Translational Pathways for Cardiovascular Devices – Session VII: Interventional Devices for Heart Failure – FDA Perspective – Ileana Pina Practice Quiz
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Question 1 of 3
1. Question
What is the minimum a new device for heart failure must demonstrate to satisfy regulatory and reimbursement agency requirements in the US?
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2. Question
In which of the following regulatory pathways can the FDA approve devices on an intermediate or surrogate endpoint?
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3. Question
Both the Minnesota Living with Heart Failure and the Kansas City Cardiomyopathy Questionnaires are approved by the FDA for evaluation of health status in clinical trials