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RAC Sample Test Questions With Complete Solutions
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RAC Sample Test Questions With Complete Solutions
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RAC Sample Test Questions With Complete Solutions. Your company is the initial importer of a medical device.
Which of the following must be true?
A. You must maintain quality assurance files
B. You share responsibility for submission with the other
distributors
C. You must report device malfunctions in an Annual Report
D. You must register your company's establishment with FDA
Correct Answer D. You must register your company's
establishment with FDA
Question Feedback: 21 CFR 807.20(a)(4)—Acts as an initial
importer as defined in § 807.3(g), except that initial importers
may fulfill their listing obligation for any device for which they
did not initiate or develop the specifications for the device or
repackage or relabel the device by submitting the name and
address of the manufacturer. Initial importers shall also be
prepared to submit, when requested by FDA, the proprietary
name, if any, and the common or usual name of each device for
which they are the initial importer. (Amendment published at 77
FR 45941 Aug 2, 2012.)
73. The Medical Device User Fee and Modernization Act of
2002 (MDUFMA) enacted all the following EXCEPT:
A. User fees for premarket reviews
B. Office of Combination Products
C. PDUFA renewal for five additional years
D. New regulatory requirements for reprocessing single-use
devices Correct Answer C. PDUFA renewal for five additional
years
,Question Feedback: PDUFA was initiated/reauthorized under
FDAMA.; Also, the Prescription Drug User Fee Act would not
be renewed under an act written to regulate medical devices.
A blood center has discovered a unit of packed red blood cells
for commercial use previously shipped to a local hospital was
stored inappropriately for four days during the manufacturing
process. The blood center should:
A. Recall the blood product and initiate a blood product
deviation report to CBER within 45 calendar days of discovery
of the deviation.
B. Recall the blood product and initiate a blood product
deviation report to CDRH within 45 calendar days of discovery
of the deviation.
C. Recall the blood product and initiate a blood product
deviation report to CBER within 15 calendar days of discovery
of the deviation
D. Recall the blood product and initiate a blood product
deviation report to CDRH within 15 calendar days of discovery
of the deviation. Correct Answer A. Recall the blood product
and initiate a blood product deviation report to CBER within 45
calendar days of discovery of the deviation.
Question Feedback: CBER is the FDA branch handling biologic
products and the appropriate reporting period is 45 days from
discovery of the manufacturing deviation. Under 21 CFR
606.171, a manufacturer is required to report certain events
associated with the manufacturing, to include testing,
processing, packing, labeling or storage, or with blood or blood
component holding or distribution, which may affect the a
,distributed product's safety, purity or potency. Safety, purity and
potency are defined in 21 CFR 600.3(p), (r) and (s). Under 21
CFR 606.171(c), a manufacturer should submit reports as soon
as possible, but is required to submit reports at a date not to
exceed 45 calendar days from the date of discovery of
information reasonably suggesting a reportable event has
occurred.
A Class II device with electrical components was subjected to
extensive standardized testing such as the International
Electrotechnical Commission (IEC) series (recognized
conformance standard). The tests were conducted by a third
party. Which route of submission is the most suitable for this
device?
A. Traditional 510(k)
B. Special 510(k)
C. Abbreviated 510(k)
D. PMA Correct Answer C. Abbreviated 510(k)
Question Feedback: A manufacturer has the option to submit an
Abbreviated 510(k) when FDA has recognized relevant
consensus standards applicable to the device. This Abbreviated
510(k) will include a declaration of conformity to the recognized
consensus standards, and this declaration, in many cases, should
eliminate the need to review actual test data for those aspects of
the device addressed by the standards, thus the review will be
more efficient.
A company has a 510(k) device and wants to expand its
indications for use. The device can be used for the new
indication, which includes a new and distinguishable patient
, population, with only minor changes to the device's
specifications. Which actions need to take place before
marketing the device for the new indication:
A. A new 510k needs to be submitted with appropriate testing
for the new indication
B. Since the device specification changes are minor, a special
510k can be submitted
C. The device can be marketed right away and the change
described in the Annual Report
D. The device can be marketed after submission of labeling
change Correct Answer A. A new 510k needs to be submitted
with appropriate testing for the new indication
Question Feedback: A new indication for use requires a new
510(k) clearance.
A company has a new blood pressure medication, NOSTRESS.
Clinical trials are completed and demonstrate similar safety and
efficacy to drugs currently on the market. Clinical data are ready
for submission to FDA. Chemistry, manufacturing and controls
data are not ready, but will be in two months. What is the fastest
NDA filing method?
A. Submit NDA as a rolling review
B. Wait until CMC data are ready to submit
C. File the NDA with the clinical data and update the CMC data
in the four-month update
D. Request Fast Track designation Correct Answer B. Wait
until CMC data are ready to submit
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