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UDI Submission Load Testing

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UDI Traffic Jam As I talk to medical device industry members about their plans for UDI, I continue to find many organizations that have not yet begun making their submissions to the GUDID. A lot of labelers have collected their data, modified their labels and taken the other steps necessary to meet the FDA’s UDI mandate but are waiting to complete their GUDID submissions, thinking they have plenty of time now that the other steps are out of the way. They may be unpleasantly surprised, come August or early September, at the time required for this last step.

FDA is aware that the volume of Class II records will be a challenge as we draw closer to the September 24 deadline. Reed Tech and a few other organizations assisted FDA staff in load testing the GUDID system this month. All submissions made by Reed Tech received positive acknowledgements but results did indicate that high volumes received by the FDA can slow down the process considerably. The FDA has indicated it may engage in additional testing in the coming weeks.

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Keep in mind, the Electronic Submissions Gateway (ESG) handles all kinds of submissions to the FDA, not just UDI. In addition to the growth in volume of UDI record submissions, we should also anticipate a significant increase this year of adverse event reports and other types of submissions for both medical device and drug products. While the FDA is working hard to prepare for these increased volumes, labelers need to be aware that they will be competing with other companies for scarce resources. Our recommendation is to make your submissions to the GUDID as soon as possible to avoid the rush. You can help yourself by avoiding delays and headaches, as well as making things easier for the industry and the FDA as we all work together towards UDI implementation.

As always, if you have questions about UDI or need help preparing your records for submissions, please contact the team at Reed Tech.

Comments

  • Reed Tech

    Hi Rene,

    I hope this finds you well! I want to follow up on a comment you recently posted on a blog post hosted on the Reed Tech website. Your comment notes, “”UDI requires the device identification and production identification data to be printed separately and clearly.”
    Where does it say this in the final rule? And if you are asserting intent here, please explain what your definition of “separate” means.”

    Within the UDI Final Rule, FDA notes that the Unique device identifier is composed of,
    (1) A device identifier—a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
    (2) A production identifier—a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device.

    The UDI must be made available in both human readable and machine readable format and must meet the requirements set forth by the FDA issuing agency. The statement ” UDI requires the device identification and production identification data to be printed separately and clearly” is meant to illustrate the fact that the presence of the human readable production content on the label is not enough, it must also appear in a human readable, UDI Format.

    In addition, the issuing agency you choose to work with may have alternatives if you cannot fit both the Production Content and UDI-formatted content on the device label.

    Please do not hesitate to contact me directly with any questions you may have. You may reach me at hlentz@reedtech:disqus .com.

    Best,

    Haley Lentz