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Question No 1 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
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Question No 2 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. Answer C
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Question No 3 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 . Answer C
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Question No 4 Under the statutory violations,
lack of an approved PMA for a PMA device that is
not exempt and is in commercial distribution is
considered to be A. Adulteration. B. Improper
use. C. Misbranded. D. Fraudulent. Answer A
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Question No 5 A manufacturer of the following
must file an IDE before conducting a human
clinical study? A. A device in commercial
distribution before 28 May 1976 when used or
investigated in accordance with its indications
in labeling in effect at that time. B. A device
intended solely for veterinary use. C. A custom
device being studied for safety and
effectiveness. D. A device in commercial
distribution before 28 May 1976 when used or
investigated in accordance with its indications
in labeling in effect at that time. And a device
intended solely for veterinary use. Answer C
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Question No 6 The regulatory affairs
professional performs all of the following prior
to submitting a PMA to FDA EXCEPT A Preparing
criteria for the MDR report. B. Preparing a brief
statement of reasons for noncompliance with
regulation. C. Identifying all omissions in PMA
content. D. Reviewing, organizing and checking
adequacy of data pertaining to safety and
efficacy evaluation. Answer A
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Question No 7 Which of the following sections
is required in a PMA? A. Patent certification
information. B. A copy of quality manual. C. An
economic cost/benefit assessment. D. A discussion
of benefit and risk considerations. Answer D
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Question No 8 Subacute toxicity testing should
be performed A. In two rodent species. B. In
one rodent and one non-rodent species. C. For a
minimum of two weeks. D. For a minimum of six
months. Answer B
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Question No 9 What FDA clearances are required
to export a drug approved by FDA? A. Certificate
of Free Sale. B. Customs Tax Stamps. C. No
clearance required. D. FDA receipt for sample
Form-484. Answer C
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Question No 10 Fully quality-assured individual
toxicology reports are not required for
submission of an initial IND application.
However, finalized and fully quality assured
reports should be available to FDA upon request
within what period of the start of the human
study? A 90 days. B. 120 days. C. One year. D.
The final report is only required in the
submission for the NDA Answer B
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