RAC Medical Devices Exam (2025)
|COMPREHENSIVE QUESTIONS
AND VERIFIED ANSWERS |100%
ACCURATE ANSWERS | ALREADY
GRADED A+
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Terms in this set (69)
,Which division C
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
,A company wants A
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)
, Under the C
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
|COMPREHENSIVE QUESTIONS
AND VERIFIED ANSWERS |100%
ACCURATE ANSWERS | ALREADY
GRADED A+
Save
Terms in this set (69)
,Which division C
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
,A company wants A
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)
, Under the C
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
