September 24th 2015 is upon us, thus the second deadline for UDI compliance has arrived. As a quick recap, the FDA is requiring all medical device product information to be submitted to their Global Unique Device Identification Database (GUDID) in order to more easily and accurately identify and trace medical devices along the supply chain. (You can find out more about the regulation and compliance deadlines here.)
Who needs to comply? All medical device manufacturers!
The deadline for Class III devices has passed and we’re already on to the second compliance deadline. As of Thursday, September 24, 2015 all medical devices meeting the following requirements need to be submitted to the GUDID.
- The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. Dates on the labels of these devices must be formatted accordingly.
- A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. Stand-alone software that is a life-supporting or life-sustaining device must provide contain a UDI.
- Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database.
With Class II and Class I compliance deadlines approaching in 2016 and 2018, respectively, your organization should start preparing by asking these critical questions:
- Have we determined the scope of products impacted?
- Are we sourcing data from multiple locations, formats and systems, controlled by different functions?
- Is our data complete and accurate for compliance?
If you answered yes to any of these questions, you should get started! In order to be ready for UDI compliance your organization will need to build specific and detailed strategies to meet your product information needs. Check out the 1WorldSync Guide to UDI to learn how to get your organization ready for compliance – and come back to the 1WorldSync blog for more informative posts on UDI and what your organization can do for advanced readiness! Have questions? Tweet me @ToddSimons1WS
- Have you started planning for UDI compliance? - April 6, 2016
- Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates - February 22, 2016
- The FDA wants YOU – to be compliant - September 23, 2015
- The Power of 1WorldSync Product Information Cloud - August 10, 2015