FDA Limited In Its Ability To Prevent Unsafe Device Designs
This article was originally published in The Silver Sheet
Executive Summary
ENSURING USER-FRIENDLY DEVICE DESIGN is not always easy for FDA, especially when it comes to products approved through the 510(k) process. Brushing up against some of the gray areas in premarket review laws, agency reps explain their thinking, practices – and questions – on the topic of device usability. Human factors experts say industry has come a long way toward improving device designs to reduce the potential for use errors and resultant patient injuries and deaths. Nevertheless, recalls and adverse event reports suggest more could be done. Abbott and Medrad describe their human factors engineering efforts