DEVICE RAC TEST PAPER 2026/2027 QUESTIONS AND
SOLUTIONS RATED A+
✔✔If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper use by the end user, which of the
following typically occurs?
A. The labeling is revised
B. The product is recalled
C. The product is redesigned
D. A "Dear Doctor" letter is issued - ✔✔A. The labeling is revised
The labeling should provide appropriate information for proper use of the product.
✔✔Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C
Act before marketing a device:
A. Makes the product misbranded under Section 502 of the Act
B. Introduces an unapproved product into interstate commerce
C. Causes the product to be mislabeled
D. None of the above - ✔✔A. Makes the product misbranded under Section 502 of the
Act
The product is considered to be misbranded if the product is not cleared through the
510(k) process. See the federal FD&C Act, Section 502(o). Note: A product is
considered adulterated if the product requires an approved PMA but does not have one.
✔✔Under QSR, device design requirements MUST meet needs of:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ✔✔D. Patient and user
QSR requires design input as defined in 21 CFR 820. 30 (c) meet the needs of both the
patient and user.
✔✔Under IDE regulation, all must be reported to sponsor within five working days
EXCEPT:
A. Deviation from investigational plan
B. Withdrawal of IRB approval
C. Unanticipated adverse device effect
D. Use of a device without informed consent - ✔✔C. An unanticipated adverse device
effect
,Regulations
An investigator shall notify the sponsor and IRB of any deviation from the investigational
plan to protect the life or physical well-being of a subject in an emergency. Such notice
shall be given as soon as possible, but in no event later than 5 working days after the
emergency occurred.
If an investigator uses a device without obtaining informed consent, the investigator
shall report such use to the sponsor and the reviewing IRB within 5 working days after
the use occurs.
Withdrawal of IRB Approval
A sponsor shall notify FDA and all reviewing IRB's /investigators of any withdrawal of
IRB approval within 5 working days after receipt of the withdrawal of approval.
An investigator shall report to the sponsor, within 5 working days, a withdrawal of IRB
approval
An investigator shall submit to the sponsor and IRB a report of any unanticipated
adverse device effect occurring as soon as possible, but in no event later than 10
working days after the investigator first learns of the effect.
✔✔Which mfgers must register their mfging facility with FDA?
A. Component mfgers who sell only to device mfger using their components
B. Domestic (US) contract mfgers who do not directly distribute the final product to the
market
C. Domestic mfger of device being investigated under an IDE
D. Foreign mfgers shipping devices into US for sale in US - ✔✔D. Foreign mfgers
shipping devices into the US for sale in the US
All foreign mfgers making devices distributed in the US must register with FDA.
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ✔✔D. Component manufacturers
Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).
✔✔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 - ✔✔A. Establishment registration
by the foreign manufacturer
The initial importers must register, but not all foreign manufacturers are required to
register only if sold in the US
✔✔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 - ✔✔B. New Class II devices
✔✔Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB
B. Protecting the rights, safety and welfare of study subjects
C. Controlling the test materials under investigation during the study
D. Keeping all unused test material at their facility until the drug/device is approved by
FDA - ✔✔D. Keeping all unused test material at their facility until the drug/device is
approved by FDA
✔✔All of the following are considered General Controls under the Food, Drug &
Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B. Premarket approval application
Premarket approval application (PMA) is not a general control.
✔✔According to the Quality System Regulation, 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 - ✔✔C. Maintenance must be
performed at least annually
QSR does not specify "annually":
SOLUTIONS RATED A+
✔✔If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper use by the end user, which of the
following typically occurs?
A. The labeling is revised
B. The product is recalled
C. The product is redesigned
D. A "Dear Doctor" letter is issued - ✔✔A. The labeling is revised
The labeling should provide appropriate information for proper use of the product.
✔✔Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C
Act before marketing a device:
A. Makes the product misbranded under Section 502 of the Act
B. Introduces an unapproved product into interstate commerce
C. Causes the product to be mislabeled
D. None of the above - ✔✔A. Makes the product misbranded under Section 502 of the
Act
The product is considered to be misbranded if the product is not cleared through the
510(k) process. See the federal FD&C Act, Section 502(o). Note: A product is
considered adulterated if the product requires an approved PMA but does not have one.
✔✔Under QSR, device design requirements MUST meet needs of:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ✔✔D. Patient and user
QSR requires design input as defined in 21 CFR 820. 30 (c) meet the needs of both the
patient and user.
✔✔Under IDE regulation, all must be reported to sponsor within five working days
EXCEPT:
A. Deviation from investigational plan
B. Withdrawal of IRB approval
C. Unanticipated adverse device effect
D. Use of a device without informed consent - ✔✔C. An unanticipated adverse device
effect
,Regulations
An investigator shall notify the sponsor and IRB of any deviation from the investigational
plan to protect the life or physical well-being of a subject in an emergency. Such notice
shall be given as soon as possible, but in no event later than 5 working days after the
emergency occurred.
If an investigator uses a device without obtaining informed consent, the investigator
shall report such use to the sponsor and the reviewing IRB within 5 working days after
the use occurs.
Withdrawal of IRB Approval
A sponsor shall notify FDA and all reviewing IRB's /investigators of any withdrawal of
IRB approval within 5 working days after receipt of the withdrawal of approval.
An investigator shall report to the sponsor, within 5 working days, a withdrawal of IRB
approval
An investigator shall submit to the sponsor and IRB a report of any unanticipated
adverse device effect occurring as soon as possible, but in no event later than 10
working days after the investigator first learns of the effect.
✔✔Which mfgers must register their mfging facility with FDA?
A. Component mfgers who sell only to device mfger using their components
B. Domestic (US) contract mfgers who do not directly distribute the final product to the
market
C. Domestic mfger of device being investigated under an IDE
D. Foreign mfgers shipping devices into US for sale in US - ✔✔D. Foreign mfgers
shipping devices into the US for sale in the US
All foreign mfgers making devices distributed in the US must register with FDA.
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ✔✔D. Component manufacturers
Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).
✔✔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 - ✔✔A. Establishment registration
by the foreign manufacturer
The initial importers must register, but not all foreign manufacturers are required to
register only if sold in the US
✔✔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 - ✔✔B. New Class II devices
✔✔Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB
B. Protecting the rights, safety and welfare of study subjects
C. Controlling the test materials under investigation during the study
D. Keeping all unused test material at their facility until the drug/device is approved by
FDA - ✔✔D. Keeping all unused test material at their facility until the drug/device is
approved by FDA
✔✔All of the following are considered General Controls under the Food, Drug &
Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B. Premarket approval application
Premarket approval application (PMA) is not a general control.
✔✔According to the Quality System Regulation, 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 - ✔✔C. Maintenance must be
performed at least annually
QSR does not specify "annually":
