DEVICE RAC Practice Exam || Most Recent Exam Actual
Complete Real Exam Questions And Correct
Answers (Verified Answers) Already Graded A+ |
Guaranteed Success!! Newest Exam | Just
Released 2026-2027
The QSR calls for the manufacturer of finished devices to carry out all of the
following EXCEPT:
A. Conduct quality audits by individuals who do not have direct
responsibility for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited
B
Which of the following subsystems is NOT required by FDA in order to
implement and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls
B
,According to the Quality System Regulations, re-testing and re-evaluation of
nonconforming devices after rework activities must be documented in the:
A. Device history record
B. Device master record
C. Quality manual
D. Design history file
A
Under 21 CFR 812, the IDE regulation, which of the following statements is
FALSE?
A. An investigator shall report to the sponsor within 5 working days a
withdrawal of approval by the IRB.
B. The investigator shall report device use without obtaining informed
consent to the sponsor and the reviewing IRB within 10 working days after
the use occurs.
C. The sponsor shall notify FDA within 30 working days of the
completion or termination of an investigation for a significant risk
device.
D. An investigator shall submit to the sponsor and IRB a report of any
unanticipated adverse device effect within 10 working days after the
investigator first learns of the effect.
B
,Which of the following manufacturers must register their manufacturing facility
with FDA?
A. Component manufacturers who sell only to the device manufacturer
using their components
B. Domestic (US) contract manufacturers who follow another person's
specifications and do not commercially distribute the devices to the market
C. Domestic manufacturer of device being investigated under an IDE
D. Foreign manufacturers shipping devices into the US for sale in the US.
D
When design validation activities are being performed by a manufacturer, which
element is NOT included as a requirement under device design validation
section of the QSR?
A. Conformance to defined user needs and intended uses
B. Testing of production units under actual or simulated use conditions
C. Software validation
D. Translation of device design into production specifications
D
A manufacturer of which 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 in support of
commercial marketing
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 intended solely for veterinary use
C
, Which one of the following statements is NOT true with respect to both INDs
and IDEs for significant-risk products?
A. The investigational product must be manufactured in full compliance with
cGMP.
B. Clinical studies must be reviewed and approved by an Institutional Review
Board.
C. The IND or IDE goes into effect 30 days after FDA receives the
application, unless FDA notifies the sponsor otherwise.
D. The application must include an environmental impact statement that
contains a claim for categorical exclusion or an environmental assessment.
A
The initial importer of a medical device MUST:
A. Report incidents in which a device may have caused or contributed to a
death or serious injury
B. Maintain quality assurance files
C. Share responsibility for submittals with other distributors
D. Report device malfunctions in an annual report
A
During a monitoring visit, the sponsor discovers that an investigator had used a
device in a clinical investigation without obtaining informed consent from the
subject. Which of the following should the regulatory affairs professional
do?
A. Predate the informed consent with a memo to the site file
B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director for the sponsor discusses the issue with the
investigator
D. Report the protocol deviation to the IRB
C
Complete Real Exam Questions And Correct
Answers (Verified Answers) Already Graded A+ |
Guaranteed Success!! Newest Exam | Just
Released 2026-2027
The QSR calls for the manufacturer of finished devices to carry out all of the
following EXCEPT:
A. Conduct quality audits by individuals who do not have direct
responsibility for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited
B
Which of the following subsystems is NOT required by FDA in order to
implement and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls
B
,According to the Quality System Regulations, re-testing and re-evaluation of
nonconforming devices after rework activities must be documented in the:
A. Device history record
B. Device master record
C. Quality manual
D. Design history file
A
Under 21 CFR 812, the IDE regulation, which of the following statements is
FALSE?
A. An investigator shall report to the sponsor within 5 working days a
withdrawal of approval by the IRB.
B. The investigator shall report device use without obtaining informed
consent to the sponsor and the reviewing IRB within 10 working days after
the use occurs.
C. The sponsor shall notify FDA within 30 working days of the
completion or termination of an investigation for a significant risk
device.
D. An investigator shall submit to the sponsor and IRB a report of any
unanticipated adverse device effect within 10 working days after the
investigator first learns of the effect.
B
,Which of the following manufacturers must register their manufacturing facility
with FDA?
A. Component manufacturers who sell only to the device manufacturer
using their components
B. Domestic (US) contract manufacturers who follow another person's
specifications and do not commercially distribute the devices to the market
C. Domestic manufacturer of device being investigated under an IDE
D. Foreign manufacturers shipping devices into the US for sale in the US.
D
When design validation activities are being performed by a manufacturer, which
element is NOT included as a requirement under device design validation
section of the QSR?
A. Conformance to defined user needs and intended uses
B. Testing of production units under actual or simulated use conditions
C. Software validation
D. Translation of device design into production specifications
D
A manufacturer of which 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 in support of
commercial marketing
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 intended solely for veterinary use
C
, Which one of the following statements is NOT true with respect to both INDs
and IDEs for significant-risk products?
A. The investigational product must be manufactured in full compliance with
cGMP.
B. Clinical studies must be reviewed and approved by an Institutional Review
Board.
C. The IND or IDE goes into effect 30 days after FDA receives the
application, unless FDA notifies the sponsor otherwise.
D. The application must include an environmental impact statement that
contains a claim for categorical exclusion or an environmental assessment.
A
The initial importer of a medical device MUST:
A. Report incidents in which a device may have caused or contributed to a
death or serious injury
B. Maintain quality assurance files
C. Share responsibility for submittals with other distributors
D. Report device malfunctions in an annual report
A
During a monitoring visit, the sponsor discovers that an investigator had used a
device in a clinical investigation without obtaining informed consent from the
subject. Which of the following should the regulatory affairs professional
do?
A. Predate the informed consent with a memo to the site file
B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director for the sponsor discusses the issue with the
investigator
D. Report the protocol deviation to the IRB
C
