2025 US RAC PRACTICE EXAM
QUESTIONS & 100% CORRECT
ANSWERS
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.
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. - correct answer ✔✔Explanation:
B. This item is required by 814.20(b)
The correct answer is A
,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.
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)).
The correct answer is C.
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. - 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))
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. - correct answer ✔✔Explanation:
D. See 21 CFR 814.20(b)(3)(vi)
D. A discussion of benefit and risk considerations
, 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. - correct answer ✔✔Explanation:
B. See ICH guideline M3 Maintenance of The ICH Guideline on Non-Clinical Safety Studies for
The
Conduct of Human Clinical Trials for Pharmaceuticals.
B. In one rodent and one non-rodent species.
What FDA clearances are required to export a drug approved by FDA?
A. Certificate of Free Sale.
B. Customs Tax Stamps.
C. No clearance required.
D. FDA receipt for sample Form-484. - correct answer ✔✔Explanation:
C. There are no FDA export requirements for approved products.
C. No clearance required.
Fully quality-assured individual toxicology reports are not required for submission of an initial
IND application. However, finalized and fully quality assured reports should be available to FDA
upon request within what period of the start of the human study?
A 90 days.
B. 120 days.
C. One year.
QUESTIONS & 100% CORRECT
ANSWERS
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.
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. - correct answer ✔✔Explanation:
B. This item is required by 814.20(b)
The correct answer is A
,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.
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)).
The correct answer is C.
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. - 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))
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. - correct answer ✔✔Explanation:
D. See 21 CFR 814.20(b)(3)(vi)
D. A discussion of benefit and risk considerations
, 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. - correct answer ✔✔Explanation:
B. See ICH guideline M3 Maintenance of The ICH Guideline on Non-Clinical Safety Studies for
The
Conduct of Human Clinical Trials for Pharmaceuticals.
B. In one rodent and one non-rodent species.
What FDA clearances are required to export a drug approved by FDA?
A. Certificate of Free Sale.
B. Customs Tax Stamps.
C. No clearance required.
D. FDA receipt for sample Form-484. - correct answer ✔✔Explanation:
C. There are no FDA export requirements for approved products.
C. No clearance required.
Fully quality-assured individual toxicology reports are not required for submission of an initial
IND application. However, finalized and fully quality assured reports should be available to FDA
upon request within what period of the start of the human study?
A 90 days.
B. 120 days.
C. One year.
