US RAC Practice Exam Latest Questions and Answers| Verified Answers

US RAC Practice Exam Latest Questions and Answers| Verified Answers

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: - 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.

[Ans: - 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 .

[Ans: - Explanation:

B. Software validation is generally included in design validation, not verification (820.30 (g)).

The correct answer is C.

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. [Ans: - 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.

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: - 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))

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. [Ans: - Explanation:

B. This item is required by 814.20(b)

The correct answer is A

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: - 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. [Ans: - 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. [Ans: - Explanation:

C. There are no FDA export requirements for approved products.

C. No clearance required.