DEVICE RAC ACTUAL EXAM WITH
DETAILED QUESTIONS AND CORRECT
ANSWERS WITH DETAILED RATIONALES
GRADED A+
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) Correct 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 Correct 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 Correct 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 Correct 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
Correct 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. Correct 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.
DETAILED QUESTIONS AND CORRECT
ANSWERS WITH DETAILED RATIONALES
GRADED A+
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) Correct 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 Correct 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 Correct 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 Correct 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
Correct 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. Correct 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.
