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Regulatory Affairs Certification (RAC)

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Sample Questions

Question # 1:

Which of the following devices would be regulated by CBER?

A. Warming deviceB. Blood pressure cuffC. HIV diagnostic test kitD. 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?

E. Report adverse events under the Medical Device Reporting regulationF. Assisting FDA in communications with the foreign establishment,G. Responding to questions concerning the foreign establishment's products

that are imported or offered for import into the United States, andH. Assisting FDA in scheduling inspections of the foreign establishment.

Answer: D

Question # 3:

At completion of review of a 510(k), FDA may take the following actions except:

I. Declare device substantially equivalent

J. Declare device not substantially equivalent

K. State a 510(k) is not required to market the device

L. Approve the device for market

Answer: D

Question # 4:

From a pre-clinical viewpoint, which of the following constitute pre-clinical activities in medical device development?

A. Animal use testing to validate the design of your deviceB. Bench testing to verify that your design performs as designedC. Biocompatibility/Toxicity testingD. Functional/Safety/Performance testingE. All of the above

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?

F. Informed consent of trial participantsG. IRB approval of the trialH. Financial disclosure by investigatorsI. Submission of the trial protocol to FDA for approval

Answer: D

Question # 6:

The establishment, performance and auditing of a human-use clinical device trial requires conformance with all of the following except:

J. 21 CFR 50 Protection of Human SubjectsK. 21 CFR 56 IRBL. 21 CFR 807 Establishment RegistrationM. 21 CFR 812 IDE Exemptions

Answer: C

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 for review?

A. Submit a Device Master File (MAF)B. File its own PMAC. Supply the applicable sections of the finished device manufacturer's PMA

directly to FDAD. Include a certification in the finished device manufacturer's PMA that the

proprietary information meets FDA's requirements

Answer: A

Question # 8:

Under the official definition of a "device", all of the following are considered devices except?

E. X-ray filmF. Sterilizers used for device manufacturingG. Eyeglass lenses and framesH. In vitro diagnostic kit

Answer: B

Question # 9:

510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except:

I. High Flux HemodialyzerJ. Blood specimen collection deviceK. Piston syringeL. Cardiopulmonary bypass blood tubing

Answer: B

Question # 10:

The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following:

A. Finished devices, but not accessoriesB. Finished devices and components of finished devicesC. Finished devices and accessories to finished devicesD. Finished devices, components, and accessories to finished devices

Answer: C

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