4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
RAC Practice Exam 2025|Actual Exam
Test(MULTIPLE CHOICES) and (RATIONALES)
questions and verified answers |GET IT 100%
ACCURATE!!
Save
Terms in this set (100)
A physician reports to a C. 30 calendar days.
manufacturer that a
patient was hospitalized Serious injury must be reported within 30 days. 21
with acute sepsis after CFR 803.50(a).
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.
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,4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
Under the IDE regulation, C. An unanticipated adverse device effect.
all of the following must
be reported to the The investigator notifies the sponsor and IRB within
sponsor within five 10 days of notification of any unanticipated adverse
working days EXCEPT: effect. 21 CFR 812.150.
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.
When design verification C. Identification of test methods used.
testing is being
performed by a Refer to 820.30(f)
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.
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,4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
Under the statutory A. Adulteration
violations, lack of an
approved PMA for a PMA PMA products introduced into commercial
device that is not exempt distribution without an approval PMA are
and is in commercial considered to be adulterated. FD&C Act 501(f).
distribution is considered
to be:
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
A manufacturer of the C. A custom device being studied for safety and
following must file an IDE effectiveness.
before conducting a
human clinical study? While a custom device may be studied in humans
without an IDE, if its safety and efficacy are being
A. A device in studied in support of commercial marketing, an IDE
commercial distribution must be filed (21 CFR 812.2(c)(7)
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.
https://quizlet.com/1029733929/rac-practice-exam-2025actual-exam-testmultiple-choices-and-rationales-questions-and-verified-answers-get-it-1… 3/62
, 4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
The regulatory affairs A. Preparing criteria for the MDR report.
professional performs all
of the following prior to MDR reporting is a post PMA approval requirement.
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.
Which of the following D. A discussion of benefit and risk considerations.
sections is required in a
PMA? See 21 CFR 814.20(b)(3)(vi).
A. Patent certification
information.
B. A copy of quality
manual.
C. An economic
cost/benefit assessment.
D. A discussion of benefit
and risk considerations.
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RAC Practice Exam 2025|Actual Exam
Test(MULTIPLE CHOICES) and (RATIONALES)
questions and verified answers |GET IT 100%
ACCURATE!!
Save
Terms in this set (100)
A physician reports to a C. 30 calendar days.
manufacturer that a
patient was hospitalized Serious injury must be reported within 30 days. 21
with acute sepsis after CFR 803.50(a).
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.
https://quizlet.com/1029733929/rac-practice-exam-2025actual-exam-testmultiple-choices-and-rationales-questions-and-verified-answers-get-it-1… 1/62
,4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
Under the IDE regulation, C. An unanticipated adverse device effect.
all of the following must
be reported to the The investigator notifies the sponsor and IRB within
sponsor within five 10 days of notification of any unanticipated adverse
working days EXCEPT: effect. 21 CFR 812.150.
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.
When design verification C. Identification of test methods used.
testing is being
performed by a Refer to 820.30(f)
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.
https://quizlet.com/1029733929/rac-practice-exam-2025actual-exam-testmultiple-choices-and-rationales-questions-and-verified-answers-get-it-1… 2/62
,4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
Under the statutory A. Adulteration
violations, lack of an
approved PMA for a PMA PMA products introduced into commercial
device that is not exempt distribution without an approval PMA are
and is in commercial considered to be adulterated. FD&C Act 501(f).
distribution is considered
to be:
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
A manufacturer of the C. A custom device being studied for safety and
following must file an IDE effectiveness.
before conducting a
human clinical study? While a custom device may be studied in humans
without an IDE, if its safety and efficacy are being
A. A device in studied in support of commercial marketing, an IDE
commercial distribution must be filed (21 CFR 812.2(c)(7)
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.
https://quizlet.com/1029733929/rac-practice-exam-2025actual-exam-testmultiple-choices-and-rationales-questions-and-verified-answers-get-it-1… 3/62
, 4/10/25, 12:42 PM RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and (RATIONALES) questions and verified answers |GET…
The regulatory affairs A. Preparing criteria for the MDR report.
professional performs all
of the following prior to MDR reporting is a post PMA approval requirement.
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.
Which of the following D. A discussion of benefit and risk considerations.
sections is required in a
PMA? See 21 CFR 814.20(b)(3)(vi).
A. Patent certification
information.
B. A copy of quality
manual.
C. An economic
cost/benefit assessment.
D. A discussion of benefit
and risk considerations.
https://quizlet.com/1029733929/rac-practice-exam-2025actual-exam-testmultiple-choices-and-rationales-questions-and-verified-answers-get-it-1… 4/62
