RAC Sample Test Questions and Answers | Latest Version | 2024/2025 | Already Passed
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RAC Sample Test Questions and
Answers | Latest Version | 2024/2025 |
Already Passed
What is the main focus of risk management in medical device development?
A) To identify, assess, and mitigate potential hazards associated with the device
B) To enhance product marketing strategies
C) To i...
RAC Sample Test Questions and
Answers | Latest Version | 2024/2025 |
Already Passed
What is the main focus of risk management in medical device development?
✔✔A) To identify, assess, and mitigate potential hazards associated with the device
B) To enhance product marketing strategies
C) To increase production speed
D) To evaluate sales performance
In the context of medical devices, what does the term "predicate device" refer to?
A) A device that is no longer in use
B) A device that has been withdrawn from the market
✔✔C) A legally marketed device to which a new device is compared for substantial equivalence
D) A device that is undergoing clinical trials
Which of the following is a key component of the FDA's Quality System Regulation (QSR)?
A) Enhanced customer service
B) Reduced production costs
1
,✔✔C) Establishing a framework for the manufacturing process to ensure consistent quality
D) Increasing the number of marketing strategies
What is one of the primary objectives of human factors engineering in device design?
A) To ensure aesthetic appeal
✔✔B) To enhance usability and minimize user error
C) To maximize production efficiency
D) To reduce regulatory compliance
What does the term "biocompatibility" refer to in medical devices?
A) The device's marketing potential
B) The device's ability to function in various environments
✔✔C) The device's ability to perform without causing adverse reactions in the body
D) The device's durability over time
When is a medical device considered "adulterated" under the Federal Food, Drug, and Cosmetic
Act?
✔✔A) If it fails to meet quality standards or is manufactured under unsanitary conditions
2
,B) If it is overproduced
C) If it is not properly marketed
D) If it has not been sold for a certain period
What is a key requirement for submitting a De Novo request to the FDA?
✔✔A) Providing evidence that the device is low to moderate risk and not substantially
equivalent to any existing device
B) Proving that the device has already been marketed
C) Demonstrating that the device can be manufactured at a lower cost
D) Showing that the device has been successfully used in Europe
Which of the following activities is critical during the design validation phase of a medical
device?
✔✔A) Conducting clinical evaluations to verify that the device meets user needs and intended
uses
B) Finalizing marketing strategies
C) Reducing manufacturing time
D) Developing financial projections
3
, What does the term "labeling" encompass for a medical device?
A) Only the packaging design
B) Marketing materials and advertisements
✔✔C) Instructions for use, safety warnings, and promotional claims about the device
D) Only the product description
What is the purpose of the FDA’s Investigational Device Exemption (IDE)?
A) To speed up the approval process for all medical devices
✔✔B) To allow a device to be used in clinical trials without pre-market approval
C) To ensure all devices undergo public scrutiny
D) To eliminate the need for post-market surveillance
Which of the following is considered part of the Device Master Record?
A. Employee training record
B. Labeling specifications
C. Design reviews
D. Calibration records ✔✔B. Labeling specifications
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