DEVICE RAC EXAM STUDY
GUIDE QUESTIONS AND
VERIFIED CORRECT
ANSWERS GRADED A+
[LATEST] 100% GUARANTEED
PASS
You have modified your 510(k) cleared device with a special 510(k). In which of the following
cases would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - CORRECT ANSWER-D
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 - CORRECT ANSWER-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 - CORRECT
ANSWER-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 - CORRECT ANSWER-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 - CORRECT ANSWER-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. - CORRECT ANSWER-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. - CORRECT ANSWER-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 - CORRECT ANSWER-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 - CORRECT ANSWER-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. - CORRECT ANSWER-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 - CORRECT ANSWER-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
GUIDE QUESTIONS AND
VERIFIED CORRECT
ANSWERS GRADED A+
[LATEST] 100% GUARANTEED
PASS
You have modified your 510(k) cleared device with a special 510(k). In which of the following
cases would you need to create a new listing for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above. - CORRECT ANSWER-D
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 - CORRECT ANSWER-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 - CORRECT
ANSWER-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 - CORRECT ANSWER-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 - CORRECT ANSWER-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. - CORRECT ANSWER-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. - CORRECT ANSWER-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 - CORRECT ANSWER-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 - CORRECT ANSWER-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. - CORRECT ANSWER-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 - CORRECT ANSWER-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
