10/18/24, 8:58 AM DEVICE RAC EXAM QUESTIONS/DEVICE RAC Full Solution Pack Exams 2024-2025 update comprehensive questions with…
DEVICE RAC EXAM QUESTIONS/DEVICE RAC
Full Solution Pack Exams 2024-2025 update
comprehensive questions with complete
solution | get it right !!
Terms in this set (69)
Which division would C
have primary jurisdiction
over a vascular graft with
an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
,10/18/24, 8:58 AM DEVICE RAC EXAM QUESTIONS/DEVICE RAC Full Solution Pack Exams 2024-2025 update comprehensive questions with…
A company wants to A
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)
Under the statutory C
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
,10/18/24, 8:58 AM DEVICE RAC EXAM QUESTIONS/DEVICE RAC Full Solution Pack Exams 2024-2025 update comprehensive questions with…
A company's competitor A
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
Which of the following is D
exempt from GMP/QSR
regulations?
A. Remanufacturers
B. Custom device
manufacturers
C. Repackagers
D. Component
manufacturers
, 10/18/24, 8:58 AM DEVICE RAC EXAM QUESTIONS/DEVICE RAC Full Solution Pack Exams 2024-2025 update comprehensive questions with…
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 A
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.
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