1|Page
DEVICE RAC EXAM ||VERIFIED EXAM!!|| MOST
RECENT EXAM ACTUAL COMPLETE REAL EXAM
QUESTIONS AND CORRECT ANSWERS (VERIFIED
ANSWERS) ALREADY GRADED A+ | GUARANTEED
SUCCESS!! | NEWEST EXAM!!!
Which of the following is exempt from GMP/QSR
regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - Answer-D
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
,2|Page
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
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
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?
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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
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 - Answer-C
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
, 4|Page
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
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
A company's competitor is marketing a Class II suture
which dissolves during the third week of use. The
DEVICE RAC EXAM ||VERIFIED EXAM!!|| MOST
RECENT EXAM ACTUAL COMPLETE REAL EXAM
QUESTIONS AND CORRECT ANSWERS (VERIFIED
ANSWERS) ALREADY GRADED A+ | GUARANTEED
SUCCESS!! | NEWEST EXAM!!!
Which of the following is exempt from GMP/QSR
regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - Answer-D
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
,2|Page
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
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
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?
,3|Page
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
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 - Answer-C
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
, 4|Page
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
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
A company's competitor is marketing a Class II suture
which dissolves during the third week of use. The
