3/11/26, 4:12 PM DEVICE RAC EXAM QUESTIONS
DEVICE RAC EXAM QUESTIONS || Most Recent Exam Actual
Complete Real Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ | Guaranteed Success!! Newest
Exam | Just Released 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
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)
A
s/ 1/25
,3/11/26, 4:12 PM DEVICE RAC EXAM QUESTIONS
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
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
A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
D
s/ 2/25
, 3/11/26, 4:12 PM DEVICE RAC EXAM QUESTIONS
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
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.
A
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.
D
s/ 3/25
DEVICE RAC EXAM QUESTIONS || Most Recent Exam Actual
Complete Real Exam Questions And Correct Answers (Verified
Answers) Already Graded A+ | Guaranteed Success!! Newest
Exam | Just Released 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
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)
A
s/ 1/25
,3/11/26, 4:12 PM DEVICE RAC EXAM QUESTIONS
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
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
A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
D
s/ 2/25
, 3/11/26, 4:12 PM DEVICE RAC EXAM QUESTIONS
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
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.
A
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.
D
s/ 3/25
