DEVICE RAC EXAM MULTIPLE
CHOICE QUESTIONS WITH
ANSWERS
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 - correct answer ✔C
||| ||| ||| ||| |||
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 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) - correct answer ✔A
||| ||| ||| ||| ||| ||| |||
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 - correct answer ✔C
||| ||| ||| ||| |||
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 - correct answer ✔A
||| ||| ||| ||| ||| ||| ||| ||| |||
Which of the following is exempt from GMP/QSR regulations?
||| ||| ||| ||| ||| ||| ||| |||
A. Remanufacturers
|||
B. Custom device manufacturers
||| ||| |||
C. Repackagers
|||
D. Component manufacturers - correct answer ✔D
||| ||| ||| ||| ||| |||
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 - correct answer ✔C
||| ||| ||| ||| ||| ||| ||| ||| ||| |||
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. - correct answer ✔A
||| ||| ||| ||| ||| ||| ||| ||| ||| |||
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 receipt and transfer of product
||| ||| ||| ||| ||| ||| |||
D. Environmentally controlled areas for products with shelf life - correct
||| ||| ||| ||| ||| ||| ||| ||| ||| ||| |||
answer ✔C |||
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.
||| ||| ||| ||| ||| ||| ||| ||| |||
CHOICE QUESTIONS WITH
ANSWERS
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 - correct answer ✔C
||| ||| ||| ||| |||
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 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) - correct answer ✔A
||| ||| ||| ||| ||| ||| |||
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 - correct answer ✔C
||| ||| ||| ||| |||
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 - correct answer ✔A
||| ||| ||| ||| ||| ||| ||| ||| |||
Which of the following is exempt from GMP/QSR regulations?
||| ||| ||| ||| ||| ||| ||| |||
A. Remanufacturers
|||
B. Custom device manufacturers
||| ||| |||
C. Repackagers
|||
D. Component manufacturers - correct answer ✔D
||| ||| ||| ||| ||| |||
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 - correct answer ✔C
||| ||| ||| ||| ||| ||| ||| ||| ||| |||
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. - correct answer ✔A
||| ||| ||| ||| ||| ||| ||| ||| ||| |||
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 receipt and transfer of product
||| ||| ||| ||| ||| ||| |||
D. Environmentally controlled areas for products with shelf life - correct
||| ||| ||| ||| ||| ||| ||| ||| ||| ||| |||
answer ✔C |||
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.
||| ||| ||| ||| ||| ||| ||| ||| |||
