Translational Pathways for Cardiovascular Devices – Session II: Current Challenges and Future Direction for Aortic Valve Development and Iteration – FDA point of View Practice Quiz

Which of the following is consistent with label expansion?

Design iteration:

Methods of evaluation for indication expansion include:

Which of the following is correct regarding a nested registry?

Which of the following is correct regarding a physician – sponsored study?

Registries are used as a means for post market surveillance