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Sample Questions
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• Question No 1
• While seeking a new Class III indication for a
  medical device that is currently on the market as
  Class II, a company received a vote of
  "non-approvable" from an FDA Advisory Panel.
  Possible course of action includes all of the
  following EXCEPT?
• Continue marketing the device for its Class II
  indication
• Update the current labeling to include the new
  indication
• Proceed with a PMA submission to FDA
• Request a face-to-face meeting post-panel meeting
  with FDA
• Answer B
• Question No 2
• Company X is developing marketing materials for a
  Class II medical device known as "Y". In one
  marketing piece, the company talks about the
  clinical data supporting the marketing of the
  device. Which of the following statements is
  illegal and should NOT be included int eh
  marketing materials?
• Company X has conducted clinical studies to
  demonstrate safety and effectiveness of device Y
• Device Y is approved for marketing in the US
• Warning Device Y i not compatible with MRI
  equipment
• Caution Device Y, when improperly deployed, can
  cause bleeding
• Answer B Question No 3
• The Quality System Regulation calls for the
  manufacturer of finished devices to carry out all
  of the following EXCEPT?
• Quality audits conducted by individuals who do
  not have direct responsibility for the operation
  being audited.
• Annual audits of operations
• Document the dates and results of quality audits
  and re-audits
• Have findings reviewed by management responsible
  for the matters audited

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• Question No 4
• The following are required per 21 CFR Part 820
  Quality System Regulation (QSR) EXCEPT?
• Device History Record (DHR)
• Device Master Record (DMR)
• Design History File (DHF)
• Quality Manual (QM)
• Answer D Question No 5
• What is the formal early collaboration meeting
  that was implemented throught the Food and Drug
  Modernization Act (FDAMA)?
• PDP Meeting
• Agreement Meeting
• Pre-IDE Meeting
• Pre-PMA Meeting
• Answer B Question No 6
• You are a German-based device manufacturer whose
  device is packaged in Ireland and sold in the US
  through a US-based company. The 510(k) was
  written by a contract organization. The label of
  our product may indicated any of the following
  EXCEPT"
• The principle place of business in the US
• The packaging location address
• The address of the contractor who submitted the
  510(k)
• The address of the distributor
• Answer C Question No 7

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• Answer D Question No 8
• A company begins to market its new device, a
  pacemaker (Class III) the same day that its
  regulatory professional mails the Premaket
  Approval Application (PMA) to FDA. The pacemaker
  is considered
• Legally marketed
• Misbranded
• Investigational
• Adulterated
• Answer D Question No 9
• A medical device company allows its sales force
  to maintain a product inventory in the field.
  The device has an expiration date indicated on
  its labeling. A sales person notes that one of
  his products has expired and contacts the
  headquarters office for direction. He is told to
  return the product to the headquarter office for
  replacement. The return of this product is
  considered as what type of recall?
• Not a recall-it is considered normal stock
  rotation
• Class I recall
• Class II recall
• Class III recall
• Answer A Question No 10
• When FDA declares a device from a 510(k)
  application to be Not Substantially Equivalent
  (NSE) and requires a PMA. What is the most
  practicable first option for a company at this
  stage?
• File a PMA immediately
• Petition CDRH to down-classify the device (de
  novo process)
• Resubmit a 510(k) with new data to demonstrate
  the device is at least as safe and effective as
  the predicate
• Submit this product for approval in Europe
• Answer C

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