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Device RAC Exam Questions and Answers
Which division has 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. CDRH
In this combination of a device and a drug, the primary mode of action is
that of the vascular graft (device). The antibiotic is supportive in this
case.
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)
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Ans: A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed
device is being made that relies on compliance with design controls,
including design validation. The incentive provided for manufacturers to
choose this option is that ODE intends to process special 510(k)s within
30 days of receipt. See the CDRH guidance published in 1998 entitled
The New 510(k) Paradigm - Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications.
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. Misbranded
A marketed device that needs a 510(k) for commercialization but failed
to comply with the requirements is considered to be Misbranded. See the
FD&C Act, 502(o).
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
C. After reporting clinical studies in an annual report
D. After submission of labeling change
© 2025 All rights reserved
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Ans: A. This requires a new 510(k) since significant change in product
instructions might affect efficacy.
A new intended use requires a 510(k) clearance.
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. 30 calendar days
Serious injury must be reported within 30 days even if it is expected and
stated in the IFU
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 product receipt and transfer
D. Environmentally controlled areas for products with shelf life
Ans: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR
820.150(b).
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?
© 2025 All rights reserved
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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.
Ans: D. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be
submitted for each device or device class listed with the FDA. Devices
having variations in physical characteristics such as size, package,
shape, color or composition should be considered to be one device:
Provided, The variation does not change the function or intended use of
the device.
Per the QSR, when an investigation of a complaint is conducted,
all of the following are requirements for inclusion in investigation
record 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. Changes in procedures correcting quality problems
The requirement is for corrective and preventative action and only
needed if corrective action was taken per investigation. See Sec. 820.198.
Complaint files.
The QSR calls for finished device mfgers to carry out all of the
following EXCEPT:
A. Quality audits conducted by individuals who don't have direct
responsibility for operation being audited
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the
matters audited
© 2025 All rights reserved
Device RAC Exam Questions and Answers
Which division has 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. CDRH
In this combination of a device and a drug, the primary mode of action is
that of the vascular graft (device). The antibiotic is supportive in this
case.
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)
© 2025 All rights reserved
, 2 | Page
Ans: A. Special 510(k)
A Special 510(k) is allowed if a modification to the legally marketed
device is being made that relies on compliance with design controls,
including design validation. The incentive provided for manufacturers to
choose this option is that ODE intends to process special 510(k)s within
30 days of receipt. See the CDRH guidance published in 1998 entitled
The New 510(k) Paradigm - Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications.
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. Misbranded
A marketed device that needs a 510(k) for commercialization but failed
to comply with the requirements is considered to be Misbranded. See the
FD&C Act, 502(o).
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
C. After reporting clinical studies in an annual report
D. After submission of labeling change
© 2025 All rights reserved
, 3 | Page
Ans: A. This requires a new 510(k) since significant change in product
instructions might affect efficacy.
A new intended use requires a 510(k) clearance.
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. 30 calendar days
Serious injury must be reported within 30 days even if it is expected and
stated in the IFU
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 product receipt and transfer
D. Environmentally controlled areas for products with shelf life
Ans: C. Procedures for product receipt and transfer
Procedures for receipt and transfer of products are required; see 21 CFR
820.150(b).
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?
© 2025 All rights reserved
, 4 | 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.
Ans: D. None of the above.
According to 21 CFR 807.22(b), a separate form FDA-2892 shall be
submitted for each device or device class listed with the FDA. Devices
having variations in physical characteristics such as size, package,
shape, color or composition should be considered to be one device:
Provided, The variation does not change the function or intended use of
the device.
Per the QSR, when an investigation of a complaint is conducted,
all of the following are requirements for inclusion in investigation
record 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. Changes in procedures correcting quality problems
The requirement is for corrective and preventative action and only
needed if corrective action was taken per investigation. See Sec. 820.198.
Complaint files.
The QSR calls for finished device mfgers to carry out all of the
following EXCEPT:
A. Quality audits conducted by individuals who don't have direct
responsibility for operation being audited
B. Annual audits of operations
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the
matters audited
© 2025 All rights reserved
