DEOMI: Racism questions well answered rated 2024

Quiz:Which division would have primary jurisdiction over a vascular graft with
an antibiotic based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - √Answer :C
Quiz: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) - √Answer :A
Quiz:Under the statutory violations, failure to meet 510(k) requirementsfor 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 - √Answer :C
Quiz: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 - √Answer :A
Quiz:Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - √Answer :D
Quiz: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 - √Answer :C
Quiz:If a device failure is occurring with greater than expected frequency and
investigation of the problem implicatesimproper use by the end user, which of
the following typically occurs?
A. The labeling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued. - √Answer :A
Quiz:A handling and storage system for medical devices must always include:
A. Proceduresfor rotation ofstock
B. Separate rooms or cagesfor release and quarantine products
C. Proceduresfor receipt and transfer of product
D. Environmentally controlled areasfor products with shelf life - √Answer :C
Quiz: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. - √Answer :D