FDA Focuses On Human Factors To Help Minimize Device Recalls
This article was originally published in The Silver Sheet
Executive Summary
FDA PRESSES MANUFACTUERS ON DEVICE USABILITY: Although the words "human factors" don’t appear in the Quality System Regulation, FDA is spreading the word that usability must be factored in when firms manufacture devices. In fact, the regulation’s preamble – which carries legal weight – points out that user-friendly design is necessary. Nevertheless, some experts say not all companies are taking human factors into consideration and consequently are paying the price by removing their products from the marketplace and spending additional money to redesign devices from scratch