RAPS RAC |ACTUAL QUESTIONS AND VERIFIED
ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
A.
Question 2
The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the:
CORRECT ANSWER
Institutional Review Board (IRB)
Question 3
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?
1
,CORRECT ANSWER
Suitability Petition
Question 4
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a
CORRECT ANSWER
New chemical entity when the sponsor has a right of reference to all applicable
published studies
Question 5
Distribution records for drug products must reference or contain:
CORRECT ANSWER
Name and address of the consignee
Question 6
A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert
(PI) and patient medication guide (MedGuide) in annotated Word format for initial FDA
review, and committed to submit the Labeling in Structured Product Label
(SPL) format upon approval of their product. What is the preferred timeline for this
pharmaceutical company to submit the SPL formatted labeling upon product approval?
CORRECT ANSWER
14 days
Question 7
2
,Adverse event reporting for a marketed biologics product is NOT required for:
CORRECT ANSWER
Diagnostic non-invasive test kits
Question 8
The quality assurance manager of a small company consisting of 12 employees is the only
internal auditor for the company and has been performing all internal quality system
audits for three years. This does not meet the requirements for performing internal quality
systems audits because
CORRECT ANSWER
Auditor independence has not been ensured.
Question 9
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?
CORRECT ANSWER
You have changed the primary mechanism of action.
Question 10
Which Premarket Approval Application (PMA) supplements are NOT subject to user fee
exemption?
CORRECT ANSWER
Real Time Supplement
Question 11
3
, 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?
CORRECT ANSWER
Not a recall—it is considered normal stock rotation
Question 12
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
CORRECT ANSWER
A Request for Designation to the Office of Combination Products
Question 13
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?
CORRECT ANSWER
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.
Question 14
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),
4
ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
A.
Question 2
The final authority for ensuring the adequacy of an Investigational New Drug (IND)
informed consent document resides with the:
CORRECT ANSWER
Institutional Review Board (IRB)
Question 3
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?
1
,CORRECT ANSWER
Suitability Petition
Question 4
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a
CORRECT ANSWER
New chemical entity when the sponsor has a right of reference to all applicable
published studies
Question 5
Distribution records for drug products must reference or contain:
CORRECT ANSWER
Name and address of the consignee
Question 6
A mid-sized pharmaceutical company negotiated with FDA to submit a draft Package Insert
(PI) and patient medication guide (MedGuide) in annotated Word format for initial FDA
review, and committed to submit the Labeling in Structured Product Label
(SPL) format upon approval of their product. What is the preferred timeline for this
pharmaceutical company to submit the SPL formatted labeling upon product approval?
CORRECT ANSWER
14 days
Question 7
2
,Adverse event reporting for a marketed biologics product is NOT required for:
CORRECT ANSWER
Diagnostic non-invasive test kits
Question 8
The quality assurance manager of a small company consisting of 12 employees is the only
internal auditor for the company and has been performing all internal quality system
audits for three years. This does not meet the requirements for performing internal quality
systems audits because
CORRECT ANSWER
Auditor independence has not been ensured.
Question 9
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?
CORRECT ANSWER
You have changed the primary mechanism of action.
Question 10
Which Premarket Approval Application (PMA) supplements are NOT subject to user fee
exemption?
CORRECT ANSWER
Real Time Supplement
Question 11
3
, 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?
CORRECT ANSWER
Not a recall—it is considered normal stock rotation
Question 12
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
CORRECT ANSWER
A Request for Designation to the Office of Combination Products
Question 13
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?
CORRECT ANSWER
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.
Question 14
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),
4
