With many device manufacturers struggling to implement challenging new UDI regulations, FDA has released a series of education modules to help clarify the law.
The five published modules range from basic material like information on UDI Systems, understanding applicable compliance dates and how to submit data to the Global Unique Device Identification Database (GUDID). Most of the modules include a slideshow and accompanying video. To access the education materials, click here.
The next UDI deadline is September 24, 2016, when class III devices will be required to bear a UDI as a permanent marking on the device itself if it is intended to be used more than once or be reprocessed before each use; labels and packages of class II medical devices must bear a UDI, and data for class II devices is required to be submitted to the GUDID database.
Those involved in UDI compliance realize that it means a significant undertaking from internal and external stakeholders. Prepare for the next deadline with these articles on the history, evolution and best practices behind UDI.
Brush up on the history and evolution of UDI:
- UDI: Where Do We Go From Here?
- UDI Implementation: What are Your Next Steps?
- UDI Update: Trays and Kits
- New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices
- UDI: Many Questions Remain
- FDA Publishes Q&A on UDIs
- Get Ready for UDI: It’s All About the Data