DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)DEVICE RAC EXAM QUESTIONS AND ANSWERS (GRADED A)Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mo...
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
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) - 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 - 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 - ANSWER-A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - 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 - 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. - 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 - 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.
C. You have changed the package of the device.
D. None of the above. - ANSWER-D
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