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US RAC Practice Exam Questions With Correct Explanations Update
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. -Explanation:
B. There are no 15 day reports included in MDR regulations. 15 Day reports are required b by drug
reporting regulations.
The correct answer is: C
Under the IDE regulation, all of the following must be reported to the sponsor within five working days
EXCEPT:
A. A deviation from the investigational plan.
B. Withdrawal of IRB approval.
C. An unanticipated adverse device effect.
D. Use of a device without informed consent. -Explanation:
B. Withdrawal of IRB approval is reported within five days.
The correct answer is C.
When design verification testing is being performed by a manufacturer, which element is NOT included
as a potential requirement under device design verification section of the QSR?
A. Identification of the design
B. Software validation
C. Identification of test methods used.
D. Name of individuals performing the testing . -Explanation:
B. Software validation is generally included in design validation, not verification (820.30 (g))
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