1 | Page
DEVICE RAC EXAM Questions and
Answers
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
Ans: C
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)
Ans: 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
Ans: C
A company's competitor is marketing a Class II suture which
dissolves during the third week of use. The company's current
© 2025 All rights reserved
, 2 | Page
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
Ans: A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Ans: 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
Ans: C
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.
© 2025 All rights reserved
, 3 | Page
D. A "Dear Doctor" letter is issued.
Ans: 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
Ans: 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?
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.
Ans: 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
Ans: C
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
© 2025 All rights reserved
, 4 | Page
D. Have findings reviewed by management responsible for the
matters audited
Ans: 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
Ans: B
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
Ans: A
Which of the following manufacturers must register their
manufacturing facility with FDA?
A. Component manufacturers who sell only to the device
manufacturer using their
components
B. Domestic (US) contract manufacturers who follow another
person's specifications and
do not commercially distribute the devices to the market
C. Domestic manufacturer of device being investigated under an
IDE
D. Foreign manufacturers shipping devices into the US for sale in
the US.
Ans: D
© 2025 All rights reserved
DEVICE RAC EXAM Questions and
Answers
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
Ans: C
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)
Ans: 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
Ans: C
A company's competitor is marketing a Class II suture which
dissolves during the third week of use. The company's current
© 2025 All rights reserved
, 2 | Page
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
Ans: A
Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers
Ans: 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
Ans: C
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.
© 2025 All rights reserved
, 3 | Page
D. A "Dear Doctor" letter is issued.
Ans: 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
Ans: 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?
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.
Ans: 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
Ans: C
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
© 2025 All rights reserved
, 4 | Page
D. Have findings reviewed by management responsible for the
matters audited
Ans: 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
Ans: B
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
Ans: A
Which of the following manufacturers must register their
manufacturing facility with FDA?
A. Component manufacturers who sell only to the device
manufacturer using their
components
B. Domestic (US) contract manufacturers who follow another
person's specifications and
do not commercially distribute the devices to the market
C. Domestic manufacturer of device being investigated under an
IDE
D. Foreign manufacturers shipping devices into the US for sale in
the US.
Ans: D
© 2025 All rights reserved
