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FDA is Sharpening its Focus on UDI Data Quality


In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID.

In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira Konduri reminded medical device industry members to avoid common data quality errors and observe the agency’s best practices while submitting and maintaining GUDID records. Data quality, Konduri stressed, is essential for “realizing public health benefits and a return on investment across the entire healthcare ecosystem.” The industry is on a path to utilize UDI data at all stages of the device lifecycle, from “manufacturing through supply chain to patients, electronic health records (EHRs) and registries,” so data accuracy and completeness is essential.

In addition to asking industry members to pay increased attention to the quality and completeness of their data, the agency is taking several steps in coming months to help improve the quality of GUDID records:

  • Updating GUDID Data Element business rules to improve validation
  • Automating Email Notification to Labelers with records that have:
    • Incorrect GS1 GTIN Check Digits in “Device Identifiers”
    • Blank Device “Trade/Brand Name” Fields
  • Working with stakeholders to address specific issues
    • Define industry relevant Size metrics by Device Type
    • Avoid duplicate DIs for same Brand Name and Model/Version
  • Allow easier GUDID error corrections/updates
    • Allow edits of additional fields after the 30-day grace period
    • Reduce publication time of updated record to AccessGUDID

Konduri wrapped up her presentation to the DTA audience by passing on some requests from FDA to industry members:

  • Start with good data
  • Refer to the FDA’s GUDID Data Elements Reference Table
  • Provide complete information in your device record
    • If you have data for “optional” data elements, please provide it
  • Information in GUDID should match what is on the label of the device
  • After initial record submission, review within the 30-day grace period and make corrections
  • Please take advantage of upcoming GUDID enhancements to make corrections after the 30-day grace period

Additional Timing Details for System Enhancements

In an email to subscribers on February 16, 2018 the FDA gave more detail on the planned timing of upcoming GUDID enhancements:

Late March 2018: GUDID enhancement to allow labelers to make edits and updates to locked/fixed data attributes after the 30-day grace period. This functionality allows for faster edits and avoids the need to log an FDA Help Desk Ticket.

Summer 2018: Provide additional data values in GUDID downloads: FDA GUDID Record Version fields, Labeler DUNS Numbers, and Premarket Submission and Supplement Numbers. Inclusion of the Premarket Submission and Supplement Numbers will be based on confidentiality designations in the FDA Device Registration and Listing Module (FURLS). FDA advises submission owners to review and make updates if necessary.

What does this mean for industry members and downstream data users?

These changes to GUDID mean device labelers will have greater control over the content of their UDI records, even beyond the 30-day grace period. Updates, additions and corrections will be able to be performed much more quickly with less effort. However, labelers should understand that with this flexibility there are increased expectations surrounding data completeness and accuracy in the GUDID.

As a UDI data solutions provider, Reed Tech will be able to offer faster and more extensive support to its customers, helping them establish and maintain clean, accurate UDI records across their product portfolios. While FDA changes to validation procedures may require minor system updates, the payoff is clear.

In summary, these changes will require some time and effort but will be beneficial for labelers, technology providers, the FDA, downstream data users and, most importantly, for patients. They will help us realize the promise of the UDI initiative by ensuring the data used to track devices through their lifecycle is complete, accurate and up-to-date.

If you have questions about what this means for your organization, UDI in general or how to find help, please contact the Life Sciences team at Reed Tech.

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