1 | Page
DEVICE RAC EXAM Questions and
Answers Latest 2026
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)
C. Traditional 510(k)
D. De novo 510(k) Ans: A
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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.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change Ans: A
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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 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.
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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
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. Ans: D
According to the QSR, when an investigation of a
complaint is conducted all of the following are
© 2025 All rights reserved
DEVICE RAC EXAM Questions and
Answers Latest 2026
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)
C. Traditional 510(k)
D. De novo 510(k) Ans: A
© 2025 All rights reserved
, 2 | Page
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.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change Ans: A
© 2025 All rights reserved
, 3 | Page
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 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.
© 2025 All rights reserved
, 4 | Page
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
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. Ans: D
According to the QSR, when an investigation of a
complaint is conducted all of the following are
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