RAC PRACTICE EXAM 1 WITH
CORRECT DETAILED ANSWERS
Which kof kthe kfollowing kis kNOT krequired kfor kcompliance kunder k21 kCFR kPart k11
k(electronic krecords kand kelectronic ksignatures)?
A kManually kgenerated ktimestamped kaudit ktrails kto krecord kthe kdate kand ktime kof
koperator kentries kand kactions kthat kcreate, kmodify kor kdelete kelectronic krecords.
B kValidation kof ksystems kto kensure kaccuracy
C kAuthority kchecks kto kensure kthat konly kauthorized kpersonell kcan kcreate, kmodify
kor kdelete kelectronic krecords.
D kEstablishment kof kand kadherence kto kwritten kprocedures k- kcorrect kanswers k-A.
The kfinal kauthority kfor kensuring kthe kadequacy kof kan kInvestigational kNew kDrug
k(IND) kinformed kconsent kdocument kresides kwith kthe: k- kcorrect kanswers k-
Institutional kReview kBoard k(IRB)
A ksponsor kwishes kto kobtain kpermission kfrom kFDA kto ksubmit kan kANDA kfor ka
kdrug kproduct kthat kvaries kfrom kthe kReference kListed kDrug k(RLD) kin kroute kof
kadministration, kdosage kform, kor kstrength, kbut kanticipates kthat kthe klabeling kwill kbe
,kidentical kto kthat kof kthe kRLD. kWhat kprocess kshould kbe kused kto kapply kfor kthat
kpermission kfrom kFDA? k- kcorrect kanswers k-Suitability kPetition
A k505(b)(2) kNDA kis knot kan kappropriate kregulatory ksubmission kfor kthe kapproval kto
kmarket ka k- kcorrect kanswers k-New kchemical kentity kwhen kthe ksponsor khas ka kright
kof kreference kto kall kapplicable kpublished kstudies
Distribution krecords kfor kdrug kproducts kmust kreference kor kcontain: k- kcorrect
kanswers k-Name kand kaddress kof kthe kconsignee
A kmid-sized kpharmaceutical kcompany knegotiated kwith kFDA kto ksubmit ka kdraft
kPackage kInsert k(PI) kand kpatient kmedication kguide k(MedGuide) kin kannotated
kWord kformat kfor kinitial kFDA kreview, kand kcommitted kto ksubmit kthe kLabeling kin
kStructured kProduct kLabel
(SPL) kformat kupon kapproval kof ktheir kproduct. kWhat kis kthe kpreferred ktimeline kfor
kthis kpharmaceutical kcompany kto ksubmit kthe kSPL kformatted klabeling kupon kproduct
kapproval? k- kcorrect kanswers k-14 kdays
Adverse kevent kreporting kfor ka kmarketed kbiologics kproduct kis kNOT krequired kfor: k-
kcorrect kanswers k-Diagnostic knon-invasive ktest kkits
The kquality kassurance kmanager kof ka ksmall kcompany kconsisting kof k12 kemployees
kis kthe konly kinternal kauditor kfor kthe kcompany kand khas kbeen kperforming kall
kinternal kquality ksystem kaudits kfor kthree kyears. kThis kdoes knot kmeet kthe
krequirements kfor kperforming kinternal kquality ksystems kaudits kbecause k- kcorrect
kanswers k-Auditor kindependence khas knot kbeen kensured.
You khave kmodified kyour k510(k)-cleared kdevice kwith ka kSpecial k510(k). kIn kwhich
kcase kwould ka kSpecial k510(k) knot kbe kappropriate kfor kthe kdevice? k- kcorrect
kanswers k-You khave kchanged kthe kprimary kmechanism kof kaction.
Which kPremarket kApproval kApplication k(PMA) ksupplements kare kNOT ksubject kto
kuser kfee kexemption? k- kcorrect kanswers k-Real kTime kSupplement
A kmedical kdevice kcompany kallows kits ksales kforce kto kmaintain ka kproduct kinventory
kin kthe kfield. kThe kdevice khas kan kexpiration kdate kindicated kon kits klabeling. kA
ksales kperson knotes kthat kone kof khis kproducts khas kexpired kand kcontacts kthe
kheadquarters koffice kfor kdirection. kHe kis ktold kto kreturn kthe kproduct kto kthe
kheadquarter koffice kfor kreplacement. kThe kreturn kof kthis kproduct kis kconsidered kas
kwhat ktype kof krecall? k- kcorrect kanswers k-Not ka krecall—it kis kconsidered knormal
kstock krotation
A kcompany kis kdeveloping kan k(unapproved) kdrug-device kcombination kproduct kbut
kis knot ksure kto kwhich kcenter kit kshould ksubmit kits kmarketing kapplication. kThe
kcompany kshould kfirst ksubmit k- kcorrect kanswers k-A kRequest kfor kDesignation kto
kthe kOffice kof kCombination kProducts
, A kmedical kdevice kcompany kis kdeveloping ka kproduct kwith kdrug, kbiologic kand
kdevice kcomponents. kThe kproduct kand kindication khave knot kbeen kpreviously
kclassified kby kFDA. kWhat kis kthe kmost kappropriate kregulatory kpathway? k- kcorrect
kanswers k-A kRequest kfor kDesignation k(RFD) kshould kbe ksent kto kthe kOffice kof
kCombination kProducts k(OCP) kat kFDA kto kdetermine kthe kprimary kmode kof kaction
k(PMOA) kand kassign kthe kagency kwith kprimary kjurisdiction.
FDA's kOffice kof kGeneric kDrugs k(OGD) kremains kcommitted kto kthe k"first-in, kfirst-
reviewed" kreview korder kfor kthe kreviewing koriginal kAbbreviated kNew kDrug
kApplications k(ANDAs), kamendments kand ksupplements kunless kthere kis ka kspecific
kreason kto kexpedite kan kapplication. kWhat kis kNOT ka kspecific kreason kto kgrant
kexpedited kreview? k- kcorrect kanswers k-Products kthat kshow kevidence kof ksafety
kand keffectiveness kin ka knew ksubpopulation
A kfirm kis kpreparing ka k510(k), kpremarket knotification kto kFDA kfor kan kin kvitro
kdiagnostic ktest, ka kmicrohematocrit kanalyzer kthat, kamong kother kintended kuses,
kcan kdetermine kthe khematocrit kof ka kblood kdonor kprior kto kdonation kof ka kblood
kproduct. kThe kfirm kshould kaddress kthe k510(k) ksubmission kto: k- kcorrect kanswers k-
CBER
Notice kof kIntent kto kRevoke klicense kcan kbe kissued kfor kthe kfollowing kreason,
kEXCEPT
A kUnable kto kgain kaccess kto kthe kmanufacturing kplant, k
B kLicensed kproduct kare kno klonger ksafe kand keffective
C kFailure kto kreport kserious kadverse kevent,
D kManufacturer kfails kto kconform kto kapplicable kstandards k- kcorrect kanswers k-C
What kis kthe kformal kearly kcollaboration kmeeting kthat kwas kimplemented kthrough kthe
kFood kand kDrug kModernization kAct k(FDAMA)? k- kcorrect kanswers k-Agreement
kMeeting
The kAgreement kMeeting kis ka kformal kmeeting kto kagree kupon kthe kparameters kof
kthe kinvestigational kplan. kWhen ka kmeeting
request kis kreceived kby kFDA, kthe kmeeting kwill kbe kheld kwithin k30 kdays. kThe
kagreements kmade kat kthe kmeeting kare kprovided kin kwriting kto kthe ksponsor kand
kare kbinding kon kFDA. kRegulatory kReference: kEarly kCollaboration kMeetings kUnder
kthe kFDA kModernization kAct; kFinal kGuidance kfor kIndustry kand kfor kCDRH kStaff
k(February k2001).
A kUS kmedical kdevice kcontract kmanufacturer khas kcustomers kfor kwhom kit
kmanufactures kmedical kdevice kcomponents k(parts) kand kfinished kmedical kdevices.
kTo kdate, kall kproducts khave kbeen keither kparts kfor kClass kII kmedical kdevices kor
kClass kII kfinished kmedical kdevices. kThe kmanager kof knew kbusiness kcontacts kthe
kregulatory kmanager kto kassess kthe kimpact kof ka kpossible knew kcustomer
involving ka kClass kIII kdevice. kWhat kis kthe kfirst kquestion kthe kregulatory kmanager
kshould kask kin korder kto kbegin kassessing kthe kimpact kof kClass kIII kon kplant
CORRECT DETAILED ANSWERS
Which kof kthe kfollowing kis kNOT krequired kfor kcompliance kunder k21 kCFR kPart k11
k(electronic krecords kand kelectronic ksignatures)?
A kManually kgenerated ktimestamped kaudit ktrails kto krecord kthe kdate kand ktime kof
koperator kentries kand kactions kthat kcreate, kmodify kor kdelete kelectronic krecords.
B kValidation kof ksystems kto kensure kaccuracy
C kAuthority kchecks kto kensure kthat konly kauthorized kpersonell kcan kcreate, kmodify
kor kdelete kelectronic krecords.
D kEstablishment kof kand kadherence kto kwritten kprocedures k- kcorrect kanswers k-A.
The kfinal kauthority kfor kensuring kthe kadequacy kof kan kInvestigational kNew kDrug
k(IND) kinformed kconsent kdocument kresides kwith kthe: k- kcorrect kanswers k-
Institutional kReview kBoard k(IRB)
A ksponsor kwishes kto kobtain kpermission kfrom kFDA kto ksubmit kan kANDA kfor ka
kdrug kproduct kthat kvaries kfrom kthe kReference kListed kDrug k(RLD) kin kroute kof
kadministration, kdosage kform, kor kstrength, kbut kanticipates kthat kthe klabeling kwill kbe
,kidentical kto kthat kof kthe kRLD. kWhat kprocess kshould kbe kused kto kapply kfor kthat
kpermission kfrom kFDA? k- kcorrect kanswers k-Suitability kPetition
A k505(b)(2) kNDA kis knot kan kappropriate kregulatory ksubmission kfor kthe kapproval kto
kmarket ka k- kcorrect kanswers k-New kchemical kentity kwhen kthe ksponsor khas ka kright
kof kreference kto kall kapplicable kpublished kstudies
Distribution krecords kfor kdrug kproducts kmust kreference kor kcontain: k- kcorrect
kanswers k-Name kand kaddress kof kthe kconsignee
A kmid-sized kpharmaceutical kcompany knegotiated kwith kFDA kto ksubmit ka kdraft
kPackage kInsert k(PI) kand kpatient kmedication kguide k(MedGuide) kin kannotated
kWord kformat kfor kinitial kFDA kreview, kand kcommitted kto ksubmit kthe kLabeling kin
kStructured kProduct kLabel
(SPL) kformat kupon kapproval kof ktheir kproduct. kWhat kis kthe kpreferred ktimeline kfor
kthis kpharmaceutical kcompany kto ksubmit kthe kSPL kformatted klabeling kupon kproduct
kapproval? k- kcorrect kanswers k-14 kdays
Adverse kevent kreporting kfor ka kmarketed kbiologics kproduct kis kNOT krequired kfor: k-
kcorrect kanswers k-Diagnostic knon-invasive ktest kkits
The kquality kassurance kmanager kof ka ksmall kcompany kconsisting kof k12 kemployees
kis kthe konly kinternal kauditor kfor kthe kcompany kand khas kbeen kperforming kall
kinternal kquality ksystem kaudits kfor kthree kyears. kThis kdoes knot kmeet kthe
krequirements kfor kperforming kinternal kquality ksystems kaudits kbecause k- kcorrect
kanswers k-Auditor kindependence khas knot kbeen kensured.
You khave kmodified kyour k510(k)-cleared kdevice kwith ka kSpecial k510(k). kIn kwhich
kcase kwould ka kSpecial k510(k) knot kbe kappropriate kfor kthe kdevice? k- kcorrect
kanswers k-You khave kchanged kthe kprimary kmechanism kof kaction.
Which kPremarket kApproval kApplication k(PMA) ksupplements kare kNOT ksubject kto
kuser kfee kexemption? k- kcorrect kanswers k-Real kTime kSupplement
A kmedical kdevice kcompany kallows kits ksales kforce kto kmaintain ka kproduct kinventory
kin kthe kfield. kThe kdevice khas kan kexpiration kdate kindicated kon kits klabeling. kA
ksales kperson knotes kthat kone kof khis kproducts khas kexpired kand kcontacts kthe
kheadquarters koffice kfor kdirection. kHe kis ktold kto kreturn kthe kproduct kto kthe
kheadquarter koffice kfor kreplacement. kThe kreturn kof kthis kproduct kis kconsidered kas
kwhat ktype kof krecall? k- kcorrect kanswers k-Not ka krecall—it kis kconsidered knormal
kstock krotation
A kcompany kis kdeveloping kan k(unapproved) kdrug-device kcombination kproduct kbut
kis knot ksure kto kwhich kcenter kit kshould ksubmit kits kmarketing kapplication. kThe
kcompany kshould kfirst ksubmit k- kcorrect kanswers k-A kRequest kfor kDesignation kto
kthe kOffice kof kCombination kProducts
, A kmedical kdevice kcompany kis kdeveloping ka kproduct kwith kdrug, kbiologic kand
kdevice kcomponents. kThe kproduct kand kindication khave knot kbeen kpreviously
kclassified kby kFDA. kWhat kis kthe kmost kappropriate kregulatory kpathway? k- kcorrect
kanswers k-A kRequest kfor kDesignation k(RFD) kshould kbe ksent kto kthe kOffice kof
kCombination kProducts k(OCP) kat kFDA kto kdetermine kthe kprimary kmode kof kaction
k(PMOA) kand kassign kthe kagency kwith kprimary kjurisdiction.
FDA's kOffice kof kGeneric kDrugs k(OGD) kremains kcommitted kto kthe k"first-in, kfirst-
reviewed" kreview korder kfor kthe kreviewing koriginal kAbbreviated kNew kDrug
kApplications k(ANDAs), kamendments kand ksupplements kunless kthere kis ka kspecific
kreason kto kexpedite kan kapplication. kWhat kis kNOT ka kspecific kreason kto kgrant
kexpedited kreview? k- kcorrect kanswers k-Products kthat kshow kevidence kof ksafety
kand keffectiveness kin ka knew ksubpopulation
A kfirm kis kpreparing ka k510(k), kpremarket knotification kto kFDA kfor kan kin kvitro
kdiagnostic ktest, ka kmicrohematocrit kanalyzer kthat, kamong kother kintended kuses,
kcan kdetermine kthe khematocrit kof ka kblood kdonor kprior kto kdonation kof ka kblood
kproduct. kThe kfirm kshould kaddress kthe k510(k) ksubmission kto: k- kcorrect kanswers k-
CBER
Notice kof kIntent kto kRevoke klicense kcan kbe kissued kfor kthe kfollowing kreason,
kEXCEPT
A kUnable kto kgain kaccess kto kthe kmanufacturing kplant, k
B kLicensed kproduct kare kno klonger ksafe kand keffective
C kFailure kto kreport kserious kadverse kevent,
D kManufacturer kfails kto kconform kto kapplicable kstandards k- kcorrect kanswers k-C
What kis kthe kformal kearly kcollaboration kmeeting kthat kwas kimplemented kthrough kthe
kFood kand kDrug kModernization kAct k(FDAMA)? k- kcorrect kanswers k-Agreement
kMeeting
The kAgreement kMeeting kis ka kformal kmeeting kto kagree kupon kthe kparameters kof
kthe kinvestigational kplan. kWhen ka kmeeting
request kis kreceived kby kFDA, kthe kmeeting kwill kbe kheld kwithin k30 kdays. kThe
kagreements kmade kat kthe kmeeting kare kprovided kin kwriting kto kthe ksponsor kand
kare kbinding kon kFDA. kRegulatory kReference: kEarly kCollaboration kMeetings kUnder
kthe kFDA kModernization kAct; kFinal kGuidance kfor kIndustry kand kfor kCDRH kStaff
k(February k2001).
A kUS kmedical kdevice kcontract kmanufacturer khas kcustomers kfor kwhom kit
kmanufactures kmedical kdevice kcomponents k(parts) kand kfinished kmedical kdevices.
kTo kdate, kall kproducts khave kbeen keither kparts kfor kClass kII kmedical kdevices kor
kClass kII kfinished kmedical kdevices. kThe kmanager kof knew kbusiness kcontacts kthe
kregulatory kmanager kto kassess kthe kimpact kof ka kpossible knew kcustomer
involving ka kClass kIII kdevice. kWhat kis kthe kfirst kquestion kthe kregulatory kmanager
kshould kask kin korder kto kbegin kassessing kthe kimpact kof kClass kIII kon kplant
