RAC PRACTICE EXAM 1 EXAM WITH
CORRECT ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 - 2026
While reviewing the data for an upcoming New Drug Application (NDA)
submission, the in-house monitor found that the investigator's Curriculum
Vitae (CV) had not been updated throughout an Investigational New Drug
(IND) Study. According to FDA guidance on Form FDA 1572, how often should
the investigator's CV be updated? - ANSWERS-It does not need to be updated
A US medical device company wants to sell a Class III product in Australia,
where it has recently obtained approval. However, this product does not
currently have approval in the US. The product is manufactured in accordance
with the US Quality Systems Regulations. Which is the appropriate regulatory
action in the US before the product can be exported to Australia? - ANSWERS-
Send Simple Notification to FDA and obtain an 802 Certificate of Exportability
from FDA (if requested by Australia).
All of the following are types of regulatory inspections for a pharmaceutical
product EXCEPT?
A PAI, B For cause, C QSR, D GMP - ANSWERS-QSR
QSR audits are performed for medical devices
Which of the following is considered part of the Device Master Record?
,A Employee training record,
B Serial number label,
C Design reviews,
D Calibration records - ANSWERS-Serial number label
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 courses of action include all of the
following EXCEPT:
A Continue marketing the device for its Class,
B Update the current labeling to include the new indication,
C Proceed with a PMA submission to FDA.,
D Request a facetoface postpanel meeting with the FDA - ANSWERS-Update
the current labeling to include the new indication,
Which of the following statements is NOT true with respect to both
Investigational New Drug (IND) Applications and Investigational Device
Exemptions (IDEs) for significant-risk products?
A The investigational product must be manufactured in full compliance with
CGMP.
B Clinical studies must be reviewed and approved by an IRB,
C The IND or IDE goes into effect 30 days after submission if no response is
recieved from the FDA
D The application must include an environment risk assesment or a
categorical exclusion for not providing one. - ANSWERS-The investigational
product must be manufactured in full compliance with CGMP.
, Devices under approved IDEs are exempt from CGMP regulations except for
design control requirements; investigational new drugs must be compliant
with CGMP for finished pharmaceuticals.
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? - ANSWERS-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 - ANSWERS-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? -
ANSWERS-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, first-
reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a
CORRECT ACTUAL QUESTIONS AND
CORRECTLY WELL DEFINED ANSWERS
LATEST ALREADY GRADED A+ 2025 - 2026
While reviewing the data for an upcoming New Drug Application (NDA)
submission, the in-house monitor found that the investigator's Curriculum
Vitae (CV) had not been updated throughout an Investigational New Drug
(IND) Study. According to FDA guidance on Form FDA 1572, how often should
the investigator's CV be updated? - ANSWERS-It does not need to be updated
A US medical device company wants to sell a Class III product in Australia,
where it has recently obtained approval. However, this product does not
currently have approval in the US. The product is manufactured in accordance
with the US Quality Systems Regulations. Which is the appropriate regulatory
action in the US before the product can be exported to Australia? - ANSWERS-
Send Simple Notification to FDA and obtain an 802 Certificate of Exportability
from FDA (if requested by Australia).
All of the following are types of regulatory inspections for a pharmaceutical
product EXCEPT?
A PAI, B For cause, C QSR, D GMP - ANSWERS-QSR
QSR audits are performed for medical devices
Which of the following is considered part of the Device Master Record?
,A Employee training record,
B Serial number label,
C Design reviews,
D Calibration records - ANSWERS-Serial number label
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 courses of action include all of the
following EXCEPT:
A Continue marketing the device for its Class,
B Update the current labeling to include the new indication,
C Proceed with a PMA submission to FDA.,
D Request a facetoface postpanel meeting with the FDA - ANSWERS-Update
the current labeling to include the new indication,
Which of the following statements is NOT true with respect to both
Investigational New Drug (IND) Applications and Investigational Device
Exemptions (IDEs) for significant-risk products?
A The investigational product must be manufactured in full compliance with
CGMP.
B Clinical studies must be reviewed and approved by an IRB,
C The IND or IDE goes into effect 30 days after submission if no response is
recieved from the FDA
D The application must include an environment risk assesment or a
categorical exclusion for not providing one. - ANSWERS-The investigational
product must be manufactured in full compliance with CGMP.
, Devices under approved IDEs are exempt from CGMP regulations except for
design control requirements; investigational new drugs must be compliant
with CGMP for finished pharmaceuticals.
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? - ANSWERS-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 - ANSWERS-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? -
ANSWERS-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, first-
reviewed" review order for the reviewing original Abbreviated New Drug
Applications (ANDAs), amendments and supplements unless there is a
