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Device Rac Exam Questions With
100% Correct Verified Answers
A legally marketed device to which equivalence is drawn in a premarketing
submission is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device -correct-answer-C
A humanitarian device exemption differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required. -correct-answer-C
Removal of a distributed product for a reason NOT subject to legal action by FDA is
known as:
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A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action -correct-answer-C
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a
guidance on this technology and special controls have been established. This
change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA -correct-answer-B
Under the Medical Device QSR, device design requirements MUST meet the needs
of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user -correct-answer-D
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Under the IDE regulation, all of the following must be reported to the sponsor
within five working days EXCEPT:
A. A deviation from the investigational plan
B. Withdrawal of IRB approval
C. An unanticipated adverse device effect
D. Use of a device without informed consent -correct-answer-C
Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations -correct-answer-D
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
Device Rac Exam Questions With
100% Correct Verified Answers
A legally marketed device to which equivalence is drawn in a premarketing
submission is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device -correct-answer-C
A humanitarian device exemption differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required. -correct-answer-C
Removal of a distributed product for a reason NOT subject to legal action by FDA is
known as:
,2|Page
A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action -correct-answer-C
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a
guidance on this technology and special controls have been established. This
change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA -correct-answer-B
Under the Medical Device QSR, device design requirements MUST meet the needs
of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user -correct-answer-D
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Under the IDE regulation, all of the following must be reported to the sponsor
within five working days EXCEPT:
A. A deviation from the investigational plan
B. Withdrawal of IRB approval
C. An unanticipated adverse device effect
D. Use of a device without informed consent -correct-answer-C
Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations -correct-answer-D
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
