DEVICE RAC EXAM QUESTIONS (2025) ACTUAL EXAM (TESTING
DEVICE RAC EXAM QUESTIONS
REAL EXAM QUESTIONS) AND VERIFIED ANSWERS (MULTIPLE
Study online at https://quizlet.com/_pm8dl
CHOICES) |
1. Which division would have primary jurisdiction over C
a vascular graft with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
2. A company wants to modify its legally marketed device A
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 de-
vice 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. Under the statutory violations, failure to meet 510(k) C
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
4. A company's competitor is marketing a Class II su- A
ture 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
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_pm8dl
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
5. Which of the following is exempt from GMP/QSR regu- D
lations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
6. A physician reports to a manufacturer that a patient C
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
7. If a device failure is occurring with greater than ex- A
pected frequency and investigation of the problem
implicates improper use by the end user, which of the
following typically occurs?
A. The labeling is revised.
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_pm8dl
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued.
8. A handling and storage system for medical devices C
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. You have modified your 510(k) cleared device with a D
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.
10. According to the QSR, when an investigation of a com- C
plaint is conducted all of the following are require-
ments 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
DEVICE RAC EXAM QUESTIONS
REAL EXAM QUESTIONS) AND VERIFIED ANSWERS (MULTIPLE
Study online at https://quizlet.com/_pm8dl
CHOICES) |
1. Which division would have primary jurisdiction over C
a vascular graft with an antibiotic based on primary
mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
2. A company wants to modify its legally marketed device A
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 de-
vice 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. Under the statutory violations, failure to meet 510(k) C
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
4. A company's competitor is marketing a Class II su- A
ture 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
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_pm8dl
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
5. Which of the following is exempt from GMP/QSR regu- D
lations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
6. A physician reports to a manufacturer that a patient C
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
7. If a device failure is occurring with greater than ex- A
pected frequency and investigation of the problem
implicates improper use by the end user, which of the
following typically occurs?
A. The labeling is revised.
, DEVICE RAC EXAM QUESTIONS
Study online at https://quizlet.com/_pm8dl
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued.
8. A handling and storage system for medical devices C
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. You have modified your 510(k) cleared device with a D
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.
10. According to the QSR, when an investigation of a com- C
plaint is conducted all of the following are require-
ments 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
