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RAC Practice Exam Questions and
Answers Latest 2026
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. Ans: C. 30
calendar days.
Serious injury must be reported within 30 days. 21 CFR
803.50(a).
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.
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D. Use of a device without informed consent. Ans: C. An
unanticipated adverse device effect.
The investigator notifies the sponsor and IRB within 10
days of notification of any unanticipated adverse effect.
21 CFR 812.150.
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. Ans: C.
Identification of test methods used.
Refer to 820.30(f)
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
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D. Fraudulent Ans: A. Adulteration
PMA products introduced into commercial distribution
without an approval PMA are considered to be
adulterated. FD&C Act 501(f).
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. Ans: C. A custom
device being studied for safety and effectiveness.
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 filed
(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.
© 2025 All rights reserved
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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. Ans: A.
Preparing criteria for the MDR report.
MDR reporting is a post PMA approval requirement.
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. Ans:
D. A discussion of benefit and risk considerations.
See 21 CFR 814.20(b)(3)(vi).
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.
© 2025 All rights reserved
RAC Practice Exam Questions and
Answers Latest 2026
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. Ans: C. 30
calendar days.
Serious injury must be reported within 30 days. 21 CFR
803.50(a).
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.
© 2025 All rights reserved
, 2 | Page
D. Use of a device without informed consent. Ans: C. An
unanticipated adverse device effect.
The investigator notifies the sponsor and IRB within 10
days of notification of any unanticipated adverse effect.
21 CFR 812.150.
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. Ans: C.
Identification of test methods used.
Refer to 820.30(f)
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
© 2025 All rights reserved
, 3 | Page
D. Fraudulent Ans: A. Adulteration
PMA products introduced into commercial distribution
without an approval PMA are considered to be
adulterated. FD&C Act 501(f).
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. Ans: C. A custom
device being studied for safety and effectiveness.
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 filed
(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.
© 2025 All rights reserved
, 4 | Page
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. Ans: A.
Preparing criteria for the MDR report.
MDR reporting is a post PMA approval requirement.
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. Ans:
D. A discussion of benefit and risk considerations.
See 21 CFR 814.20(b)(3)(vi).
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.
© 2025 All rights reserved
