Terms in this set (69)
Quiz____?
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 -
Answer✓✓
C
Quiz____?
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
1
, 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) -
Answer✓✓
A
Quiz____?
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 -
Answer✓✓
C
Quiz____?
2
, 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 -
Answer✓✓
A
Quiz____?
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers -
Answer✓✓
D
3
, Quiz____?
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
C. 30 calendar days
D. The next quarterly or annual report -
Answer✓✓
C
Quiz____?
If a device failure is 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. -
Answer✓✓
A
4
Quiz____?
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 -
Answer✓✓
C
Quiz____?
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
1
, 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) -
Answer✓✓
A
Quiz____?
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 -
Answer✓✓
C
Quiz____?
2
, 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 -
Answer✓✓
A
Quiz____?
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers -
Answer✓✓
D
3
, Quiz____?
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
C. 30 calendar days
D. The next quarterly or annual report -
Answer✓✓
C
Quiz____?
If a device failure is 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. -
Answer✓✓
A
4
