DEVICE RAC Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Which FDA division would have primary jurisdiction over a vascular graft with
an antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
Correct Answer: C. CDRH
Explanation: The primary mode of action (PMOA) determines jurisdiction. Since
the graft is primarily a device (vascular graft) rather than a drug or biologic,
CDRH (Center for Devices and Radiological Health) has jurisdiction, even if it has
an antibiotic coating.
2. A company modifies a legally marketed device without changing intended use
or fundamental technology. If design outputs still meet design input
requirements, which submission is most appropriate?
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k)
Correct Answer: A. Special 510(k)
Explanation: A Special 510(k) is used when a modification does not affect
,intended use or technology and can be reviewed through design control
processes. Major changes would require a Traditional 510(k) instead.
3. Failure to meet 510(k) requirements for a device in commercial distribution is
considered:
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
Correct Answer: C. Misbranded
Explanation: Marketing a device without an approved 510(k) (when one is
required) is a violation of the misbranding provisions under the FD&C Act.
4. A company develops a new suture with the same dissolving time as a
competitor’s product due to a change in weaving configuration. When can it be
marketed?
A. After a new 510(k) submission
B. After submission in a periodic report
C. After reporting clinical studies in the annual report
D. After submission of a labeling change
Correct Answer: A. After a new 510(k) submission
Explanation: A significant change that affects safety or effectiveness requires a
new 510(k). The dissolving time change impacts performance and clinical
outcomes.
5. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
,C. Repackagers
D. Component manufacturers
Correct Answer: D. Component manufacturers
Explanation: Manufacturers of components (not finished medical devices) are
exempt from QSR requirements. However, the final device manufacturer must
ensure overall compliance.
6. A physician reports that a patient developed acute sepsis after treatment with
an approved device. The event is not listed in the package insert. By when must
the manufacturer report this to FDA?
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. In the next quarterly or annual report
Correct Answer: C. 30 calendar days
Explanation: Under MDR requirements, serious injuries not previously identified
in labeling must be reported within 30 days. Deaths and serious adverse events
also follow this timeline unless expedited reporting is required.
7. A device failure occurs more frequently than expected, and investigation
shows improper use by end users. Which action is most appropriate?
A. Revise the labeling
B. Recall the product
C. Redesign the product
D. Issue a “Dear Doctor” letter
Correct Answer: A. Revise the labeling
Explanation: If device misuse is due to unclear instructions, the FDA typically
expects the labeling to be revised to clarify instructions, warnings, or
precautions. A recall would be used for actual defects, not misuse
, 8. A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - ANSWER C
9. You have modified your 510(k) cleared device with a special 510(k). In which
of the following cases would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - ANSWER D
10. According to the QSR, when an investigation of a complaint is conducted all
of the following are requirements for inclusion in the record of the investigation
EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - ANSWER C
The QSR calls for the manufacturer of finished devices to carry out all of the
following EXCEPT:
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Which FDA division would have primary jurisdiction over a vascular graft with
an antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
Correct Answer: C. CDRH
Explanation: The primary mode of action (PMOA) determines jurisdiction. Since
the graft is primarily a device (vascular graft) rather than a drug or biologic,
CDRH (Center for Devices and Radiological Health) has jurisdiction, even if it has
an antibiotic coating.
2. A company modifies a legally marketed device without changing intended use
or fundamental technology. If design outputs still meet design input
requirements, which submission is most appropriate?
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k)
Correct Answer: A. Special 510(k)
Explanation: A Special 510(k) is used when a modification does not affect
,intended use or technology and can be reviewed through design control
processes. Major changes would require a Traditional 510(k) instead.
3. Failure to meet 510(k) requirements for a device in commercial distribution is
considered:
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
Correct Answer: C. Misbranded
Explanation: Marketing a device without an approved 510(k) (when one is
required) is a violation of the misbranding provisions under the FD&C Act.
4. A company develops a new suture with the same dissolving time as a
competitor’s product due to a change in weaving configuration. When can it be
marketed?
A. After a new 510(k) submission
B. After submission in a periodic report
C. After reporting clinical studies in the annual report
D. After submission of a labeling change
Correct Answer: A. After a new 510(k) submission
Explanation: A significant change that affects safety or effectiveness requires a
new 510(k). The dissolving time change impacts performance and clinical
outcomes.
5. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
,C. Repackagers
D. Component manufacturers
Correct Answer: D. Component manufacturers
Explanation: Manufacturers of components (not finished medical devices) are
exempt from QSR requirements. However, the final device manufacturer must
ensure overall compliance.
6. A physician reports that a patient developed acute sepsis after treatment with
an approved device. The event is not listed in the package insert. By when must
the manufacturer report this to FDA?
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. In the next quarterly or annual report
Correct Answer: C. 30 calendar days
Explanation: Under MDR requirements, serious injuries not previously identified
in labeling must be reported within 30 days. Deaths and serious adverse events
also follow this timeline unless expedited reporting is required.
7. A device failure occurs more frequently than expected, and investigation
shows improper use by end users. Which action is most appropriate?
A. Revise the labeling
B. Recall the product
C. Redesign the product
D. Issue a “Dear Doctor” letter
Correct Answer: A. Revise the labeling
Explanation: If device misuse is due to unclear instructions, the FDA typically
expects the labeling to be revised to clarify instructions, warnings, or
precautions. A recall would be used for actual defects, not misuse
, 8. A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - ANSWER C
9. You have modified your 510(k) cleared device with a special 510(k). In which
of the following cases would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - ANSWER D
10. According to the QSR, when an investigation of a complaint is conducted all
of the following are requirements for inclusion in the record of the investigation
EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - ANSWER C
The QSR calls for the manufacturer of finished devices to carry out all of the
following EXCEPT:
