DEVICE RAC COMPREHENSIVE CORRECT SET
QUESTIONS AND ANSWERS SURE A+
✔✔Design Control "verification" requires which of the following:
A) Product design meets user needs
B) Process produces product that meets predetermined specs
C) Product design meets specified requirements
D) Product design meets intended use requirements - ✔✔C) Product design meets
specified requirements
✔✔According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
D) The performance requirements that the product must meet - ✔✔D) The performance
requirements that the product must meet
✔✔According to the QSR, Design Outputs contain the following:
A) Device Master Record (DMR)
B) The documentation from the last phase of the complete Design Control process
C) Test reports that support the Design Inputs met
D) All packaging and labeling associated with finished device
E) A and D above - ✔✔E) A and D above
NOT RAC TEST STYLE QUESTION
✔✔According to the QSR, Quality Audits must accomplish the following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
, C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above - ✔✔E) B and C above
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
✔✔According to QSR, personnel involved in design, mfg, distribution, servicing, and
reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training annually in their area
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not perform their job correctly -
✔✔D) Be made aware of defects which may occur if they do not perform their job
correctly
✔✔According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
D) All of the above - ✔✔D) All of the above
✔✔If your firm commercially distributes a Class III device subject to PMA without an
approved PMA, what is the statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - ✔✔A) Adulteration
✔✔Pre-market Notification Requirements would apply to a device that is:
A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use - ✔✔A) Substantially equivalent to a pre-amendment
device
✔✔You have just been hired as Director of Regulatory Affairs at a contract sterilizer
from a similar position at a surgical instrument manufacturer and are reviewing your
firms' records. You haven't come across any device listing forms for the devices your
QUESTIONS AND ANSWERS SURE A+
✔✔Design Control "verification" requires which of the following:
A) Product design meets user needs
B) Process produces product that meets predetermined specs
C) Product design meets specified requirements
D) Product design meets intended use requirements - ✔✔C) Product design meets
specified requirements
✔✔According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
D) The performance requirements that the product must meet - ✔✔D) The performance
requirements that the product must meet
✔✔According to the QSR, Design Outputs contain the following:
A) Device Master Record (DMR)
B) The documentation from the last phase of the complete Design Control process
C) Test reports that support the Design Inputs met
D) All packaging and labeling associated with finished device
E) A and D above - ✔✔E) A and D above
NOT RAC TEST STYLE QUESTION
✔✔According to the QSR, Quality Audits must accomplish the following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
, C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above - ✔✔E) B and C above
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
✔✔According to QSR, personnel involved in design, mfg, distribution, servicing, and
reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training annually in their area
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not perform their job correctly -
✔✔D) Be made aware of defects which may occur if they do not perform their job
correctly
✔✔According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
D) All of the above - ✔✔D) All of the above
✔✔If your firm commercially distributes a Class III device subject to PMA without an
approved PMA, what is the statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - ✔✔A) Adulteration
✔✔Pre-market Notification Requirements would apply to a device that is:
A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use - ✔✔A) Substantially equivalent to a pre-amendment
device
✔✔You have just been hired as Director of Regulatory Affairs at a contract sterilizer
from a similar position at a surgical instrument manufacturer and are reviewing your
firms' records. You haven't come across any device listing forms for the devices your
