DEVICE RAC EXAM QUESTIONS with Verified Answers
1. C
2. A
3. C
4. A
Which division would have primary jurisdiction over a vas-
cular graft with an antibiotic based on primary mode of
action?
A. CDER
B. CBER
C. CDRH
D. OCP
A company wants to modify its legally marketed device
such that ...
1. C Which division would have primary jurisdiction over a vas-
cular graft with an antibiotic based on primary mode of
action?
A. CDER
B. CBER
C. CDRH
D. OCP
2. A 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)
3. C Under the statutory violations, failure to meet 510(k) re-
quirements 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
4. A A company's competitor is marketing a Class II suture
which dissolves during the third week of use. The com-
pany's current product has to be removed by a physi-
cian. 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
, DEVICE RAC EXAM QUESTIONS with Verified Answers
C. After reporting clinical studies in an annual report
D. After submission of labeling change
5. D Which of the following is exempt from GMP/QSR regula-
tions?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
6. C A physician reports to a manufacturer that a patient was
hospitalized with acute sepsis after treatment with an ap-
proved 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
7. A If a device failure is occurring with greater than expected
frequency and investigation of the problem implicates im-
proper 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.
8. C 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 receipt and transfer of product
D. Environmentally controlled areas for products with shelf
life
9. D You have modified your 510(k) cleared device with a spe-
cial 510(k). In which of the following cases would you need
, DEVICE RAC EXAM QUESTIONS with Verified Answers
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 de-
vice.
C. You have changed the package of the device.
D. None of the above.
10. C According to the QSR, when an investigation of a com-
plaint is conducted all of the following are requirements for
inclusion in the record of the investigation 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
11. B The QSR calls for the manufacturer of finished devices to
carry out all of the following EXCEPT:
A. Conduct quality audits by individuals who do not have
direct responsibility for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and
re-audits
D. Have findings reviewed by management responsible for
the matters audited
12. B Which of the following subsystems is NOT required by
FDA in order to implement and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
D. Facility and equipment controls
13. A 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
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