30 Questions
Which acronym stands for Food and Drug Administration?
FDA
What does IDE stand for?
Investigational Device Exemption
What is the purpose of a gold standard when testing a new device?
To establish a benchmark for comparison
What is the role of the FDA in medical device approval?
To regulate clinical trials
Which type of medical devices require FDA approval and are classified as significant risk?
Significant Risk (SR)
What type of devices are classified as non-significant risk and require only IRB approval?
Non-Significant Risk (NSR)
Which type of devices are exempt from pre-trial approval altogether?
Exempt
When are clinical trials conducted outside the US exempt from FDA approval?
When they are classified as Significant Risk (SR)
Which of the following is true about the gold standard for blood pressure measurement?
It involves inserting a catheter into the patient's artery
What is the purpose of comparing a new arm cuff blood pressure measurement to the gold standard?
To determine if the arm cuff is measuring accurately
What is the gold standard for a medical device?
An industry-accepted device that the new technology will be tested against
Which regulatory pathway is typically followed for a class 2 medical device with a substantially equivalent predicate?
The 510(k) premarket notification regulatory pathway
Which regulatory body approves medical devices for sale in the United States?
The FDA
What is the advantage of a nonsignificant risk classification for a medical device?
It allows for faster approval by an IRB
What is the average approval time for a de novo 510(k) submission?
8 to 16 months
What is the key aspect of business preparations for product launch?
Sales and marketing plan
Who is responsible for determining if a device is a non-significant risk in a clinical trial?
The clinical trial sponsor
What happens if any one of the IRBs determines that the device is a significant risk in a clinical trial?
The company must seek IDE approval from the FDA
What information is required to be included in the IDE (Investigational Device Exemption)?
Information about the device and a US sponsor
What is the timeline for FDA IDE approval if the clinical trial will be conducted in the United States?
30 calendar days
Which type of medical devices generally do not require clinical trial data?
Class 1 medical devices
What is the purpose of clinical trials for medical devices?
All of the above
What is an IDE in the context of medical device clinical trials?
Investigational device exemption
What is the purpose of GCP guidelines in clinical trials?
To ensure patient safety and data accuracy
Which of the following is NOT a key factor for a successful product launch?
Building an adequate sales force
What is the importance of a reimbursement strategy for a product launch?
It expands the market for the product
What is the purpose of having sufficient quality and regulatory resources in place?
To respond to customer complaints
What does a careful plan for manufacturing ramp-up ensure?
Sales growth won't be constrained by manufacturing capacity
What should business preparations for a new device launch include?
Providing post-launch service and support
What is one of the challenges in selling a new medical device?
Building an adequate sales force
Test your knowledge on FDA device label requirements, sterilization processes, and stability studies in this informative quiz. Learn about the importance of data validation and how it supports a device's intended use.
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