The primary objective of the Study is to advance the science of regulatory patient preference assessment, by giving medical device industry sponsors, regulatory agencies, and preference assessment experts another example of a disease-specific patient preference study. The intention is not to benefit any one heart failure (HF) therapeutic device or treatment. CDRH has expressed interest in understanding patient preferences in HF, given the size of the patient population and the breadth of available products and treatment options. Individual sponsors may choose to use the preference information gained from this study for their own commercial needs, including regulatory submission. However, the utility of the results of this study for commercial purposes is not the primary objective nor a guarantee of the initiative.
Current as of October 29, 2019