DEVICE RAC Exam 2025–2026 –
Accurate and Verified Q&A from the
Real Exam – Regulatory Affairs
Certification
, 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 ANSWERS-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 ANSWERS-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 - CORRECT ANSWERS-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 ANSWERS-A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - CORRECT ANSWERS-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
Accurate and Verified Q&A from the
Real Exam – Regulatory Affairs
Certification
, 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 ANSWERS-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 ANSWERS-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 - CORRECT ANSWERS-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 ANSWERS-A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - CORRECT ANSWERS-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
