FDA - HUD Flashcards
What does FDA stand for?
Food and Drug Administration
True or False: The FDA regulates all medical devices in the United States.
True
What is the primary purpose of FDA regulations on device studies?
To ensure the safety and effectiveness of medical devices.
Fill in the blank: The FDA categorizes medical devices into ___ classes based on risk.
three
What are the three classes of medical devices according to the FDA?
Class I, Class II, Class III
Which class of medical devices is considered to have the highest risk?
Class III
Multiple Choice: Which type of device typically requires premarket approval (PMA)?
A) Class I
B) Class II
C) Class III
C) Class III
What is a 510(k) submission?
A premarket submission to demonstrate that a device is safe and effective.
True or False: Class I devices are subject to the least regulatory control.
True
What is the main difference between Class II and Class III devices?
Class II devices require special controls for safety and effectiveness, while Class III devices require premarket approval.
Fill in the blank: The FDA requires that clinical studies for Class III devices must demonstrate ___ before approval.
safety and effectiveness
What is the role of Institutional Review Boards (IRBs) in device studies?
To review and approve the ethical aspects of clinical trials.
Multiple Choice: Which of the following is NOT a requirement for a 510(k) submission?
A) Device description
B) Clinical data
C) Manufacturing process
C) Manufacturing process
What does PMA stand for?
Premarket Approval
True or False: All medical devices require clinical trials prior to FDA approval.
False
What is the significance of the De Novo classification process?
It allows for a new device to be classified as Class I or II when there is no existing predicate device.
Fill in the blank: The FDA’s guidance documents provide ___ for device sponsors.
recommendations
What is the purpose of post-market surveillance for medical devices?
To monitor the safety and effectiveness of devices after they are on the market.
Multiple Choice: Which of the following is a requirement for Class II devices?
A) Premarket Approval
B) 510(k) submission
C) No regulatory oversight
B) 510(k) submission
What is an Investigational Device Exemption (IDE)?
An exemption that allows an investigational device to be used in a clinical study.
True or False: The FDA can impose penalties for non-compliance with device regulations.
True
What is the purpose of the FDA’s Medical Device User Fee Amendments (MDUFA)?
To provide funding for the FDA’s device review process.
Fill in the blank: The FDA’s regulatory framework aims to protect public health while fostering ___ in medical device innovation.
innovation
What is the significance of labeling requirements for medical devices?
To provide necessary information for safe and effective use.
