DEVICE RAC CORE CORRECT QUESTIONS AND
ANSWERS SURE A+
✔✔According to the QSR, when an investigation of a complaint is conducted all of the
following are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - ✔✔C
✔✔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
, ✔✔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
✔✔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
✔✔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 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
ANSWERS SURE A+
✔✔According to the QSR, when an investigation of a complaint is conducted all of the
following are requirements for inclusion in the record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant - ✔✔C
✔✔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
, ✔✔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
✔✔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
✔✔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 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
