Podcast
Questions and Answers
Which acronym stands for Food and Drug Administration?
Which acronym stands for Food and Drug Administration?
- FDA (correct)
- PMA
- GCP
- BP
What does IDE stand for?
What does IDE stand for?
- Significant Risk
- Good Clinical Practice
- Investigational Device Exemption (correct)
- In Vitro Diagnostics
What is the purpose of a gold standard when testing a new device?
What is the purpose of a gold standard when testing a new device?
- To ensure that the device is safe for use
- To expedite the approval process
- To establish a benchmark for comparison (correct)
- To minimize the cost of clinical trials
What is the role of the FDA in medical device approval?
What is the role of the FDA in medical device approval?
Which type of medical devices require FDA approval and are classified as significant risk?
Which type of medical devices require FDA approval and are classified as significant risk?
What type of devices are classified as non-significant risk and require only IRB approval?
What type of devices are classified as non-significant risk and require only IRB approval?
Which type of devices are exempt from pre-trial approval altogether?
Which type of devices are exempt from pre-trial approval altogether?
When are clinical trials conducted outside the US exempt from FDA approval?
When are clinical trials conducted outside the US exempt from FDA approval?
Which of the following is true about the gold standard for blood pressure measurement?
Which of the following is true about the gold standard for blood pressure measurement?
What is the purpose of comparing a new arm cuff blood pressure measurement to the gold standard?
What is the purpose of comparing a new arm cuff blood pressure measurement to the gold standard?
What is the gold standard for a medical device?
What is the gold standard for a medical device?
Which regulatory pathway is typically followed for a class 2 medical device with a substantially equivalent predicate?
Which regulatory pathway is typically followed for a class 2 medical device with a substantially equivalent predicate?
Which regulatory body approves medical devices for sale in the United States?
Which regulatory body approves medical devices for sale in the United States?
What is the advantage of a nonsignificant risk classification for a medical device?
What is the advantage of a nonsignificant risk classification for a medical device?
What is the average approval time for a de novo 510(k) submission?
What is the average approval time for a de novo 510(k) submission?
What is the key aspect of business preparations for product launch?
What is the key aspect of business preparations for product launch?
Who is responsible for determining if a device is a non-significant risk in a clinical trial?
Who is responsible for determining if a device is a non-significant risk in a clinical trial?
What happens if any one of the IRBs determines that the device is a significant risk in a clinical trial?
What happens if any one of the IRBs determines that the device is a significant risk in a clinical trial?
What information is required to be included in the IDE (Investigational Device Exemption)?
What information is required to be included in the IDE (Investigational Device Exemption)?
What is the timeline for FDA IDE approval if the clinical trial will be conducted in the United States?
What is the timeline for FDA IDE approval if the clinical trial will be conducted in the United States?
Which type of medical devices generally do not require clinical trial data?
Which type of medical devices generally do not require clinical trial data?
What is the purpose of clinical trials for medical devices?
What is the purpose of clinical trials for medical devices?
What is an IDE in the context of medical device clinical trials?
What is an IDE in the context of medical device clinical trials?
What is the purpose of GCP guidelines in clinical trials?
What is the purpose of GCP guidelines in clinical trials?
Which of the following is NOT a key factor for a successful product launch?
Which of the following is NOT a key factor for a successful product launch?
What is the importance of a reimbursement strategy for a product launch?
What is the importance of a reimbursement strategy for a product launch?
What is the purpose of having sufficient quality and regulatory resources in place?
What is the purpose of having sufficient quality and regulatory resources in place?
What does a careful plan for manufacturing ramp-up ensure?
What does a careful plan for manufacturing ramp-up ensure?
What should business preparations for a new device launch include?
What should business preparations for a new device launch include?
What is one of the challenges in selling a new medical device?
What is one of the challenges in selling a new medical device?
