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RAC Practice Exam 1 Questions and Answers (Latest Update 2025)
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RAC Practice Exam 1 Questions and Answers (Latest Update 2025)
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RAC Practice Exam 1 Questions andAnswers (Latest Update 2025)
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.
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)
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
,RAC Practice Exam 1 Questions and
Answers (Latest Update 2025)
that permission from FDA? - Correct Answer ✅ Suitability
Petition
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
Distribution records for drug products must reference or
contain: - Correct Answer ✅ 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
(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
,RAC Practice Exam 1 Questions and
Answers (Latest Update 2025)
Adverse event reporting for a marketed biologics product is
NOT required for: - Correct Answer ✅ 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 -
Correct Answer ✅ 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? - Correct Answer ✅ You have
changed the primary mechanism of action.
Which Premarket Approval Application (PMA) supplements are
NOT subject to user fee exemption? - Correct Answer ✅
Real Time Supplement
, RAC Practice Exam 1 Questions and
Answers (Latest Update 2025)
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
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
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.
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