Question
Answer
Explanation
What is the primary responsibility of a Regulatory Affairs professional in
the device industry?
A. To conduct clinical trials
B. To ensure compliance with regulatory requirements
C. To oversee the manufacturing process
D. To develop new devices
Which of the following does not typically require regulatory approval
before market introduction?
A. Class I devices
B. Class II devices
C. Class III devices
D. Investigational devices
What is required for the approval of a new diagnostic device in the U.S.?
A. FDA approval is not necessary for diagnostic devices
B. Only clinical data is required for approval
C. FDA clearance through the 510(k) process or approval through PMA
D. A premarket notification to a third-party organization
What is the role of the ISO 13485 standard in th e medical device industry?
A. To define the clinical trial protocols for medical devices
B. To establish requirements for quality management systems
C. To provide guidelines for medical device marketing
D. To monitor post-market performance of medical devices
Which of the following is a key requirement for maintaining FDA device
approval?
A. Annual clinical trials
B. Post-market surveillance to monitor safety and performance
C. Regular updates to labeling
D. A new 510(k) submission every year
What does a Clinical Evaluation Report (CER) typically include?
A. Details of the manufacturing process and quality controls
B. A review of clinical studies and evidence regarding the devic e’s safety
and efficacy
C. An analysis of the device’s market competition
D. A financial forecast for the device’s lifecycle
