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DEVICE RAC EXAM 2026 WITH
QUESTIONS AND ANSWERS
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 - correct answer-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)
C. Traditional 510(k)
D. De novo 510(k) - correct answer-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
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C. Misbranded
D. Fraudulent - correct answer-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.
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
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - correct answer-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
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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
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. - correct answer-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 - correct
answer-C
DEVICE RAC EXAM 2026 WITH
QUESTIONS AND ANSWERS
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 - correct answer-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)
C. Traditional 510(k)
D. De novo 510(k) - correct answer-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
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C. Misbranded
D. Fraudulent - correct answer-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.
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
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - correct answer-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
, 3 |Page
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
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. - correct answer-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 - correct
answer-C
