DEVICE RAC FINAL EXAM 2026/2027 QUESTIONS AND
SOLUTIONS RATED A+
✔✔MDUFMA authorized 3rd party establishment inspections under carefully prescribed
conditions. All the following prescribed conditions about 3rd party establishment
inspections are true EXCEPT:
A. The establishment must market at least one device in the US and must market a
device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends to use and FDA
must agree to the selection. - ✔✔B
✔✔FDA has sent a warning letter citing mislabeling of a small manufacturer's
artificial knee device. The regulatory affairs professional should first contact the:
A. Compliance Branch in their district
B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation
C. Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
in CDRH.
D. CDRH Ombudsman - ✔✔A
✔✔Inspections of device components received from a supplier may frequently reveal
product quality deficiencies. To avoid these instances, the supplier should first have:
A. Expert GMP knowledge
B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
D. An internal audit program - ✔✔B
✔✔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 - ✔✔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. - ✔✔C
, ✔✔Removal of a distributed product for a reason NOT subject to legal action by FDA is
known as:
A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔D
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
SOLUTIONS RATED A+
✔✔MDUFMA authorized 3rd party establishment inspections under carefully prescribed
conditions. All the following prescribed conditions about 3rd party establishment
inspections are true EXCEPT:
A. The establishment must market at least one device in the US and must market a
device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends to use and FDA
must agree to the selection. - ✔✔B
✔✔FDA has sent a warning letter citing mislabeling of a small manufacturer's
artificial knee device. The regulatory affairs professional should first contact the:
A. Compliance Branch in their district
B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation
C. Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
in CDRH.
D. CDRH Ombudsman - ✔✔A
✔✔Inspections of device components received from a supplier may frequently reveal
product quality deficiencies. To avoid these instances, the supplier should first have:
A. Expert GMP knowledge
B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
D. An internal audit program - ✔✔B
✔✔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 - ✔✔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. - ✔✔C
, ✔✔Removal of a distributed product for a reason NOT subject to legal action by FDA is
known as:
A. Product recall
B. Stock recovery
C. Market withdrawal
D. Corrective action - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔D
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
