GMP: New FDA Draft Guidance regarding Design Development of Medical Devices.
The goal of this guidance is to assist the medical devices industry in performing appropriate human factors testing on medical devices in order to reduce use error and injuries. The FDA hopes that the use of these recommendations will help prevent product recalls. Moreover, the guidance should also help control existing risks and reduce future ones.
The source of the news: http://www.gmp-compliance.org/eca_news_2686_7128,5817.html