RAC 2016 US RAC Practice Exam 2024 |
100 Questions with 100% Correct
Answers | Verified | Latest Update 2024|
Graded 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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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. - ✔✔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.
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