DEVICE RAC EVALUATION EXAM 2026/2027 QUESTIONS
AND SOLUTIONS RATED A+
✔✔According to the QSR, personnel involved in the design, manufacture, distribution,
servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their area of responsibility
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
✔✔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 following are considered General Controls under the FD&C Act except:
A) Establishment Registration
B) Pre-market Approval Application
C) Quality System Regulation
D) Device Listing - ✔✔B
✔✔If your firm commercially distributes a Class III device that is subject to PMA
requirements without an approved Pre-market Approval Application, what is the
statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - ✔✔A
✔✔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
✔✔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
, firm sterilizes that are commercially available in the U.S. Which of the following
responses is correct?
A) Contact FDA to request a large number of Device Listing forms and assign a
member of your staff to begin completing a form for each device your firm sterilizes.
B) Exclude devices from foreign manufacturers from the list being prepared above.
C) Find something else to worry about, contract sterilizers are not required to submit
Device Listing forms for the devices they manufacture. - ✔✔C
✔✔The MDR regulations require that which of the following groups are not required to
notify FDA if they become aware of information required to be reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities - ✔✔B
✔✔Which of the following conditions may be expected to lead to a field recall action?
A) Market Withdrawal for correction or removal of distributed devices involving no
violation or minor violation of FD&C Act
B) Physical removal of device from point of use to other location for repair, modification,
adjustment, relabeling, destruction, or inspection
C) Stock Recovery of a device has not left direct control of manufacturer
D) Routine servicing - ✔✔B
✔✔When FDA declares a device from a 510(k) application to be Not Substantially
Equivalent (NSE) and requires a PMA. What is the most practicable first option for a
company at this stage?
A) File a PMA immediately
B) Petition CDRH to downclassify the device
C) Resubmit a 510(k) with new data to demonstrate the device is at least as safe and
effective as the predicate.
D) Submit this product for approval in Europe - ✔✔C
✔✔The Medical Device User Fee and Modernization Act of 2002 enacted all the
following except:
A) User fees for premarket reviews
B) Office of Combination Products
C) Prescription Drug User Fee Act (PDUFA) renewal for five additional years - ✔✔C
✔✔What is a major difference between an HDE and a PMA application?
A) Application form and content
B) Labeling requirements
C) Supplemental applications
AND SOLUTIONS RATED A+
✔✔According to the QSR, personnel involved in the design, manufacture, distribution,
servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their area of responsibility
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
✔✔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 following are considered General Controls under the FD&C Act except:
A) Establishment Registration
B) Pre-market Approval Application
C) Quality System Regulation
D) Device Listing - ✔✔B
✔✔If your firm commercially distributes a Class III device that is subject to PMA
requirements without an approved Pre-market Approval Application, what is the
statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - ✔✔A
✔✔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
✔✔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
, firm sterilizes that are commercially available in the U.S. Which of the following
responses is correct?
A) Contact FDA to request a large number of Device Listing forms and assign a
member of your staff to begin completing a form for each device your firm sterilizes.
B) Exclude devices from foreign manufacturers from the list being prepared above.
C) Find something else to worry about, contract sterilizers are not required to submit
Device Listing forms for the devices they manufacture. - ✔✔C
✔✔The MDR regulations require that which of the following groups are not required to
notify FDA if they become aware of information required to be reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities - ✔✔B
✔✔Which of the following conditions may be expected to lead to a field recall action?
A) Market Withdrawal for correction or removal of distributed devices involving no
violation or minor violation of FD&C Act
B) Physical removal of device from point of use to other location for repair, modification,
adjustment, relabeling, destruction, or inspection
C) Stock Recovery of a device has not left direct control of manufacturer
D) Routine servicing - ✔✔B
✔✔When FDA declares a device from a 510(k) application to be Not Substantially
Equivalent (NSE) and requires a PMA. What is the most practicable first option for a
company at this stage?
A) File a PMA immediately
B) Petition CDRH to downclassify the device
C) Resubmit a 510(k) with new data to demonstrate the device is at least as safe and
effective as the predicate.
D) Submit this product for approval in Europe - ✔✔C
✔✔The Medical Device User Fee and Modernization Act of 2002 enacted all the
following except:
A) User fees for premarket reviews
B) Office of Combination Products
C) Prescription Drug User Fee Act (PDUFA) renewal for five additional years - ✔✔C
✔✔What is a major difference between an HDE and a PMA application?
A) Application form and content
B) Labeling requirements
C) Supplemental applications
