Summer is ticking by and only 40 working days remain until the 24 September 2016 FDA UDI compliance deadline. This means that most Class II medical device manufacturers are either on the homestretch of their UDI implementation or engaged in a fire drill to complete everything in time. Regardless of which category you fall in, you should also be working on your post-submission UDI maintenance plan.
Many industry members are thinking, “But all we need to do is submit the data and then we are done!” However, organizations implementing UDI need to address UDI compliance as more than just a project with a start and end date. Consider it for what it must be to be effective and successful – a process in its own right, incorporated throughout your established quality management system (QMS).
Yes, UDI implementation is a project that must be managed to ensure budgets are not over-extended, tasks are completed, milestones are hit and timelines met, but UDI compliance is a process that needs to be sustainable and adapted to the regulations of markets outside the U.S.
Adding barcodes to labels, changing the date format and uploading information to the GUDID are all requirements, but alone they are insufficient to show compliance. True compliance requires significant changes to the QMS and involves understanding the impact and interaction of UDI on all processes, proactive integration of UDI into the QMS, and assigning of responsibilities for the post-submission guardianship of both the UDI processes and the GUDID data.
Post-submission compliance activities are frequently overlooked in the frenzy of UDI implementation. Activities to be considered include:
- Process for changing GUDID data after the 30-day grace period
- Process for capturing GUDID data attributes during product design & development
- Maintaining data to ensure consistency among all data sources
- Monitoring UDI regulations and requirements changes
- Monitoring UDI issues as part of the non-conforming material and corrective/preventative action (CAPA) processes
- Coordinating label changes and GUDID data changes
- Coordination of product enhancements and GUDID data changes
- GUDID account administration
- Managing GUDID and ESG technical requirements
Additionally, once the UDI labels are in distribution, ensure that your customers are aware of the change and that the data is available at AccessGUDID. This can serve as a great opportunity for the sales team to reach out to customers and for the marketing team to leverage UDI compliance as a sales tool.
Ensure your customer service team is prepared to answer or redirect questions related to the UDI barcodes and the GUDID data. Since your customers are counting on answers it is imperative to keep them in close communication.
Technical and service teams must also know how to use the UDI, when to capture it and where it belongs on the service records.
Finally, recognize your UDI implementation team for all of their hard work, frustration, patience and diligence. This is a complicated process and a difficult project to manage, but one that is necessary and will only become more critical in the future.
If you need help managing your UDI data and processes after submission, contact Reed Tech. The Reed Tech team of UDI experts will be happy to help you understand and meet the requirements for ongoing UDI compliance.
Lena Cordie is the founder of Qualitas Professional Services, LLC. She works with global medical device manufacturers needing consulting resources for implementing quality management systems, UDI compliance programs, documentation and project management. She can be reached at email@example.com.