Now that the 2015 UDI compliance date for labelers of Implantable, Life Supporting and Life Sustaining medical devices is past, Class II device labelers are next to face an FDA compliance date for UDI. Because of the huge number of Class II devices on the market in the U.S., Class II compliance is the biggest UDI challenge yet for the medical device industry. A lot of things need to come together for each labeler company in order to meet the FDA’s deadline of September 24, 2016.
To help Class II labelers get started in complying with the FDA’s UDI data submission requirements, we are excited to announce the launch of our new ebook, a Class II UDI Submissions Guide: Keys to Meeting the 2016 GUDID Compliance Date. The guide is intended to give you:
- Overview of the data required for submission
- Ideas for where that data may be currently stored in your organization
- Lessons we have learned as we helped dozens of device labelers implement successful UDI data compliance programs
- Additional resources for learning and getting started
The eBook is available for industry members to download at no cost on our website. Just click one the offer above to be taken to the page.
As always, if you have additional questions about UDI or need help getting started in your UDI submission efforts, please contact us and we will be happy to help.