FDA IN THE NEWS – ISSUE NO. 36

Stories were few this past week, but they had a repeating theme, the role of the FDA is changing. For many, the news that the FDA is delaying mandatory replacement of the Steris System 1 is welcome, as many facilities rely heavily upon these machines to not only reprocess flexible endoscopes, but other heat labile devices. In a broader sense, the FDA has reviewed the 510k and premarket notification process and decided it needs modernization. This is a process that medical device manufacturers and healthcare providers need to pay close attention to. As the Steris System 1 situation demonstrates, the FDA is a key stakeholder in the delivery of healthcare with a great deal of influence on the industry.