More Resources Sought For Using Patient-Preference Data In US Device Reviews
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration's vision for the next Medical Device User Fee Act is to ensure the reliability and sustainability of the device review program, but it is also considering 'other components' not traditionally considered, such as how to get resources to include patient preferences in decision-making, the agency said in minutes of a recent MDUFA IV patient/consumer stakeholder meeting1.