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 […]
Barcodes play a huge role in product labeling, reducing errors, expediting movement through the supply chain, inventory management and point of sale. Barcodes are the lifeline for product labeling; they hold vital information content whether it be how the product is handled, how it is inventoried or where it needs to be shipped. Many organizations […]
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. […]
The FDA is continually looking to improve not only the safety of food and drug manufacturing but also to provide a clear understanding of these products to consumers. The FDA is proposing manufacturers implement labeling changes that identify natural sugars and those added. While including the amount of natural and artificial sugars in a product […]