1 | Page
Device Rac Exam Questions With 100% Correct
Verified Answers | Latest Update 2026/2027 |
Graded A+.
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 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
Which of the following sections is required in a PMA?
,2 | Page
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
C. Repackagers
D. Component manufacturers -correct-answer-D
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:
, 3 | Page
A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action -correct-answer-C
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
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
Device Rac Exam Questions With 100% Correct
Verified Answers | Latest Update 2026/2027 |
Graded A+.
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 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
Which of the following sections is required in a PMA?
,2 | Page
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
C. Repackagers
D. Component manufacturers -correct-answer-D
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:
, 3 | Page
A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action -correct-answer-C
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
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
