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RAC-US - Regulatory AffairsExam
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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 followingEXCEPT?
Continue marketing the device for its Class IIindication
Update the current labeling to include the newindication
Proceed with a PMA submission toFDA
Request a face-to-face meeting post-panel meeting withFDA
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 marketingmaterials?
Company X has conducted clinical studies to demonstrate safety and effectiveness of deviceY
Device Y is approved for marketing in theUS
Warning: Device Y i not compatible with MRIequipment
Caution: Device Y, when improperly deployed, can causebleeding
Answer: B Question No3:
The Quality System Regulation calls for the manufacturer of finished devices to carry out all of the followingEXCEPT?
Quality audits conducted by individuals who do not have direct responsibility for the operation beingaudited.
Annual audits ofoperations
Document the dates and results of quality audits andre-audits
Have findings reviewed by management responsible for the mattersaudited
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)
Answer: D Question No5:
What is the formal early collaboration meeting that was implemented throught the Food and Drug Modernization Act(FDAMA)?
Answer: B Question No6:
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 followingEXCEPT"
The principle place of business in theUS
The packaging locationaddress
The address of the contractor who submitted the510(k)
The address of thedistributor
Answer: C Question No7:
A company intends to add an indication for use to a 510(k) device that is currently being marketed but has not yet been distributed. Which type of submission isappropriate?
An Investigation DeviceExemption
A traditional or abbreviated510(k)
Answer: D Question No8:
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 isconsidered:
Answer: D Question No9:
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 ofrecall?
Not a recall-it is considered normal stockrotation
Answer: A Question No10:
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 PMAimmediately
Petition CDRH to down-classify the device (de novoprocess)
Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as thepredicate
Submit this product for approval inEurope