PAGE |1
DEVICE RAC EXAM QUESTIONS AND
VERIFIED ANSWERS| A+ GRADED
Which division would have primary jurisdiction over a vascular graft
with an antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
Ans: C
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)
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C. Traditional 510(k)
D. De novo 510(k)
Ans: A
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
Ans: C
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.
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B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change
Ans: A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Ans: D
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
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Ans: C
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.
Ans: A
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 receipt and transfer of product
D. Environmentally controlled areas for products with shelf life
Ans: C
DEVICE RAC EXAM QUESTIONS AND
VERIFIED ANSWERS| A+ GRADED
Which division would have primary jurisdiction over a vascular graft
with an antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
Ans: C
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)
, Page |2
C. Traditional 510(k)
D. De novo 510(k)
Ans: A
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
Ans: C
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.
, Page |3
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change
Ans: A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Ans: D
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
, Page |4
Ans: C
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.
Ans: A
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 receipt and transfer of product
D. Environmentally controlled areas for products with shelf life
Ans: C
