirecords ii- iiAnswers ii-B. iiLabeling iispecifications ii
Question iiFeedback: iiLabeling iispecifications iiare iipart iiof iithe iiDMR
A iicompany iihas iia iinew iioral iidrug, iiGOODDRUG, iiit iiwishes iito iimarket iiin iithe iiUS.
iiStudies iion iiintravenous iiGOODDRUG iihave iibeen iiconducted iiby iiseveral iiacademic
iicenters iidemonstrating iisafety iiand iiefficacy iiand iihave iibeen iipublished iiin iipeer-
reviewed iijournals. iiThe iimost-appropriate iimethod iito iigain iiapproval iiwould iibe iiby
iifiling iia: ii
A. iiANDA ii
B. iiSNDA ii
C. ii505(b)2 ii
D. ii505(b)1 ii- iiAnswers ii-C. ii505(b)2 ii
Question iiFeedback: iiSince iithe iidrug iihas iibeen iistudied iiand iithose iiresults iipublished,
iia iicomparability iistudy iibetween iiIV iiand iioral iidosage iiforms iiis iiacceptable iiunder iia
ii505(b)2
Your iicompany iiis iiconsidering iia iinew iidrug iiproduct. iiIt iihas iibeen iion iithe iimarket iifor
iimore iithan ii30 iiyears iiin iia iiforeign iicountry, iibut iihas iinever iibeen iiapproved iiin iithe iiUS.
iiTo iisell iithis iiproduct iiin iithe iiUS, iiyou iimay iido iithe iifollowing iiimmediately iiEXCEPT:
A. iiDetermine iimonograph iior iiNDA iistatus iiof iithe iiproduct ii
B. iiInitiate iiclinical iistudies iiin iithe iiforeign iicountry iito iisupport iithe iiclaims iisince iithe
iiclinical iidata iiare iiold iiand iiwould iinot iimeet iicurrent iirequirements ii
C. iiDetermine iiwhether iithis iiis iia iiNew iiChemical iiEntity ii
D. iiImport iithe iiproduct iiand iiuse iinew iilabeling ii- iiAnswers ii-D. iiImport iithe iiproduct iiand
iiuse iinew iilabeling
Question iiFeedback: iiThe iiimportation iiof iia iidrug iiproduct iito iibe iidistributed iiin iithe iiUS
iimust iimeet iiUS iiregulations, iiregardless iiof iiits iiapproved iistatus iiin iianother iicountry,
iitherefore iianswer ii4 iiis iicorrect.
A iicompany iiis iideveloping iia iicombination iiproduct iiconsisting iiof iia iidevice iithat iiinjects
iia iispecially iiformulated iismall iimolecule iidrug iifor iipain iiinto iithe iimuscle iitissue. iiWhich
iiof iithe iifollowing iidescribes iithe iibest iiUS iiregulatory iipath:
A. iiThe iiproduct iiis iiregulated iias iia iidrug
,B. iiThe iiproduct iiis iiregulated iiunder iiCDRH
C. iiThe iicompany iishould iifile iia iiBLA iito iiobtain iiUS iimarketing iiapproval
D. iiThe iicompany iishould iisubmit iia iirequest iifor iidesignation iito iiOCP ii- iiAnswers ii-A.
iiThe iiproduct iiis iiregulated iias iia iidrug
Question iiFeedback: iiPrimary iimode iiof iiaction iiis iithe iipain iidrug iiand iithe iidevice iiis iia
iidelivery iisystem
FDA iihas iiissued iia iiComplete iiResponse iiLetter iito iia iicompany. iiThe iicompany iiviews
iimany iiof iithe iideficiencies iias iiminor. iiThe iiregulatory iiprofessional iishould iimeet iiwith
iithe iiteam iito: ii
A. iiDevise iia iistrategy iifor iiresponding iito iiall iideficiencies iiidentified iiby iiFDA
B. iiDevise iia iistrategy iito iirespond iito iiany iiminor iideficiencies iiin iiorder iito iirestart iithe
iireview iiclock ii
C. iiInform iithe iiteam iia iiClass ii1 iiresubmission iihas iia iisix-month iireview iiclock
D. iiInform iithe iiteam iia iiClass ii2 iiresubmission iihas iia iithree-month iireview iiclock ii-
iiAnswers ii-A. iiDevise iia iistrategy iifor iiresponding iito iiall iideficiencies iiidentified iiby iiFDA
Question iiFeedback: iiResubmissions iipurport iito iianswer iiall iiof iithe iideficiencies
iineeding iito iibe iiaddressed iiby iithe iiapplicant iiprior iito iithe iioriginal iiapplication's
iiapproval iias iiset iiforth iiin iia iiprevious iiaction iiletter.
A iidrug iimanufacturer iicreates iia iigame-based iisimulation iito iiassist iidiabetes iipatients
iiwith iimanagement iiof iitheir iiblood iiglucose iilevels iiand iito iimotivate iithem iito iiadhere iito
iitheir iimedication iischedules. iiThe iigame iiwill iibe iibased iion iia iipassword iiprotected
iiwebsite iithat iiwill iibe iimade iiavailable iito iipatients iiwhen iian iiFDA-approved iidrug iiis
iiprescribed iito iithem. iiHow iiwill iithe iigame iimost iilikely iibe iiregulated iiby iiFDA?
A. iiIt iishould iibe iiincluded iias iipart iiof iithe iiNDA iisubmission
B. iiIt iiwill iibe iiregulated iias iia iiClass iiI iimedical iidevice
C. iiIt iiwill iibe iiregulated iias iian iiin iivitro iidiagnostic iiproduct
D. iiIt iiwill iinot iibe iian iiFDA iiregulated iiproduct ii- iiAnswers ii-D. iiIt iiwill iinot iibe iian iiFDA
iiregulated iiproduct
Question iiFeedback: iiThis iitype iiof ii"advertising" iiwould iifall iiunder iithe iicategory iiof iia
ii"help-seeking" iiadvertisement iibecause iithe iiproduct iiis iinot iinamed, iialthough iiit iilikely
iimakes iirecommendations iiabout iiactions iithat iimight iibe iitaken iibased iion iia iiparticular
iisymptom, iii.e., iilow iior iielevated iiglucose iilevels. iiUnlike iidrug iiand iidevice iipromotional
iilabeling iiand iiprescription iidrug iiand iirestricted iidevice iiadvertising, iidisease iiawareness
iicommunications iiare iinot iisubject iito iithe iirequirements iiof iithe iiFD&C iiAct iiand iiFDA
iiregulations.
For iiwhich iidevice iibelow iidoes iithe iiQuality iiSystem iiRegulation iirequire iithe iisame
iiprocedures iifor iiidentifying iithe iicontrol iinumber iifor iieach iiunit, iilot iior iibatch iiof iifinished
iidevices iias iithose iimandated iiby iithe iinew iiUDI iiRule?
A. iiSurgical iigloves
B. iiX-ray iimachines
,C. iiPacemakers
D. iiSyringes ii- iiAnswers ii-C. iiPacemakers
Question iiFeedback: iiAccording iito ii21 iiCFR ii820.65,"Each iimanufacturer iiof iia iidevice
iithat iiis iiintended iifor iisurgical iiimplant iiinto iithe iibody iior iito iisupport iior iisustain iilife iiand
iiwhose iifailure iito iiperform iiwhen iiproperly iiused iiin iiaccordance iiwith iiinstructions iifor
iiuse iiprovided iiin iithe iilabeling iican iibe iireasonably iiexpected iito iiresult iiin iia iisignificant
iiinjury iito iithe iiuser iishall iiestablish iiand iimaintain iiprocedures iifor iiidentifying iiwith iia
iicontrol iinumber iieach iiunit, iilot, iior iibatch iiof iifinished iidevices iiand iiwhere iiappropriate
iicomponents." iiThe iiPacemaker iiis iia iiClass iiIII iiimplantable iidevice iiand iisubject iito ii21
iiCFR ii820.65. ii(Sec. ii820.65 iiTraceability- iiEach iimanufacturer iiof iia iidevice iithat iiis
iiintended iifor iisurgical iiimplant iiinto iithe iibody iior iito iisupport iior iisustain iilife iiand iiwhose
iifailure iito iiperform iiwhen iiproperly iiused iiin iiaccordance iiwith iiinstructions iifor iiuse
iiprovided iiin iithe iilabeling iican iibe iireasonably iiexpected iito iiresult iiin iia iisignificant
iiinjury iito iithe iiuser iishall iiestablish iiand iimaintain iiprocedures iifor iiidentifying iiwith iia
iicontrol iinumber iieach iiunit, iilot, iior iibatch iiof iifinished iidevices iiand iiwhere iiappropriate
iicomponents. iiThe iiprocedures iishall iifacilitate iicorrective iiaction. iiSuch iiidentification
iishall iibe iidocumented iiin iithe iiDHR.)
Your iicompany iiis iideveloping iia iinew iidrug iito iibe iideveloped iiand iiused iiin iicombination
iiwith iia iicystoscopic iilight iidevice iifor iithe iiearly iidetection iiof iibladder iicancer. iiYou iiare
iiasked iito iidevelop iian iioverall iiregulatory iistrategy. iiThe iifirst iistep iiyou iiundertake iiis:
A. iiSubmit iia iiRequest iifor iiDesignation iito iiFDA iiOffice iiof iiCombination iiProducts iifor
iidetermination iiof iithe iilead iicenter iifor iiprimary iijurisdiction iifor iithe iicombination
iiproduct.
B. iiMake iia iipreliminary iiinternal iicompany iidetermination iiof iithe iicombination iiproduct's
iiprimary iimode iiof iiaction.
C. iiSubmit iian iiIND iialong iiwith iia iiRequest iifor iiDesignation iito iiFDA iiCDER iiOffice iiof
iiOncology iiDrug iiProducts ii(OODP).
D. iiSubmit iia iirequest iifor iidesignation iito iiFDA iiCDRH iiand iinotify iithe iiOffice iiof
iiCombination iiProducts ii- iiAnswers ii-B. iiMake iia iipreliminary iiinternal iicompany
iidetermination iiof iithe iicombination iiproduct's iiprimary iimode iiof iiaction.
Question iiFeedback: iiIt iiis iiimportant iito iidetermine iithe iiprimary iimode iiof iiaction iifirst iito
iibe iiable iito iimake iia iirecommendation iias iito iiwhich iiagency iicomponent iishould iihave
iiprimary iijurisdiction, iito iibe iifollowed iiby iia iirequest iifor iidesignation iito iiFDA iiOCP iiif
iideemed iinecessary iiwhen iithe iiproduct's iiclassification iior iithe iiagency iicenter iito iiwhich
iiit iishould iibe iiassigned iiin iiunclear iior iiin iidispute.
A iikey iipharmaceutical iiproduct iiparameter iihas iia iispecification iirange iiof ii90-100.
iiWhich iiof iithe iifollowing iipostmarketing iispecification iichanges iiwould iirequire iiFDA
iinotification iiprior iito iimaking iithe iichange?
A. ii89-100
B. ii90-99
C. ii95 ii+/- ii5
D. ii95-100 ii- iiAnswers ii-A. ii89-100
, Question iiFeedback: iiNotification iiis iirequired iiwhen iithe iispecification iirange iiis
iiwidened. iiVIII. iiSpecifications: iiB. iiMajor iiChanges ii(Prior iiApproval iiSupplement) iiThe
iifollowing iiare iiexamples iiof iichanges iiin iispecifications iiconsidered iito iihave iia
iisubstantial iipotential iito iihave iian iiadverse iieffect iion iithe iiidentity, iistrength, iiquality,
iipurity, iior iipotency iiof iia iidrug iiproduct iias iithese iifactors iimay iirelate iito iithe iisafety iior
iieffectiveness iiof iithe iidrug iiproduct. iiC. iiModerate iiChanges ii(Supplement—Changes
iiBeing iiEffected) iiSupplement—Changes iiBeing iiEffected iiin ii30 iiDays iib. iiRelaxing iian
iiacceptance iicriterion
Which iiof iithe iifollowing iistatements iiis iiNOT iitrue iifor iiPhase iiI iiInvestigational iiNew
iiDrug ii(IND) iiApplications iiand iiInvestigational iiDevice iiExemptions ii(IDEs) iifor
iisignificant-risk iiproducts?
A. iiThe iiinvestigational iiproduct iimust iibe iimanufactured iiin iifull iicompliance iiwith iiCGMP
ii
B. iiClinical iistudy iiprotocols iimust iibe iireviewed iiand iiapproved iiby iian iiInstitutional
iiReview iiBoard
C. iiThe iiIND iior iiIDE iigoes iiinto iieffect ii30 iidays iiafter iiFDA iireceives iithe iiapplication,
iiunless iiFDA iinotifies iithe iisponsor iiotherwise ii
D. iiThe iiapplication iimust iiinclude iian iienvironmental iiimpact iistatement iithat iicontains iia
iiclaim iifor iicategorical iiexclusion iior iian iienvironmental iiassessment ii- iiAnswers ii-A. iiThe
iiinvestigational iiproduct iimust iibe iimanufactured iiin iifull iicompliance iiwith iiCGMP ii
Question iiFeedback: iiAccording iito iiCFR ii210, ii2(c), ii"An iiinvestigational iidrug iifor iiuse
iiin iia iiphase ii1 iistudy, iias iidescribed iiin ii312.21(a) iiof iithis iichapter, iiis iisubject iito iithe
iistatutory iirequirements iiset iiforth iiin ii21 iiU.S.C. ii351(a)(2)(B). iiThe iiproduction iiof iisuch
iidrug iiis iiexempt iifrom iicompliance iiwith iithe iiregulations iiin iipart ii211 iiof iithis iichapter."
iiHowever, iibased iion iiFDA iiguidance, iiPhase ii1 iiinvestigational iidrugs iishould iibe
iimanufactured iiwith iithe iiapplication iiof iisome ii(not iifull) iiCGMP.
What iitype iiof iicommunication iiwill iiFDA iisend iian iiapplicant iiwhen iithe iireview iidivision
iiconcludes iian iiNDA iior iiANDA iicannot iibe iiapproved iiin iiits iipresent iiform iiand iicertain
iiadditional iiinformation iior iiclarifications iiare iineeded? ii
A. iiNon-approvable iiletter
B. iiComplete iiresponse iiletter
C. iiNon-approval iiletter
D. iiApprovable iiletter ii- iiAnswers ii-B. iiComplete iiresponse iiletter
Question iiFeedback: iiAll iideficiencies iiidentified iiby iiFDA iiwill iibe iiin iithe iicomplete
iiresponse iiletter. iiThe iiletter iialso iiwill iireflect iithe iireview iiof iithe iientire iiapplication
iiand/or iiamendments iisubmitted.
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 iidevice 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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller millyphilip. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $12.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
84669 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now