Device RAC Exam Questions and Answers 100% Accurate
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Device RAC
Institution
Device RAC
Device RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% AccurateDevice RAC Exam Questions and Answers 100% Accurate
Which division has primary jurisdiction over a vascular graft with an antibiotic based on pri...
Which division has 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. 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.
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. 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.
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. 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).
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. This requires a new
510(k) since significant change in product instructions might affect efficacy.
A new intended use requires a 510(k) clearance.
, 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. 30 calendar days
Serious injury must be reported within 30 days even if it is expected and
stated in the IFU
The QSR calls for finished device mfgers to carry out all of the following
EXCEPT:
A. Quality audits conducted by individuals who don't have direct
responsibility for operation being audited
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
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