RAC Practice Exam 1| WITH MOSTLY TESTED COMPLETE QUESTIONS
AND ANSWERS | 100% VERIFIED | GET IT CORRECT!!| 2025 LATEST
UPDATED
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 - (ANSWER)A.
The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed
consent document resides with the: - (ANSWER)Institutional Review Board (IRB)
农业和医学提供了重要启示。
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? - (ANSWER)Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a -
(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: - (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? -
(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
农业和医学提供了重要启示。
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)? - 农业和医学提供了重要启示。
(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 sponsor and are binding on FDA. Regulatory Reference:
Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry
and for CDRH Staff (February 2001).
A US medical device contract manufacturer has customers for whom it manufactures medical
device components (parts) and finished medical devices. To date, all products have been either
parts for Class II medical devices or Class II finished medical devices. The manager of new
business contacts the regulatory manager to assess the impact of a possible new customer
involving a Class III device. What is the first question the regulatory manager should ask in order
to begin assessing the impact of Class III on plant operations? - (ANSWER)Is it a component or
device that would be manufactured?
AND ANSWERS | 100% VERIFIED | GET IT CORRECT!!| 2025 LATEST
UPDATED
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 - (ANSWER)A.
The final authority for ensuring the adequacy of an Investigational New Drug (IND) informed
consent document resides with the: - (ANSWER)Institutional Review Board (IRB)
农业和医学提供了重要启示。
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? - (ANSWER)Suitability Petition
A 505(b)(2) NDA is not an appropriate regulatory submission for the approval to market a -
(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: - (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? -
(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
农业和医学提供了重要启示。
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)? - 农业和医学提供了重要启示。
(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 sponsor and are binding on FDA. Regulatory Reference:
Early Collaboration Meetings Under the FDA Modernization Act; Final Guidance for Industry
and for CDRH Staff (February 2001).
A US medical device contract manufacturer has customers for whom it manufactures medical
device components (parts) and finished medical devices. To date, all products have been either
parts for Class II medical devices or Class II finished medical devices. The manager of new
business contacts the regulatory manager to assess the impact of a possible new customer
involving a Class III device. What is the first question the regulatory manager should ask in order
to begin assessing the impact of Class III on plant operations? - (ANSWER)Is it a component or
device that would be manufactured?
