1
RAC Practice Exam 1 Questions with Answers (100%
Correct Answers)
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)
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,2
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
Distribution records for drug products must reference or contain:—
Name and address of the consignee
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
© 2025 All rights reserved
,3
(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?—14 days
Adverse event reporting for a marketed biologics product is NOT
required for:—Diagnostic non-invasive test kits
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—Auditor independence has not been ensured.
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
© 2025 All rights reserved
, 4
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
© 2025 All rights reserved
RAC Practice Exam 1 Questions with Answers (100%
Correct Answers)
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)
© 2025 All rights reserved
,2
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
Distribution records for drug products must reference or contain:—
Name and address of the consignee
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
© 2025 All rights reserved
,3
(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?—14 days
Adverse event reporting for a marketed biologics product is NOT
required for:—Diagnostic non-invasive test kits
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—Auditor independence has not been ensured.
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
© 2025 All rights reserved
, 4
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
© 2025 All rights reserved
