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RAC 2016 US RAC Practice Exam Questions and Answers (Latest Update 2025)
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RAC 2016 US RAC Practice Exam Questions and Answers (Latest Update 2025)
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RAC 2016 US RAC Practice ExamQuestions and Answers (Latest Update
2025)
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. - Correct Answer ✅
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.
,RAC 2016 US RAC Practice Exam
Questions and Answers (Latest Update
2025)
C. An unanticipated adverse device effect.
D. Use of a device without informed consent. - Correct
Answer ✅ 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 . - Correct
Answer ✅ Explanation:
B. Software validation is generally included in design
validation, not verification (820.30 (g)).
,RAC 2016 US RAC Practice Exam
Questions and Answers (Latest Update
2025)
The Correct Answer is C.
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. - Correct Answer ✅ Explanation:
D. PMA products introduced into commercial distribution
without an approval PMA are considered to be adulterated.
FD&C Act 501 (f).
The Correct Answer is A.
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.
, RAC 2016 US RAC Practice Exam
Questions and Answers (Latest Update
2025)
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. - Correct Answer ✅ Explanation:
C. While a custom device may be studied in humans without
an IDE, if its safety and efficacy are being studied
in support of commercial marketing, an IDE must be file (21
CFR 812.2(c)(7))
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.
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