RAC Practice Exam 2025|Actual Exam Test(MULTIPLE CHOICES) and
2009 RAC Practice Exam
(RATIONALES) questions and verified answers |GET IT 100%
Study online at https://quizlet.com/_1es8x3
ACCURATE!!
1. A physician reports to a manufacturer C. 30 calendar days.
that a patient was hospitalized with
acute sepsis after treatment with an Serious injury must be reported within 30 days. 21
approved device. This side effect is CFR 803.50(a).
not listed in the package insert. This
event must be reported by the manu-
facturer to FDA no later than:
A. 5 calendar days.
B. 15 calendar days.
C. 30 calendar days.
D. The next quarterly or annual re-
port.
2. Under the IDE regulation, all of the C. An unanticipated adverse device effect.
following must be reported to the
sponsor within five working days EX- The investigator notifies the sponsor and IRB with-
CEPT: in 10 days of notification of any unanticipated ad-
verse effect. 21 CFR 812.150.
A. A deviation from the investigational
plan.
B. Withdrawal of IRB approval.
C. An unanticipated adverse device ef-
fect.
D. Use of a device without informed
consent.
3. When design verification testing is C. Identification of test methods used.
being performed by a manufactur-
er, which element is NOT included Refer to 820.30(f)
as a potential requirement under de-
vice design verification section of the
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
QSR?
A. Identification of the design.
B. Software validation.
C. Identification of test methods
used.
D. Name of individuals performing
the testing.
4. Under the statutory violations, lack of A. Adulteration
an approved PMA for a PMA device
that is not exempt and is in commer- PMA products introduced into commercial distrib-
cial distribution is considered to be: ution without an approval PMA are considered to
be adulterated. FD&C Act 501(f).
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
5. A manufacturer of the following must C. A custom device being studied for safety and
file an IDE before conducting a hu- effectiveness.
man clinical study?
While a custom device may be studied in humans
A. A device in commercial distribu- without an IDE, if its safety and efficacy are being
tion before 28 May 1976 when used studied in support of commercial marketing, an
or investigated in accordance with its IDE must be filed (21 CFR 812.2(c)(7)
indications in labeling in effect at that
time.
B. A device intended solely for veteri-
nary use.
C. A custom device being studied for
safety and effectiveness.
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
D. A device in commercial distribu-
tion 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.
6. The regulatory affairs professional A. Preparing criteria for the MDR report.
performs all of the following prior to
submitting a PMA to FDA EXCEPT: MDR reporting is a post PMA approval require-
ment.
A. Preparing criteria for the MDR re-
port.
B. Preparing a brief statement of rea-
sons for noncompliance with regula-
tion.
C. Identifying all omissions in PMA
content.
D. Reviewing, organizing and check-
ing adequacy of data pertaining to
safety and efficacy evaluation.
7. Which of the following sections is re- D. A discussion of benefit and risk considerations.
quired in a PMA?
See 21 CFR 814.20(b)(3)(vi).
A. Patent certification information.
B. A copy of quality manual.
C. An economic cost/benefit assess-
ment.
D. A discussion of benefit and risk
considerations.
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
8. Subacute toxicity testing should be B. In one rodent and one non-rodent species.
performed:
See ICH guideline M3 Maintenance of The ICH
A. In two rodent species. Guideline on Non-Clinical Safety Studies for The
B. In one rodent and one non-rodent Conduct of Human Clinical Trials for Pharmaceuti-
species. cals.
C. For a minimum of two weeks.
D. For a minimum of six months.
9. What FDA clearances are required to C. No clearance required.
export a drug approved by FDA?
There are no FDA export requirements for ap-
A. Certificate of Free Sale. proved products.
B. Customs Tax Stamps.
C. No clearance required.
D. FDA receipt for sample Form-484.
10. Fully quality-assured individual toxi- B. 120 days.
cology reports are not required for
submission of an initial IND applica- See FDA "Guidance for Industry Q & A: Content and
tion. However, finalized and fully qual- Format of INDs for Phase 1 Studies of Drugs, In-
ity assured reports should be avail- cluding Well-Characterized, Therapeutic, Biotech-
able to FDA upon request within what nology-Derived Products." October 2000.
period of the start of the human
study?
A. 90 days.
B. 120 days.
C. One year.
D. The final report is only required in
the submission for the NDA.
2009 RAC Practice Exam
(RATIONALES) questions and verified answers |GET IT 100%
Study online at https://quizlet.com/_1es8x3
ACCURATE!!
1. A physician reports to a manufacturer C. 30 calendar days.
that a patient was hospitalized with
acute sepsis after treatment with an Serious injury must be reported within 30 days. 21
approved device. This side effect is CFR 803.50(a).
not listed in the package insert. This
event must be reported by the manu-
facturer to FDA no later than:
A. 5 calendar days.
B. 15 calendar days.
C. 30 calendar days.
D. The next quarterly or annual re-
port.
2. Under the IDE regulation, all of the C. An unanticipated adverse device effect.
following must be reported to the
sponsor within five working days EX- The investigator notifies the sponsor and IRB with-
CEPT: in 10 days of notification of any unanticipated ad-
verse effect. 21 CFR 812.150.
A. A deviation from the investigational
plan.
B. Withdrawal of IRB approval.
C. An unanticipated adverse device ef-
fect.
D. Use of a device without informed
consent.
3. When design verification testing is C. Identification of test methods used.
being performed by a manufactur-
er, which element is NOT included Refer to 820.30(f)
as a potential requirement under de-
vice design verification section of the
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
QSR?
A. Identification of the design.
B. Software validation.
C. Identification of test methods
used.
D. Name of individuals performing
the testing.
4. Under the statutory violations, lack of A. Adulteration
an approved PMA for a PMA device
that is not exempt and is in commer- PMA products introduced into commercial distrib-
cial distribution is considered to be: ution without an approval PMA are considered to
be adulterated. FD&C Act 501(f).
A. Adulteration
B. Improper use
C. Misbranded
D. Fraudulent
5. A manufacturer of the following must C. A custom device being studied for safety and
file an IDE before conducting a hu- effectiveness.
man clinical study?
While a custom device may be studied in humans
A. A device in commercial distribu- without an IDE, if its safety and efficacy are being
tion before 28 May 1976 when used studied in support of commercial marketing, an
or investigated in accordance with its IDE must be filed (21 CFR 812.2(c)(7)
indications in labeling in effect at that
time.
B. A device intended solely for veteri-
nary use.
C. A custom device being studied for
safety and effectiveness.
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
D. A device in commercial distribu-
tion 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.
6. The regulatory affairs professional A. Preparing criteria for the MDR report.
performs all of the following prior to
submitting a PMA to FDA EXCEPT: MDR reporting is a post PMA approval require-
ment.
A. Preparing criteria for the MDR re-
port.
B. Preparing a brief statement of rea-
sons for noncompliance with regula-
tion.
C. Identifying all omissions in PMA
content.
D. Reviewing, organizing and check-
ing adequacy of data pertaining to
safety and efficacy evaluation.
7. Which of the following sections is re- D. A discussion of benefit and risk considerations.
quired in a PMA?
See 21 CFR 814.20(b)(3)(vi).
A. Patent certification information.
B. A copy of quality manual.
C. An economic cost/benefit assess-
ment.
D. A discussion of benefit and risk
considerations.
, 2009 RAC Practice Exam
Study online at https://quizlet.com/_1es8x3
8. Subacute toxicity testing should be B. In one rodent and one non-rodent species.
performed:
See ICH guideline M3 Maintenance of The ICH
A. In two rodent species. Guideline on Non-Clinical Safety Studies for The
B. In one rodent and one non-rodent Conduct of Human Clinical Trials for Pharmaceuti-
species. cals.
C. For a minimum of two weeks.
D. For a minimum of six months.
9. What FDA clearances are required to C. No clearance required.
export a drug approved by FDA?
There are no FDA export requirements for ap-
A. Certificate of Free Sale. proved products.
B. Customs Tax Stamps.
C. No clearance required.
D. FDA receipt for sample Form-484.
10. Fully quality-assured individual toxi- B. 120 days.
cology reports are not required for
submission of an initial IND applica- See FDA "Guidance for Industry Q & A: Content and
tion. However, finalized and fully qual- Format of INDs for Phase 1 Studies of Drugs, In-
ity assured reports should be avail- cluding Well-Characterized, Therapeutic, Biotech-
able to FDA upon request within what nology-Derived Products." October 2000.
period of the start of the human
study?
A. 90 days.
B. 120 days.
C. One year.
D. The final report is only required in
the submission for the NDA.
