Integrating the Voice of the Patient Into the Medical Device Regulatory Process Using Patient Preference Information.

Abstract

The US Food and Drug Administration is one of several US and global agencies making strides to incorporate patient preference information (PPI) into its decision making. PPI has been included in 5 completed medical device marketing decisions to date. Its usage is not more widespread because of uncertainty about how to design "fit-for-purpose" patient preference studies and a lack of standards for the choice of preference elicitation methods, among other reasons. To advance the application of PPI