DEVICE RAC EXAM QUESTIONS
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1. 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: C
2. A company wants to modify its legally marketed device such that the mod-
ification 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
3. 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
4. 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
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C. After reporting clinical studies in an annual report
D. After submission of labeling change: A
5. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers: D
6. 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
7. If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper 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.: A
8. 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: C
9. 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.
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C. You have changed the package of the device.
D. None of the above.: D
10. According to the QSR, when an investigation of a complaint 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: C
11. 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 audit-
ed: B
12. 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: B
13. 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
14. Which of the following manufacturers must register their manufacturing
facility with FDA?
A. Component manufacturers who sell only to the device manufacturer using
Study online at https://quizlet.com/_i2snug
1. 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: C
2. A company wants to modify its legally marketed device such that the mod-
ification 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
3. 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
4. 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
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_i2snug
C. After reporting clinical studies in an annual report
D. After submission of labeling change: A
5. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers: D
6. 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
7. If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper 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.: A
8. 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: C
9. 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.
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_i2snug
C. You have changed the package of the device.
D. None of the above.: D
10. According to the QSR, when an investigation of a complaint 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: C
11. 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 audit-
ed: B
12. 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: B
13. 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
14. Which of the following manufacturers must register their manufacturing
facility with FDA?
A. Component manufacturers who sell only to the device manufacturer using
