Device RAC Exam Questions from
Quizlet
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.
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
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
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
Quizlet
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.
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
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
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
