DEVICE RAC CORRECT FINAL EXAMS QUESTIONS
AND ANSWERS SURE A+
✔✔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. - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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) - ✔✔B. Design History File (DHF)
Most Class I devices are not subject to design controls under 21 CFR 820.30 and
therefore Design History Files are not required.
✔✔Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations - ✔✔D. A discussion of benefit and
risk considerations
See 21 CFR 814.20(b)(3)(vi).
✔✔MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of:
A. Class I and II devices
B. Class I devices only
C. Class II devices only
D. Class II and III device - ✔✔D. Class II and III device
Class I devices are the least hazardous and are not the primary focus of FDA
inspections. Third party inspections allow FDA to focus on higher-risk inspections.
✔✔MDUFMA authorized 3rd party establishment inspections under carefully prescribed
conditions. All the following are true EXCEPT:
A. The establishment must market at least one device in the US and must market a
device "in one or more foreign countries."
B. Manufacturers of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
AND ANSWERS SURE A+
✔✔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. - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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 - ✔✔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) - ✔✔B. Design History File (DHF)
Most Class I devices are not subject to design controls under 21 CFR 820.30 and
therefore Design History Files are not required.
✔✔Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations - ✔✔D. A discussion of benefit and
risk considerations
See 21 CFR 814.20(b)(3)(vi).
✔✔MDUFMA authorizes FDA-accredited persons to inspect qualified manufacturers of:
A. Class I and II devices
B. Class I devices only
C. Class II devices only
D. Class II and III device - ✔✔D. Class II and III device
Class I devices are the least hazardous and are not the primary focus of FDA
inspections. Third party inspections allow FDA to focus on higher-risk inspections.
✔✔MDUFMA authorized 3rd party establishment inspections under carefully prescribed
conditions. All the following are true EXCEPT:
A. The establishment must market at least one device in the US and must market a
device "in one or more foreign countries."
B. Manufacturers of class III devices are not eligible for 3rd party inspections.
C. In order to be eligible, an establishment's most recent inspection must be NAI or VAI.
