We are nearing almost 3 years of the original publication of the UDI final ruling. What this means to medical device manufacturers is that we are just over a month away (September 24, 2016) for certain deadlines around Class III and Class II devices and packaging. Class III regulations due Sept. 24th: UDI required devices […]
Pragmatyxs SmartLabel (PXSL) wasn’t created for just improving print operators user experience on the manufacturing and labeling line. It was also created as a tool that can offer proper validation, record history and security. Pragmatyxs is constantly evolving PXSL to not only meet customer requirements but also to improve processes that organizations haven’t even thought […]
We have posted previously on the potential changes on the Nutrition Facts label. The Nutrition Facts label is one of the most commonly read and recognized labels in the U.S. While the overall design of the Nutrition Facts label will stay the same the content within the label will see some changes, here are some […]
We can all agree that safety is a top priority within a company; however, depending on the tasks at hand safety could be the highest priority. GHS (Global Harmonized System for Hazard Communication) was created as a solution for hazardous materials being handled between international boundaries using images to denote the products and the hazard. […]
The FDA has recently published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule provides the FDA with an administrative process for the destruction of certain drugs refused admission to the United States. Many of these drugs come into the United States via international mail. […]