DEVICE RAC
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency
to determine that quality system activities comply with quality system procedures that these
procedures are implemented effectively and that procedures are suitable to achieve quality
system objectives.
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. Device history record
This contains the dates of manufacture, the quantity manufactured, the quantity released for
distribution, control numbers used and the acceptance records which demonstrate the device is
manufactured in accordance with the DMR. See 21 CFR 820.184.
,Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
A. Investigator shall report withdrawal of approval by the IRB to sponsor within 5 working days.
B. Investigator shall report device use without informed consent to sponsor and IRB within 10
working days after use occurs.
C. The sponsor shall notify FDA within 30 working days of the completion or termination of an
investigation for a sig 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. Investigator shall report device use without informed consent to sponsor and IRB
within 10 working days after use occurs.
The investigator shall report device use without obtaining informed consent to the sponsor and
the reviewing IRB within 5 working days after the use occurs. See 21 CFR 812.150(a)(5).
When a manufacturer is performing design validation activities, 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. Translation
of device design into production specifications
Translation of device design into production specifications is covered under 820.30(h) Design
transfer.
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 - CORRECT ANSWER-C. A custom device being studied for safety and
effectiveness in support of commercial marketing
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 filed; see 21 CFR 812.2(c)(7).
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. Report incidents in
which a device may have caused or contributed to a death or serious injury
Initial importers are subject to Medical Device Reporting (MDR) under 21 CFR 803.40.
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 - CORRECT ANSWER-C. Ensure that the study
director for the sponsor discusses the issue with the investigator
Per 812.150(a)(5) and (b)(8)
The regulatory affairs professional should perform all of the following prior to submitting a PMA
to FDA EXCEPT:
A. Prepare criteria for the MDR report
B. Prepare a brief statement of reasons for noncompliance with regulation
C. Identify all omissions in PMA content
D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation -
CORRECT ANSWER-A. Prepare criteria for the MDR report
MDR reporting is a post PMA approval requirement.
All Class I devices are subject to following EXCEPT:
A. Device Master File (DMF)
B. Design History File (DHF)
C. Device History Record (DHR)
D. Medical Device Reporting (MDR) - CORRECT ANSWER-B. Design History File (DHF)
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient frequency
to determine that quality system activities comply with quality system procedures that these
procedures are implemented effectively and that procedures are suitable to achieve quality
system objectives.
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. Device history record
This contains the dates of manufacture, the quantity manufactured, the quantity released for
distribution, control numbers used and the acceptance records which demonstrate the device is
manufactured in accordance with the DMR. See 21 CFR 820.184.
,Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
A. Investigator shall report withdrawal of approval by the IRB to sponsor within 5 working days.
B. Investigator shall report device use without informed consent to sponsor and IRB within 10
working days after use occurs.
C. The sponsor shall notify FDA within 30 working days of the completion or termination of an
investigation for a sig 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. Investigator shall report device use without informed consent to sponsor and IRB
within 10 working days after use occurs.
The investigator shall report device use without obtaining informed consent to the sponsor and
the reviewing IRB within 5 working days after the use occurs. See 21 CFR 812.150(a)(5).
When a manufacturer is performing design validation activities, 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. Translation
of device design into production specifications
Translation of device design into production specifications is covered under 820.30(h) Design
transfer.
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 - CORRECT ANSWER-C. A custom device being studied for safety and
effectiveness in support of commercial marketing
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 filed; see 21 CFR 812.2(c)(7).
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. Report incidents in
which a device may have caused or contributed to a death or serious injury
Initial importers are subject to Medical Device Reporting (MDR) under 21 CFR 803.40.
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 - CORRECT ANSWER-C. Ensure that the study
director for the sponsor discusses the issue with the investigator
Per 812.150(a)(5) and (b)(8)
The regulatory affairs professional should perform all of the following prior to submitting a PMA
to FDA EXCEPT:
A. Prepare criteria for the MDR report
B. Prepare a brief statement of reasons for noncompliance with regulation
C. Identify all omissions in PMA content
D. Review, organize and check adequacy of data pertaining to safety and efficacy evaluation -
CORRECT ANSWER-A. Prepare criteria for the MDR report
MDR reporting is a post PMA approval requirement.
All Class I devices are subject to following EXCEPT:
A. Device Master File (DMF)
B. Design History File (DHF)
C. Device History Record (DHR)
D. Medical Device Reporting (MDR) - CORRECT ANSWER-B. Design History File (DHF)
