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RAC Practice Exam Latest Updated 2024 With Complete Solutions

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RAC Practice Exam Latest Updated 2024 With Complete Solutions

You have modified your 510(k)-cleared device with a Special 510(k). In which case 
would a Special 510(k) not be appropriate for the device? -You have changed the 
primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are NOT subject to user 
fee exemption? - Real Time Supplement
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
A company is developing an (unapproved) drug-device combination product but is 
not sure to which center it should submit its marketing application. The company 
should first submit - A Request for Designation to the Office of Combination 
Products
A medical device company is developing a product with drug, biologic and device 
components. The product and indication have not been previously classified by 
FDA. What is the most appropriate regulatory pathway? - A Request for 
Designation (RFD) should be sent to the Office of Combination Products (OCP) at 
FDA to determine the primary mode of action (PMOA) and assign the agency with 
primary jurisdiction.
FDA's Office of Generic Drugs (OGD) remains committed to the "first-in, firstreviewed" review order for the reviewing original Abbreviated New Drug 
Applications (ANDAs), amendments and supplements unless there is a specific 
reason to expedite an application. What is NOT a specific reason to grant 
expedited review? - Products that show evidence of safety and effectiveness in a 
new subpopulation
A firm is preparing a 510(k), premarket notification to FDA for an in vitro 
diagnostic test, a microhematocrit analyzer that, among other intended uses, can 
determine the hematocrit of a blood donor prior to donation of a blood product. 
The firm should address the 510(k) submission to: - CBER
Notice of Intent to Revoke license can be issued for the following reason, EXCEPT
A Unable to gain access to the manufacturing plant, 
B Licensed product are no longer safe and effective
C Failure to report serious adverse event,
D Manufacturer fails to conform to applicable standards - C
What is the formal early collaboration meeting that was implemented through the 
Food and Drug Modernization Act (FDAMA)? - Agreement Meeting
The Agreement Meeting is a formal meeting to agree upon the parameters of the 
investigational plan. When a meeting
request is received by FDA, the meeting will be held within 30 days. The 
agreements made at the meeting are provided in writing to the sponsor and are 
binding on FDA. Regulatory Reference: Early Collaboration Meetings Under the FDA 
Modernization Act; Final Guidance for Industry and for CDRH Staff (February 2001).
Which of the following is NOT required for compliance under 21 CFR Part 11 
(electronic records and electronic signatures)?
A Manually generated timestamped audit trails to record the date and time of 
operator entries and actions that create, modify or delete electronic records.
B Validation of systems to ensure accuracy
C Authority checks to ensure that only authorized personell can create, modify or 
delete electronic records.
D Establishment of and adherence to written procedures - A.
The final authority for ensuring the adequacy of an Investigational New Drug (IND) 
informed consent document resides with the: - Institutional Review Board (IRB)
A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug 
product that varies from the Reference Listed Drug (RLD) in route of 
administration, dosage form, or strength, but anticipates that the labeling will be 
identical to that of the RLD. What process should be used to apply for that 
permission from FDA? - Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to 
market a - New chemical entity when the sponsor has a right of reference to all 
applicable published studies

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RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement 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 A company is developing an (unapproved) drug-device combination product but is not sure to which center it should submit its marketing application. The company should first submit - A Request for Designation to the Office of ...
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