I've got a sterile device whose shelf life of four-years is based on completed real-time package integrity studies. Right now we do not have temperature and humidity labeling on our product. In fact in our IFU we say "no special storage conditions are necessary". Usually, when customers ask, they are okay with this... That all changed when today we had a customer that wanted the labeling to include storage and humidity requirements. Before we embark on testing to establish a temperature and humidity range, I need to know: Is there a requirement for storage conditions to be on a sterile medical device package label?