DEVICE RAC Exam Questions and
Answers
1. Which division has primary jurisdiction over a vascular
graft with an antibi- otic based on primary mode of action?
A. CDER B. CBER C. CDRH
D. OCP: C. CDRH
In this combination of a device and a drug, the primary mode of
action is that of the vascular graft (device). The antibiotic is
supportive in this case.
2. A company wants to modify its legally marketed device
such that the mod- ification 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): A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally
marketed device is being made that relies on compliance with
design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to
process special 510(k)s within 30 days of receipt. See the CDRH
guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence
in Premarket Notifications.
3. 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: C. Misbranded
A marketed device that needs a 510(k) for commercialization but
failed to comply with the requirements is considered to be
Misbranded. See the FD&C Act, 502(o).
4. A company's competitor is marketing a Class II suture
which dissolves dur- ing 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: A. This requires a new
510(k) since significant change in product instructions might affect
efficacy.
A new intended use requires a 510(k) clearance.
5. 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: C. 30 calendar days
, Serious injury must be reported within 30 days even if it is
expected and stated in the IFU
6. A handling and storage system for medical devices must
always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine
products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf
life: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21
CFR 820.150(b).
7. You have modified your 510(k) 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.
Answers
1. Which division has primary jurisdiction over a vascular
graft with an antibi- otic based on primary mode of action?
A. CDER B. CBER C. CDRH
D. OCP: C. CDRH
In this combination of a device and a drug, the primary mode of
action is that of the vascular graft (device). The antibiotic is
supportive in this case.
2. A company wants to modify its legally marketed device
such that the mod- ification 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): A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally
marketed device is being made that relies on compliance with
design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to
process special 510(k)s within 30 days of receipt. See the CDRH
guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence
in Premarket Notifications.
3. 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: C. Misbranded
A marketed device that needs a 510(k) for commercialization but
failed to comply with the requirements is considered to be
Misbranded. See the FD&C Act, 502(o).
4. A company's competitor is marketing a Class II suture
which dissolves dur- ing 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: A. This requires a new
510(k) since significant change in product instructions might affect
efficacy.
A new intended use requires a 510(k) clearance.
5. 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: C. 30 calendar days
, Serious injury must be reported within 30 days even if it is
expected and stated in the IFU
6. A handling and storage system for medical devices must
always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine
products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf
life: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21
CFR 820.150(b).
7. You have modified your 510(k) 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.
