RAC Drugs Exam Prep Comprehensive
Questions & answers graded A+
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
Answer: 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)
Answer: 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
Answer: C
4. A company's competitor is marketing a Class II suture which dissolves dur- ing 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
5. Which of the following is exempt from GMP/QSR regulations?
,A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Answer: 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
Answer: 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.
Answer: 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
Answer: 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.
C. You have changed the package of the device.
D. None of the above.
Answer: 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 investi- gation EXCEPT
A. The dates and results of the investigation
B. The nature and details of the complaint
Questions & answers graded A+
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
Answer: 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)
Answer: 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
Answer: C
4. A company's competitor is marketing a Class II suture which dissolves dur- ing 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
5. Which of the following is exempt from GMP/QSR regulations?
,A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Answer: 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
Answer: 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.
Answer: 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
Answer: 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.
C. You have changed the package of the device.
D. None of the above.
Answer: 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 investi- gation EXCEPT
A. The dates and results of the investigation
B. The nature and details of the complaint
