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RAC Devices Exam with correct answers
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RAC Devices Exam with correct answers
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RAC Devices Exam with correct answersWhich of the following is a primary regulatory body for medical devices in the United States?
A) European Medicines Agency (EMA)
B) Medicines and Healthcare products Regulatory Agency (MHRA)
C) Food and Drug Administration (FDA)
D) Therapeutic Goods Administration (TGA) - ** VERIFIED ANSWERS **✔✔C) Food and Drug
Administration
What is the purpose of a 510(k) submission?
A) To obtain premarket approval for a high-risk device
B) To demonstrate that a device is substantially equivalent to a legally marketed device
C) To apply for a CE mark for European market entry
D) To report adverse events related to a device - ** VERIFIED ANSWERS **✔✔B) To demonstrate
that a device is substantially equivalent to a legally marketed device
Which of the following is true about ISO 13485?
A) It is a standard for environmental management systems
B) It provides guidelines for clinical trial design
C) It specifies requirements for a quality management system specific to medical devices
D) It is a regulatory submission process for high-risk devices - ** VERIFIED ANSWERS **✔✔C) It
specifies requirements for a quality management system specific to medical devices
What is required for a device to obtain CE marking?
A) Approval from the FDA
B) A premarket notification (510(k))
C) Demonstration of conformity with EU regulatory requirements
,D) Submission of a clinical evaluation report to the FDA - ** VERIFIED ANSWERS **✔✔C)
Demonstration of conformity with EU regulatory requirements
Which risk management process involves identifying potential hazards associated with a medical
device?
A) Risk Control
B) Risk Analysis
C) Risk Assessment
D) Risk Mitigation - ** VERIFIED ANSWERS **✔✔B) Risk Analysis
Describe the difference between a Class I and a Class III medical device. Provide examples of each. -
** VERIFIED ANSWERS **✔✔Class I devices are considered low risk and typically require general
controls (e.g., bandages). Class III devices are high risk and require premarket approval (e.g.,
pacemakers).
What are the key components of a Device Master Record (DMR)? - ** VERIFIED ANSWERS
**✔✔Key components of a DMR include: production specifications, production process
specifications, quality assurance procedures, and packaging and labeling requirements
Explain the significance of post-market surveillance in regulatory affairs for medical devices. - **
VERIFIED ANSWERS **✔✔Post-marketing surveillance involves monitoring the device's
performance and safety after it is on the market, including tracking adverse events and
implementing corrective actions (as needed).
Outline the steps involved in preparing a premarket approval (PMA) application. - ** VERIFIED
ANSWERS **✔✔Steps involved in a PMA application include:
- pre-submission meetings with the FDA
- preparation of the PMA application (including clinical data)
-submission of the application
-FDA review
-potential approval with conditions
, What is the role of an Institutional Review Board (IRB) in clinical trials for medical devices? - **
VERIFIED ANSWERS **✔✔An IRB reviews and approves clinical trial protocols to ensure ethical
standards and participant safety are maintained.
A medical device company is preparing to launch a new infusion pump in the U.S. and European
markets. The company is seeking regulatory approval in both regions.
Identify the regulatory submissions required for the U.S. market and the European market. - **
VERIFIED ANSWERS **✔✔For the U.S. market: 510(k) submission or PMA depending on the risk
classification.
For the European market: CE marking submission with a Notified Body.
A medical device company is preparing to launch a new infusion pump in the U.S. and European
markets. The company is seeking regulatory approval in both regions.
Discuss the key considerations and documentation needed for each submission type. - ** VERIFIED
ANSWERS **✔✔For the U.S. market, 510(k) or PMA documentation includes:
-device description
-intended use
-substantial equivalence
-clinical data
-manufacturing information.
For the European market, CE marking documentation includes:
-technical file
-clinical evaluation
-risk management file
-conformity assessment.
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