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Class II UDI Submissions: What you need to know, Pt. 2/2



This post is part two of a two-part series intended to provide you with the basic information you need to know about the UDI data submission process. You can find part one of the series here.

There is now less than one year for labelers of Class II medical devices to comply with the FDA’s final rule on Unique Device Identification (UDI). This includes the requirement to submit UDI records electronically to the FDA’s GUDID database.

Here are steps four and five for Class II labelers getting started on meeting the mandate:

4. Select a UDI issuing agency

One of the early steps in establishing a process for UDI data submission is to establish a relationship with one of the agencies that have been accredited by the FDA to issue Device Identifiers (DIs). The three accredited agencies are:

  • GS1

Each of these organizations has different advantages and pricing structures, so think carefully about your company’s situation and product portfolio before making the selection. Read our blog post on issuing agencies to help you learn more about this process.

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5. Decide how you will submit data to the FDA

You will need to develop a plan for how your company will submit UDI records to the GUDID when you reach that stage of the process. Since the method you choose for submission may influence the manner in which you collect your data, you should consider your approach before the time comes to actually submit your UDI records to the FDA.

There are four basic approaches to submitting your collected data to the GUDID.

  1. FDA GUDID Web Interface
  2. Develop or purchase installed software
  3. Use a cloud-based Software-as-a-Service (SaaS) solution
  4. Partner with an outsourced UDI submission services expert.

You can read about the pros and cons of each approach for different types of labelers in more detail here.

Reed Tech provides both SaaS and Outsourced Service solutions for device labelers working to meet the FDA mandate.

Having helped dozens of Class III and I/LS/LS device labelers successfully submit their UDI data records to the GUDID, we have one piece of advice to stress above all others for Class II labelers: Start working toward UDI compliance now. Nearly all of our Class III and I/LS/LS customers have told us that their UDI submissions were more complex, more time consuming and more challenging than they had anticipated.

To learn more about how Reed Tech UDI solutions can help organizations ensure accurate compliance in a timely manner, contact us today.

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