The FDA established the Unique Identification System (UDI) to identify medical devices sold in the US from the point of manufacturing and distribution all the way to patient use. The UDI final rule requires device labelers to: Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. […]
In January, “a 70-foot-long LauncherOne rocket was released from beneath the wing of a Boeing 747 carrier aircraft off the coast of Southern California, ignited moments later and soared towards space.” The intent by Virgin Orbit was to “deploy the nine CubeSats” into orbit. These small satellites were developed and built as part of an […]
The Safer Choice Program is a voluntary program in which companies are able to put the Safer Choice Label on their cleaning products but must invest heavily in “research and reformulation to ensure that their products meet the Safer Choice Standard.” This is a 40+ year program hosted by the U.S. Environmental Protection Agency (EPA) […]
Managing the requirements and following the guidelines when it comes to regulatory compliance labeling can be a challenge. Especially for organizations in the chemical, medical, and food & beverage industries. It’s become a higher priority for companies with adherence to strict and evolving policies that have placed additional demands for compliance labeling. Chemicals: Global harmonized […]
With manufacturing plant locations and distribution facilities operating globally, companies are seeing the benefits of developing a standardized global labeling approach. Pragmatyxs has been engaged in developing solutions for global label operations for many years. We have consulted with many organizations that have multiple plant locations in migrating from their own custom legacy labeling solutions […]
Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]
When it comes to making labeling work across global supply chains, many organizations have tried to meet their evolving needs through a variety of homegrown custom solutions. Such solutions may provide steps in the right direction, but they don’t get the job done adequately. These solutions can work to solve immediate challenges but are not […]
Here are some examples of the requirements for labeling in Food & Beverage Examples: The FDA’s Food Safety and Modernization Act (FSMA), aimed at preventing food contamination across every step of the supply chain, including use of imports and exports across international boundaries. FSMA also gives the FDA authority to order a mandatory recall of […]
With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US. The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class […]