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Device RAC Exam Questions from Quizlet
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Device RAC Exam Questions from QuizletWhich 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 - -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) - -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 - -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 - -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 - -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 - -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. - -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 - -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
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