RAC 2016 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass
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RAC 2016 US RAC
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RAC 2016 US RAC
RAC 2016 US RAC Practice Exam
Questions and Answers | Latest Update |
2024/2025 | 100% Pass
What is the primary focus of the FDA's Good Manufacturing Practices (GMP)?
A) To reduce costs in manufacturing
B) To ensure quality and safety in the production of medical devices
C) To speed up ...
RAC 2016 US RAC Practice Exam
Questions and Answers | Latest Update |
2024/2025 | 100% Pass
What is the primary focus of the FDA's Good Manufacturing Practices (GMP)?
A) To reduce costs in manufacturing
✔✔B) To ensure quality and safety in the production of medical devices
C) To speed up the approval process
D) To enhance marketing strategies
What is the main purpose of a Risk Management File?
A) To list all marketed devices
✔✔B) To document identified risks and mitigation strategies for a device
C) To outline production schedules
D) To analyze sales data
Which of the following is an essential element of a Design Control Plan?
A) Advertising strategy
✔✔B) Verification and validation activities
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,C) Financial projections
D) Market analysis
What type of clinical trial is typically required for Class III devices?
✔✔A) Randomized controlled trial
B) Case study
C) Observational study
D) Survey research
What does the acronym IDE stand for in medical device regulation?
A) Informed Device Evaluation
✔✔B) Investigational Device Exemption
C) Integrated Device Examination
D) Internal Device Evaluation
Which of the following statements is true about the FDA's premarket approval (PMA) process?
A) It is used for all medical devices.
B) It requires only minimal clinical data.
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,✔✔C) It is necessary for high-risk devices to demonstrate safety and effectiveness.
D) It is a faster process than 510(k) clearance.
What does post-market surveillance involve?
A) Reducing production costs after a product launch
✔✔B) Monitoring the safety and effectiveness of a device once it is on the market
C) Preparing marketing materials
D) Conducting pre-market studies
Which document serves as the main evidence of a device's compliance with regulations?
✔✔A) Technical File
B) Marketing Authorization
C) Risk Assessment Report
D) User Manual
What is the role of the Regulatory Affairs Specialist in the medical device industry?
✔✔A) To ensure compliance with regulatory requirements
B) To develop marketing strategies
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, C) To manage the supply chain
D) To conduct clinical trials
What must a manufacturer do if they receive reports of a serious adverse event related to their
device?
A) Ignore the reports if the device is performing well
✔✔B) Report the event to the FDA within a specified timeframe
C) Conduct a market analysis
D) Modify their advertising strategy
Which of the following is NOT a classification of medical devices according to the FDA?
A) Class I
B) Class II
✔✔C) Class IV
D) Class III
What is the function of a Quality Management System (QMS) in medical device manufacturing?
A) To increase sales
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