, RAC DEVICES EXAM |NEWEST PRACTICE EXAM
2024 |ACTUAL COMPLETE QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |PRE-ASSESSED A+
Which 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) - ANSWER-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 - ANSWER-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 - ANSWER-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 - ANSWER-C) Demonstration
of conformity with EU regulatory requirements
2024 |ACTUAL COMPLETE QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |PRE-ASSESSED A+
Which 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) - ANSWER-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 - ANSWER-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 - ANSWER-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 - ANSWER-C) Demonstration
of conformity with EU regulatory requirements
