PRACTICE RAC FINAL EXAM PAPER 2026
COMPLETE QUESTIONS AND VERIFIED
SOLUTIONS
⩥ 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? Answer: 14 days
⩥ Adverse event reporting for a marketed biologics product is NOT
required for:. 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. 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?.
Answer: You have changed the primary mechanism of action.
,⩥ Which Premarket Approval Application (PMA) supplements are NOT
subject to user fee exemption?. Answer: 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?. 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. 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?. 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.
⩥ 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 specific reason to expedite an application.
What is NOT a specific reason to grant expedited review?. Answer:
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:. Answer: 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. Answer: C
⩥ What is the formal early collaboration meeting that was implemented
through the Food and Drug Modernization Act (FDAMA)?. Answer:
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
COMPLETE QUESTIONS AND VERIFIED
SOLUTIONS
⩥ 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? Answer: 14 days
⩥ Adverse event reporting for a marketed biologics product is NOT
required for:. 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. 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?.
Answer: You have changed the primary mechanism of action.
,⩥ Which Premarket Approval Application (PMA) supplements are NOT
subject to user fee exemption?. Answer: 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?. 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. 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?. 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.
⩥ 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 specific reason to expedite an application.
What is NOT a specific reason to grant expedited review?. Answer:
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:. Answer: 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. Answer: C
⩥ What is the formal early collaboration meeting that was implemented
through the Food and Drug Modernization Act (FDAMA)?. Answer:
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
