Device RAC Exam [ACTUAL EXAM] LATEST VERSION
[QUESTIONS AND ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
Device RAC Exam [ACTUAL EXAM] LATEST VERSION
[QUESTIONS AND ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
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) - KEY TERM 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 - KEY TERM 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 - KEY TERM 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 - KEY TERM 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 - KEY TERM 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?
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. - KEY TERM 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 - KEY TERM 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 - KEY
TERM B. Annual audits of operations
Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient
frequency to determine that quality system activities comply with quality system
procedures that these procedures are implemented effectively and that procedures are
suitable to achieve quality system objectives.
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 - KEY TERM A. Device history record
This contains the dates of manufacture, the quantity manufactured, the quantity
released for distribution, control numbers used and the acceptance records which
demonstrate the device is manufactured in accordance with the DMR. See 21 CFR
820.184.
Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
[QUESTIONS AND ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
Device RAC Exam [ACTUAL EXAM] LATEST VERSION
[QUESTIONS AND ANSWERS] WITH PRACTICE EXAM
DETAILED AND VERIFIED FOR GUARANTEED PASS- LATEST
UPDATE 2025 GRADED A
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) - KEY TERM 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 - KEY TERM 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 - KEY TERM 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 - KEY TERM 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 - KEY TERM 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?
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. - KEY TERM 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 - KEY TERM 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 - KEY
TERM B. Annual audits of operations
Under CFR 820.3(t), an audit must be performed at defined intervals and at sufficient
frequency to determine that quality system activities comply with quality system
procedures that these procedures are implemented effectively and that procedures are
suitable to achieve quality system objectives.
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 - KEY TERM A. Device history record
This contains the dates of manufacture, the quantity manufactured, the quantity
released for distribution, control numbers used and the acceptance records which
demonstrate the device is manufactured in accordance with the DMR. See 21 CFR
820.184.
Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
