DEVICE RAC EXAM QUESTIONS WITH VERIFIED
Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - Correct Answer - C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the vascular
graft (device). The antibiotic is supportive in this case.
A company wants to modify its legally marketed device such that the modification does not
affect the intended use or alter the fundamental scientific technology of the device. If the design
outputs of the modified device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - Correct Answer - A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed device is being made that
relies on compliance with design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30
days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
Under the statutory violations, failure to meet 510(k) requirements for a device that is required to
have a 510(k) and is in commercial distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - Correct Answer - C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed to comply with the
requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A company's competitor is marketing a Class II suture which dissolves during the third week of
use. The company's current product has to be removed by a physician. However, a change in
,weaving configuration gives this product the same dissolving time as the competitor's. When can
the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might affect
efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change - Correct Answer - A. This requires a new 510(k) since
significant change in product instructions might affect efficacy.
Serious injury must be reported within 30 days even if it is expected and stated in the IFU
A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf life - Correct Answer - C.
Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR 820.150(b).
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. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device
or device class listed with the FDA. Devices having variations in physical characteristics such as
size, package, shape, color or composition should be considered to be one device: Provided, The
variation does not change the function or intended use of the device.
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 - Correct Answer - 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 - Correct Answer
- B. Annual audits of operations
A new intended use requires a 510(k) clearance.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after
treatment with an approved device. This side effect is not listed in the package insert. This event
must be reported by the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Correct Answer - C. 30 calendar days
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.
, 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
Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - Correct Answer - C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the vascular
graft (device). The antibiotic is supportive in this case.
A company wants to modify its legally marketed device such that the modification does not
affect the intended use or alter the fundamental scientific technology of the device. If the design
outputs of the modified device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - Correct Answer - A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed device is being made that
relies on compliance with design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30
days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
Under the statutory violations, failure to meet 510(k) requirements for a device that is required to
have a 510(k) and is in commercial distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - Correct Answer - C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed to comply with the
requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A company's competitor is marketing a Class II suture which dissolves during the third week of
use. The company's current product has to be removed by a physician. However, a change in
,weaving configuration gives this product the same dissolving time as the competitor's. When can
the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might affect
efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change - Correct Answer - A. This requires a new 510(k) since
significant change in product instructions might affect efficacy.
Serious injury must be reported within 30 days even if it is expected and stated in the IFU
A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with shelf life - Correct Answer - C.
Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR 820.150(b).
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. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for each device
or device class listed with the FDA. Devices having variations in physical characteristics such as
size, package, shape, color or composition should be considered to be one device: Provided, The
variation does not change the function or intended use of the device.
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 - Correct Answer - 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 - Correct Answer
- B. Annual audits of operations
A new intended use requires a 510(k) clearance.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after
treatment with an approved device. This side effect is not listed in the package insert. This event
must be reported by the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Correct Answer - C. 30 calendar days
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.
, 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
