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Class II UDI Compliance Efforts: Smooth Sailing or Stormy Seas?


Earlier this month, Reed Tech UDI expert Gary Saner presented a webinar about how Class II device labelers can ensure smooth sailing through the process of submitting UDI records to the FDA’s GUDID database. (You can access the slides and presentation recording here.)

The submission process is a voyage through five stages, each with its own challenges and complexities:

1. UDI Project Prep
In this step, you create your UDI governance team for your company. It will research and identify FDA UDI requirements that pertain to your specific products and data. This group draws up and implements the UDI compliance plan.

2. GUDID System Prep
In this step, you evaluate the available GUDID solutions, select the one that best suits your organization’s needs and capabilities, and get it up and running.

3. GUDID Data Prep
Once the GUDID solution is in place, you need to populate it with your data. Do not underestimate the challenges and the time required to locate data from groups across your organization. Once you have found the data, it must be standardized and validated so it will move smoothly into the GUDID system. (In addition, systems should be set up so that any updates to that data will be reported to the central system.)

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4. Submit Data to GUDID
The submissions process has several steps and includes receiving acknowledgments and feedback from the FDA. You will need to carefully monitor that process so you can respond to any issues that arise.

5. Maintenance
GUDID submission is not a one-time effort. The team responsible for your submissions to GUDID needs to track internal data and then send updates to keep the GUDID database current. In addition, many organizations will need to prepare their systems to handle international UDI submissions.

Reed Tech currently works with more than 100 medical device companies and has helped customers submit more than 110,000 records to the GUDID.

To learn more about how Reed Tech can help you chart a course through smooth waters and avoid troubles on the journey, contact us today. We will be glad to help.

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