Translational Pathways for Cardiovascular Devices – Session VII: Interventional Devices for Heart Failure – FDA Perspective – Ileana Pina Practice Quiz

What is the minimum a new device for heart failure must demonstrate to satisfy regulatory and reimbursement agency requirements in the US?

In which of the following regulatory pathways can the FDA approve devices on an intermediate or surrogate endpoint?

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