DEVICE RAC EXAM QUESTIONS / ACTUAL TEST
QUESTIONS WITH DETAILED VERIFIED ANSWERS
/ ALREADY GRADED A
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, failure C
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 marketing A
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.
, A handling and storage system for C
medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for
release and quarantine products
C. Procedures for receipt and
transfer of product
D. Environmentally controlled areas
for products with shelf life
You have modified your 510(k) D
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.
According to the QSR, when an C
investigation of a complaint is
conducted all of the following are
requirements for inclusion in the
record of the investigation EXCEPT:
A. The dates and results of the
investigation
B. The nature and details of the
complaint
C. Changes in procedures correcting
quality problems
D. Any reply to the complainant
QUESTIONS WITH DETAILED VERIFIED ANSWERS
/ ALREADY GRADED A
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, failure C
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 marketing A
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.
, A handling and storage system for C
medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for
release and quarantine products
C. Procedures for receipt and
transfer of product
D. Environmentally controlled areas
for products with shelf life
You have modified your 510(k) D
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.
According to the QSR, when an C
investigation of a complaint is
conducted all of the following are
requirements for inclusion in the
record of the investigation EXCEPT:
A. The dates and results of the
investigation
B. The nature and details of the
complaint
C. Changes in procedures correcting
quality problems
D. Any reply to the complainant
