This is an important news item for two reasons: First, patient safety advocates are growing impatient with the FDA for taking way too long to announce a proposed rule and concrete timeline for setting up a mandatory unique identification system for medical devices. Two, please note the mention in this article of the presumed standard: GS1.
Once the FDA creates the requirement, it will ultimately be administered by a single organization such as GS1 and the data will be stored in a central warehouse…
In a general sense, this is an important development as well because it highlights the fact that a growing number of people are gaining a heightened interest and sense of urgency for the new medical device identification standard. We’re ready. GS1 is ready. Practitioners are ready. We happen to know that many of the biggest and best device manufacturers are well into the process of getting ready. We’re all in favor. We just need the FDA to act and it has been a long time since the Amendments Act of 2007 passed in October and included a requirement for the implementation of a unique identification system for devices. Missing from that Act– a specific rule and a real timelime. In support of the Advanced Patient Safety Coalition, and others, I’d like to add my voice to the cause by saying the time is now.
GHS and Regulatory Labeling Challenges in the New Era 
