RAC Practice Exam

1. Pass Regulatory Affairs Certification (RAC) exam in just 24 HOURS! 100% REAL EXAM QUESTIONSANSWERS Regulatory Affairs Certification(RAC) Buy Complete Questions Answers Filefrom http://www.exams4sure.net/raps/rac-gs-exam-questions- dumps.html 100% Exam Passing Guarantee & Money BackAssurance

2. SampleQuestions Question #1: Which of the following devices would be regulated byCBER? Warmingdevice Blood pressurecuff HIV diagnostic testkit Capillary blood collection tube Answer:C Question #2: For a medical Device, what is NOT a responsibility of the US Agent for a Foreign Establishment? Report adverse events under the Medical Device Reportingregulation Assisting FDA in communications with the foreignestablishment, Responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States,and Assisting FDA in scheduling inspections of the foreignestablishment. Answer:D Question #3: At completion of review of a 510(k), FDA may take the following actionsexcept: Declare device substantiallyequivalent Declare device not substantiallyequivalent State a 510(k) is not required to market thedevice Approve the device formarket Answer:D

3. Question #4: From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical devicedevelopment? Animal use testing to validate the design of yourdevice Bench testing to verify that your design performs asdesigned Biocompatibility/Toxicitytesting Functional/Safety/Performancetesting All of theabove Answer:E Question #5: With respect to a Non-Significant Risk device clinical trial, which of the following is NOT required before starting the trial? Informed consent of trial participants IRB approval of thetrial Financial disclosure by investigators Submission of the trial protocol to FDA forapproval Answer:D Question #6: The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the followingexcept: 21 CFR 50 Protection of HumanSubjects 21 CFR 56IRB 21 CFR 807 EstablishmentRegistration 21 CFR 812 IDEExemptions Answer:C

4. Question #7: A key component of a new device for which a PMA is being prepared is manufactured by a second company. Without revealing proprietary information to the finished product manufacturer, how can the component manufacturer make critical information available to FDA forreview? Submit a Device Master File(MAF) File its ownPMA Supply the applicable sections of the finished device manufacturer's PMA directly toFDA Include a certification in the finished device manufacturer's PMA that the proprietary information meets FDA'srequirements Answer:A Question #8: Under the official definition of a "device", all of the following are considered devicesexcept? X-rayfilm Sterilizers used for devicemanufacturing Eyeglass lenses andframes In vitro diagnostickit Answer:B Question #9: 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluationexcept: High FluxHemodialyzer Blood specimen collectiondevice Pistonsyringe Cardiopulmonary bypass bloodtubing

5. Answer:B • Question #10: • The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of thefollowing: • Finished devices, but notaccessories • Finished devices and components of finisheddevices • Finished devices and accessories to finisheddevices • Finished devices, components, and accessories to finisheddevices • Answer:C • Buy Complete Questions Answers Filefrom • http://www.exams4sure.net/raps/rac-gs-exam-questions- • dumps.html • 100% Exam Passing Guarantee & Money BackAssurance • PDF Version + Test Engine SoftwareVersion • 90 Days Free UpdatesService • Valid For AllCountries

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