DEVICE RAC EXAM COMPREHENSIVE
QUESTIONS WITH MULTIPLE CHOICES
|VERIFIED & REVISED ANSWERS (NEW) 2026
Save
Terms in this set (69)
Which division would have primary C
jurisdiction over a vascular graft
with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
A company wants to modify its A
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)
,Under the statutory violations, C
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
A company's competitor is A
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
, Which of the following is exempt D
from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
A physician reports to a C
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
If a device failure is occurring with A
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.
QUESTIONS WITH MULTIPLE CHOICES
|VERIFIED & REVISED ANSWERS (NEW) 2026
Save
Terms in this set (69)
Which division would have primary C
jurisdiction over a vascular graft
with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
A company wants to modify its A
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)
,Under the statutory violations, C
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
A company's competitor is A
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
, Which of the following is exempt D
from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
A physician reports to a C
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
If a device failure is occurring with A
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.
