The FDA is continuing to move forward with the UDI ruling as a way to identify a particular medical device within the United States. through distribution and use. The Unique Identifier will be used as a basis for reporting to enhance electronic tracking in the event of a recall in a timely and efficient manner.
A few of us recently joined a webinar, “Tips for Implementing FDA’s UID without Derailing Production” hosted by Chris Miller of Prisym ID, Jay Crowley, Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health, and Janice Kite of the GS1 Global Office. The webinar covers an overall view of what is happening and what to expect with the UDI ruling. Here is a copy of the webinar agenda:
- Gain an understanding of FDA UDI rule in practical terms
- Walk through the planned timeline for proposed FDA UDI regulations
- Evaluate the benefits of implementing bar-coding using GS1 standards
- Understand how labelling systems can remove the perceived complexities of FDA UDI regulations
- Learn how to implement UDI with minimal impact on your organization
Signed into law on September 27, 2007, it is expected that the FDA will implement proposed rulings this Fall with final ruling next year according to this group. The time to get onboard and prepare for implementation is now. This informative webinar explains why now, as well as how. You will need to register (it’s a short process) to view and listen to the full webinar. In my opinion, it was well worth the time.
Let us know what you think about the webinar, or questions you may have about UDI by leaving a comment below or email David Holliday.
Be sure to visit Labeling News by Winco ID regularly for news and events that relate to the FDA’s UDI ruling. If you want to get started in UDI compliance labeling or other ways to enhance your tracking and traceability, give us a call at 603-598-1553 or visit us at WincoID.com.