DEVICE RAC FINAL EXAM SCRIPT 2026
QUESTIONS WITH ANSWERS FULLY REVIEWED
● A company wants to modify its legally marketed device such that the
modification does not affect the intended use or alter the fundamental
scientific technology of the device. If the design outputs of the modified
device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k). Answer: A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed
device is being made that relies on compliance with design controls,
including design validation. The incentive provided for manufacturers to
choose this option is that ODE intends to process special 510(k)s within
30 days of receipt. See the CDRH guidance published in 1998 entitled
The New 510(k) Paradigm - Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications.
,● Under the statutory violations, failure to meet 510(k) requirements for
a device that is required to have a 510(k) and is in commercial
distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent. Answer: C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed
to comply with the requirements is considered to be Misbranded. See the
FD&C Act, 502(o).
● A company's competitor is marketing a Class II suture which dissolves
during the third week of use. The company's current product has to be
removed by a physician. However, a change in weaving configuration
gives this product the same dissolving time as the competitor's. When
can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product
instructions might affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
,D. After submission of labeling change. Answer: A. This requires a new
510(k) since significant change in product instructions might affect
efficacy.
A new intended use requires a 510(k) clearance.
● A physician reports to a manufacturer that a patient was hospitalized
with acute sepsis after treatment with an approved device. This side
effect is not listed in the package insert. This event must be reported by
the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report. Answer: C. 30 calendar days
Serious injury must be reported within 30 days even if it is expected and
stated in the IFU
● A handling and storage system for medical devices must always
include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
, C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf life.
Answer: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR
820.150(b).
● You have modified your 510(k) cleared device with a special 510(k).
In which of the following cases would you need to create a new listing
for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above.. Answer: D. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be
submitted for each device or device class listed with the FDA. Devices
having variations in physical characteristics such as size, package,
shape, color or composition should be considered to be one device:
Provided, The variation does not change the function or intended use of
the device.
QUESTIONS WITH ANSWERS FULLY REVIEWED
● A company wants to modify its legally marketed device such that the
modification does not affect the intended use or alter the fundamental
scientific technology of the device. If the design outputs of the modified
device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k). Answer: A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed
device is being made that relies on compliance with design controls,
including design validation. The incentive provided for manufacturers to
choose this option is that ODE intends to process special 510(k)s within
30 days of receipt. See the CDRH guidance published in 1998 entitled
The New 510(k) Paradigm - Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications.
,● Under the statutory violations, failure to meet 510(k) requirements for
a device that is required to have a 510(k) and is in commercial
distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent. Answer: C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed
to comply with the requirements is considered to be Misbranded. See the
FD&C Act, 502(o).
● A company's competitor is marketing a Class II suture which dissolves
during the third week of use. The company's current product has to be
removed by a physician. However, a change in weaving configuration
gives this product the same dissolving time as the competitor's. When
can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product
instructions might affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
,D. After submission of labeling change. Answer: A. This requires a new
510(k) since significant change in product instructions might affect
efficacy.
A new intended use requires a 510(k) clearance.
● A physician reports to a manufacturer that a patient was hospitalized
with acute sepsis after treatment with an approved device. This side
effect is not listed in the package insert. This event must be reported by
the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report. Answer: C. 30 calendar days
Serious injury must be reported within 30 days even if it is expected and
stated in the IFU
● A handling and storage system for medical devices must always
include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
, C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf life.
Answer: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR
820.150(b).
● You have modified your 510(k) cleared device with a special 510(k).
In which of the following cases would you need to create a new listing
for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above.. Answer: D. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be
submitted for each device or device class listed with the FDA. Devices
having variations in physical characteristics such as size, package,
shape, color or composition should be considered to be one device:
Provided, The variation does not change the function or intended use of
the device.
