//////////////////////////////////////////////////////////////////////////
Device /
RAC Exam Questions With Correct Answers
/ // // // // //
Which /
/division /
/has /
/primary /
/jurisdiction //over //a //vascular //graft //with //an //antibiotic //based //on //primary //mode //of //action?
A. //CDER
B. //CBER
C. //CDRH
D. //OCP //- //correct //answer(s) //✔✔ //C. //CDRH
In /
/this /
/combination /
/of //
a/
/device /
/and //
a //drug, //the //primary //mode //of //action //is //that //of //the //vascular //graft //(device). //The //antibiotic
//is //supportive //in //this //case.
A/
/company /
/wants /
/to /
/modify /
/its //legally //marketed //device //such //that //the //modification //does //not //affect //the //intended //use
,//////////////////////////////////////////////////////////////////////////
//or /
/alter /
/the /
/fundamental /
/scientific /
/technology /
/of /
/the /
/device. /
/If /
/the /
/design /
/outputs /
/of //the //modified //device //meet //the //design //input //requirements, //this //change //would //be //best
//filed //as //a(n):
A. //Special //510(k)
B. //Abbreviated //510(k)
C. //Traditional //510(k)
D. //De //novo //510(k) //- //correct //answer(s) //✔✔ //A. //Special //510(k)
A/
/Special /
/510(k) /
/is /
/allowed /
/if //
a/
/modification /
/to /
/the /
/legally /
/marketed /
/device /
/is /
,//////////////////////////////////////////////////////////////////////////
/being /
/made /
/that /
/relies /
/on /
/compliance /
/with /
/design /
/controls, /
/including /
/design /
/validation. /
/The /
/incentive /
/provided /
/for /
/manufacturers /
/to /
/choose /
/this /
/option /
/is /
/that /
/ODE /
/intends /
/to /
/process /
/special /
/510(k)s /
/within /
/30 /
/days /
/of /
/receipt. /
/See /
/the /
/CDRH /
/guidance /
, //////////////////////////////////////////////////////////////////////////
/published /
/in /
/1998 /
/entitled /
/The /
/New /
/510(k) /
/Paradigm //- /
/Alternate /
/Approaches //to //Demonstrating //Substantial //Equivalence //in //Premarket //Notifications.
Under /
/the /
/statutory /
/violations, /
/failure /
/to /
/meet /
/510(k) /
/requirements /
/for //
a/
/device //that //is //required //to //have //a //510(k) //and //is //in //commercial //distribution //is //considered
//to //be:
A. //Adulteration.
B. //Improper //use
C. //Misbranded
D. //Fraudulent //- //correct //answer(s) //✔✔ //C. //Misbranded
A/
/marketed /
/device /
/that /
Device /
RAC Exam Questions With Correct Answers
/ // // // // //
Which /
/division /
/has /
/primary /
/jurisdiction //over //a //vascular //graft //with //an //antibiotic //based //on //primary //mode //of //action?
A. //CDER
B. //CBER
C. //CDRH
D. //OCP //- //correct //answer(s) //✔✔ //C. //CDRH
In /
/this /
/combination /
/of //
a/
/device /
/and //
a //drug, //the //primary //mode //of //action //is //that //of //the //vascular //graft //(device). //The //antibiotic
//is //supportive //in //this //case.
A/
/company /
/wants /
/to /
/modify /
/its //legally //marketed //device //such //that //the //modification //does //not //affect //the //intended //use
,//////////////////////////////////////////////////////////////////////////
//or /
/alter /
/the /
/fundamental /
/scientific /
/technology /
/of /
/the /
/device. /
/If /
/the /
/design /
/outputs /
/of //the //modified //device //meet //the //design //input //requirements, //this //change //would //be //best
//filed //as //a(n):
A. //Special //510(k)
B. //Abbreviated //510(k)
C. //Traditional //510(k)
D. //De //novo //510(k) //- //correct //answer(s) //✔✔ //A. //Special //510(k)
A/
/Special /
/510(k) /
/is /
/allowed /
/if //
a/
/modification /
/to /
/the /
/legally /
/marketed /
/device /
/is /
,//////////////////////////////////////////////////////////////////////////
/being /
/made /
/that /
/relies /
/on /
/compliance /
/with /
/design /
/controls, /
/including /
/design /
/validation. /
/The /
/incentive /
/provided /
/for /
/manufacturers /
/to /
/choose /
/this /
/option /
/is /
/that /
/ODE /
/intends /
/to /
/process /
/special /
/510(k)s /
/within /
/30 /
/days /
/of /
/receipt. /
/See /
/the /
/CDRH /
/guidance /
, //////////////////////////////////////////////////////////////////////////
/published /
/in /
/1998 /
/entitled /
/The /
/New /
/510(k) /
/Paradigm //- /
/Alternate /
/Approaches //to //Demonstrating //Substantial //Equivalence //in //Premarket //Notifications.
Under /
/the /
/statutory /
/violations, /
/failure /
/to /
/meet /
/510(k) /
/requirements /
/for //
a/
/device //that //is //required //to //have //a //510(k) //and //is //in //commercial //distribution //is //considered
//to //be:
A. //Adulteration.
B. //Improper //use
C. //Misbranded
D. //Fraudulent //- //correct //answer(s) //✔✔ //C. //Misbranded
A/
/marketed /
/device /
/that /
