DEVICE RAC EXAM (New 2026/ 2027
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
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
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
C. Repackagers
D. Component manufacturers - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer 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
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
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
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
C. Repackagers
D. Component manufacturers - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer 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
