DEVICE RAC LATEST EXAM ACTUAL 2026/2027 QUESTIONS
AND SOLUTIONS RATED A+
✔✔Per the QSR, when an investigation of a complaint is conducted, all of the following
are requirements for inclusion in investigation record 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. Changes in procedures correcting quality
problems
The requirement is for corrective and preventative action and only needed if corrective
action was taken per investigation. See Sec. 820.198. Complaint files.
✔✔The QSR calls for finished device mfgers to carry out all of the following EXCEPT:
A. Quality audits conducted by individuals who don't have direct responsibility for
operation being audited
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited - ✔✔B.
Annual audits of operations
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 - ✔✔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. - ✔✔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?
AND SOLUTIONS RATED A+
✔✔Per the QSR, when an investigation of a complaint is conducted, all of the following
are requirements for inclusion in investigation record 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. Changes in procedures correcting quality
problems
The requirement is for corrective and preventative action and only needed if corrective
action was taken per investigation. See Sec. 820.198. Complaint files.
✔✔The QSR calls for finished device mfgers to carry out all of the following EXCEPT:
A. Quality audits conducted by individuals who don't have direct responsibility for
operation being audited
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters audited - ✔✔B.
Annual audits of operations
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 - ✔✔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. - ✔✔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?
