PRACTICE RAC EXAM REVIEW 2026 FULL
QUESTIONS AND VERIFIED ANSWERS
GRADED 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.
D. Use of a device without informed consent. Answer: 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. Answer: 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
D. Fraudulent Answer: 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. Answer: 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.
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. 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. Answer: 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.
D. For a minimum of six months. Answer: B. In one rodent and one
non-rodent species.
See ICH guideline M3 Maintenance of The ICH Guideline on Non-
Clinical Safety Studies for The Conduct of Human Clinical Trials for
Pharmaceuticals.
⩥ What FDA clearances are required to export a drug approved by
FDA?
QUESTIONS AND VERIFIED ANSWERS
GRADED 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.
D. Use of a device without informed consent. Answer: 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. Answer: 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
D. Fraudulent Answer: 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. Answer: 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.
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. 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. Answer: 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.
D. For a minimum of six months. Answer: B. In one rodent and one
non-rodent species.
See ICH guideline M3 Maintenance of The ICH Guideline on Non-
Clinical Safety Studies for The Conduct of Human Clinical Trials for
Pharmaceuticals.
⩥ What FDA clearances are required to export a drug approved by
FDA?
