1
Device RAC Exam Questions with Answers (100%
Correct Answers)
Which division has primary jurisdiction over a vascular graft with an
antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP Answer: C. CDRH
In this combination of a device and a drug, the primary mode of action
is that of the vascular graft (device). The antibiotic is supportive in this
case.
© 2025 All rights reserved
,2
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
© 2025 All rights reserved
,3
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
© 2025 All rights reserved
, 4
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
© 2025 All rights reserved
Device RAC Exam Questions with Answers (100%
Correct Answers)
Which division has primary jurisdiction over a vascular graft with an
antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP Answer: C. CDRH
In this combination of a device and a drug, the primary mode of action
is that of the vascular graft (device). The antibiotic is supportive in this
case.
© 2025 All rights reserved
,2
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
© 2025 All rights reserved
,3
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
© 2025 All rights reserved
, 4
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
© 2025 All rights reserved
