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 […]
In the barcode industry, there is considerable dialogue about (UDI) Unique Device Identification and (MDR) –Medical Device Regulation. We read and hear all about the initiatives and the deadlines, but why are these compliance requirements so important…. These compliance regulations provide for more accurate reporting, content review and the ability to report on device […]
The US Food and Drug Administration (FDA) is extending the deadline to comply with unique device identifier (UDI) requirements for certain Class II devices. The first mandate posted was that all Class II devices must be in compliance by September of 2016. Now, FDA says it is extending the compliance date for certain Class II […]
The European Commission (EU) announced its latest revisions to the proposed rule changes for unique device identification (UDI) requirements. The agreement has been in the development stage for the past year and the EU has now developed tighter rules for medical manufactures. These rules center on areas such as trace-ability and are designed to ensure […]
Paul Van Hout, Pragmatyxs CEO at Oracle Open World discussing the benefits of Oracle Cloud and how those benefits are utilized by Pragmatyxs.
Unique Device Identifier (UDI) The Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. A UDI system has […]
In the news…… U.S. Approves a Label for Meat From Animals Fed a Diet Free of Gene-Modified Products NY TIMES The Agriculture Department has approved a label for meat and liquid egg products that includes a claim about the absence of genetically engineered products. It is the first time that the department, which regulates meat […]
Jeremy Jellum has joined Pragmatyxs as a consultant on our Implementation and Support Team. Jeremy has over 3 years providing frontline support for Seagull Scientific’s BarTender labeling software and will be a valuable resource for our team and customers. Welcome aboard!
Seafood Labeling Law Signed in Washington State Wall Street Journal A law to help protect consumers from being victims of seafood fraud was signed into law this week in Washington state by Gov. Jay Inslee. The bill requires all fresh, frozen or processed fish and shellfish to be labeled by its common name as defined […]
In the news….. More from Whole Foods Market Genetically Engineered Foods Our goal at Whole Foods Market is to provide informed consumer choice with regard to genetically engineered ingredients (also known as GMOs or Genetically Modified Organisms). Clearly labeled products enable shoppers who want to avoid foods made with GMOs to do so. Accordingly, we […]