RAC Questions Answers

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ANSWERS Regulatory Affairs Certification (RAC)
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• Sample Questions
• Question 1
• Which of the following devices would be regulated
  by CBER?
• Warming device
• Blood pressure cuff
• HIV diagnostic test kit
• 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
  Reporting regulation
• Assisting FDA in communications with the foreign
  establishment,
• 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
  foreign establishment.
• Answer D
• Question 3

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• Question 4
• From a pre-clinical viewpoint, which of the
  following constitute pre-clinical activities in
  medical device development?
• Animal use testing to validate the design of your
  device
• Bench testing to verify that your design performs
  as designed
• Biocompatibility/Toxicity testing
• Functional/Safety/Performance testing
• 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?
• Informed consent of trial participants
• IRB approval of the trial
• Financial disclosure by investigators
• Submission of the trial protocol to FDA for
  approval
• Answer D
• Question 6

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• 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?
• Submit a Device Master File (MAF)
• File its own PMA
• Supply the applicable sections of the finished
  device manufacturer's PMA directly to FDA
• 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?
• X-ray film
• Sterilizers used for device manufacturing
• Eyeglass lenses and frames
• In vitro diagnostic kit

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• Answer B
• Question 10
• The Quality System Regulation (QSR) for medical
  devices (21CFR 820) pertains to the
  manufacturing of which of the following
• Finished devices, but not accessories
• Finished devices and components of finished
  devices
• Finished devices and accessories to finished
  devices
• Finished devices, components, and accessories to
  finished devices
• Answer C
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