DEVICE REGULATORY AFFAIRS CERTIFICATION (RAC)
(ACTUAL 2025/2026) EXAM QUESTIONS AND VERIFIED
ANSWERS
Under the Medical Device QSR, device design requirements
MUST meet the needs of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ---Answers----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 - ---Answers----
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 - ---
Answers----D
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ---Answers----D
A medical device is refused entry to the US. All of the following
may be reasons for refusal EXCEPT for the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - ---
Answers----A
Premarket Notification is required of manufacturers when
introducing:
A. New label size
, B. New Class II devices
C. A change in product name
D. Additional manufacturing sites - ---Answers----B
All of the following are considered General Controls under the
FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ---Answers----B
According to the QSR, suitable maintenance of equipment is
necessary to ensure that manufacturing specifications are
met. All of the following are requirements for the equipment
EXCEPT:
A. A written maintenance schedule is required
B. Allowable tolerances are posted on or near the equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented - ---
Answers----C
Which of the following devices would be regulated by CBER?
A) Warming device
(ACTUAL 2025/2026) EXAM QUESTIONS AND VERIFIED
ANSWERS
Under the Medical Device QSR, device design requirements
MUST meet the needs of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ---Answers----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 - ---Answers----
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 - ---
Answers----D
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ---Answers----D
A medical device is refused entry to the US. All of the following
may be reasons for refusal EXCEPT for the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - ---
Answers----A
Premarket Notification is required of manufacturers when
introducing:
A. New label size
, B. New Class II devices
C. A change in product name
D. Additional manufacturing sites - ---Answers----B
All of the following are considered General Controls under the
FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ---Answers----B
According to the QSR, suitable maintenance of equipment is
necessary to ensure that manufacturing specifications are
met. All of the following are requirements for the equipment
EXCEPT:
A. A written maintenance schedule is required
B. Allowable tolerances are posted on or near the equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented - ---
Answers----C
Which of the following devices would be regulated by CBER?
A) Warming device
