1
RAC Practice Exam 2025|Actual Exam Test(MULTIPLE
CHOICES) and (RATIONALES) questions and verified
answers |GET IT 100% ACCURATE!!
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. - (answers)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.
D. Use of a device without informed consent. - (answers)C. An unanticipated
adverse device effect.
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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. - (answers)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 - (answers)A. Adulteration
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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. - (answers)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.
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D. Reviewing, organizing and checking adequacy of data pertaining to safety and
efficacy evaluation. - (answers)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. - (answers)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. - (answers)B. In one rodent and one non-rodent
species.
RAC Practice Exam 2025|Actual Exam Test(MULTIPLE
CHOICES) and (RATIONALES) questions and verified
answers |GET IT 100% ACCURATE!!
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. - (answers)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.
D. Use of a device without informed consent. - (answers)C. An unanticipated
adverse device effect.
, 2
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. - (answers)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 - (answers)A. Adulteration
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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. - (answers)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.
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D. Reviewing, organizing and checking adequacy of data pertaining to safety and
efficacy evaluation. - (answers)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. - (answers)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. - (answers)B. In one rodent and one non-rodent
species.
