////////////////////////////////////////////////////////////////////////////
RAC Exam Questions With Correct Answers
// // // // //
drug //- /
/correct /
/answer(s) //✔✔ //Any //article //intended //for //use //in //the //diagnosis, //cure, //mitigation, //treatment
//or //prevention //of //disease //in //man.
medical /
/device //- /
/correct /
/answer(s) /
/✔✔ /
/An /
/instrument, /
/apparatus, /
/implement, /
/machine, /
/contrivance, /
/implant, /
/in /
/vitro /
/reagent /
/or /
/similar /
/or /
/relate /
/article, /
/including /
/any /
/component, /
/part /
/or /
/accessory /
/intended /
/for /
,////////////////////////////////////////////////////////////////////////////
/the /
/use /
/in /
/diagnosis /
/of /
/disease /
/or /
/other /
/conditions, /
/or /
/in /
/the /
/cure, /
/mitigation, /
/treatment /
/or /
/prevention /
/of /
/disease /
/on /
/man /
/or /
/other /
/animals /
/intended /
/to /
/affect /
/the /
/structure /
/of /
/any /
/function /
/of /
/the /
/body /
/of /
/man /
/or /
,////////////////////////////////////////////////////////////////////////////
/other /
/animals, /
/and /
/which /
/does /
/not /
/achieve /
/its /
/primary /
/intended /
/purposes /
/through /
/chemical /
/action /
/within /
/or /
/on //the //body, //and //which //is //not //dependent //upon //being //metabolized //for //the //achievement
//of //its //primary //intended //purposes //(FD&C //Act //Section //201)
DRLS //- //correct //answer(s) //✔✔ //Drug //Registration //and //Listing //System
FURLS //- /
/correct /
/answer(s) /
/✔✔ /
/FDA /
/Unified /
/Registration /
/and /
/Listing /
/System //for //establishment //registration //of //medical //device //operators //and //distrubutors).
eDRLS //- //correct //answer(s) //✔✔ //electronic //Drug //Registration //and //Listing //System
, ////////////////////////////////////////////////////////////////////////////
MDUFMA //- /
/correct /
/answer(s) /
/✔✔ /
/Medical /
/Device /
/User /
/Fee //and //Modernization //Act //2002. //Required //electronic //medical //device //event //reporting.
MDR //- //correct //answer(s) //✔✔ //System //used //for //event //Reporting //for //device //manufacturers
//and //importers
Importer //- /
/correct /
/answer(s) /
/✔✔ //Any //importer //who //furthers //the //marketing //of //a //device //from //a //foreign //manufacturer
//to /
/the /
/person /
/who /
/makes /
/final /
/delivery /
/or /
/sale /
/of /
/the /
/device /
/to /
/the /
/ultimate //consumer //or //user, //but //does //not //repackage, //or //otherwise //change //the //container,
//wrapper, /
/or /
/labeling /
/of /
/the /
RAC Exam Questions With Correct Answers
// // // // //
drug //- /
/correct /
/answer(s) //✔✔ //Any //article //intended //for //use //in //the //diagnosis, //cure, //mitigation, //treatment
//or //prevention //of //disease //in //man.
medical /
/device //- /
/correct /
/answer(s) /
/✔✔ /
/An /
/instrument, /
/apparatus, /
/implement, /
/machine, /
/contrivance, /
/implant, /
/in /
/vitro /
/reagent /
/or /
/similar /
/or /
/relate /
/article, /
/including /
/any /
/component, /
/part /
/or /
/accessory /
/intended /
/for /
,////////////////////////////////////////////////////////////////////////////
/the /
/use /
/in /
/diagnosis /
/of /
/disease /
/or /
/other /
/conditions, /
/or /
/in /
/the /
/cure, /
/mitigation, /
/treatment /
/or /
/prevention /
/of /
/disease /
/on /
/man /
/or /
/other /
/animals /
/intended /
/to /
/affect /
/the /
/structure /
/of /
/any /
/function /
/of /
/the /
/body /
/of /
/man /
/or /
,////////////////////////////////////////////////////////////////////////////
/other /
/animals, /
/and /
/which /
/does /
/not /
/achieve /
/its /
/primary /
/intended /
/purposes /
/through /
/chemical /
/action /
/within /
/or /
/on //the //body, //and //which //is //not //dependent //upon //being //metabolized //for //the //achievement
//of //its //primary //intended //purposes //(FD&C //Act //Section //201)
DRLS //- //correct //answer(s) //✔✔ //Drug //Registration //and //Listing //System
FURLS //- /
/correct /
/answer(s) /
/✔✔ /
/FDA /
/Unified /
/Registration /
/and /
/Listing /
/System //for //establishment //registration //of //medical //device //operators //and //distrubutors).
eDRLS //- //correct //answer(s) //✔✔ //electronic //Drug //Registration //and //Listing //System
, ////////////////////////////////////////////////////////////////////////////
MDUFMA //- /
/correct /
/answer(s) /
/✔✔ /
/Medical /
/Device /
/User /
/Fee //and //Modernization //Act //2002. //Required //electronic //medical //device //event //reporting.
MDR //- //correct //answer(s) //✔✔ //System //used //for //event //Reporting //for //device //manufacturers
//and //importers
Importer //- /
/correct /
/answer(s) /
/✔✔ //Any //importer //who //furthers //the //marketing //of //a //device //from //a //foreign //manufacturer
//to /
/the /
/person /
/who /
/makes /
/final /
/delivery /
/or /
/sale /
/of /
/the /
/device /
/to /
/the /
/ultimate //consumer //or //user, //but //does //not //repackage, //or //otherwise //change //the //container,
//wrapper, /
/or /
/labeling /
/of /
/the /
