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An Update on the FDA’s UDI and GUDID Compliance Requirements

On-Demand Webinar | UDI & GUDID Update with Jay Crowley

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As we near the 10th anniversary of the publication of the FDA’s UDI System regulation, the FDA is taking several steps to close existing gaps and improve the utility of UDI and the accuracy of the data in GUDID.  Specifically, as of 24 September 2024, FDA is closing the gaps between the use of Legacy Identifiers (NDC/NHRIC) and the UPC alternatives (full UDI required on class II or III OTC devices). More importantly, the FDA has made UDI part of routine inspections and import label screening.

This requires labelers to ensure the following.

  • The data submitted in MedWatch forms (section D) and in recall notices matches the data in GUDID.
  • The GMDN codes in GUDID are active (not obsolete) – even for commercially end-dated devices.
  • Devices that are no longer commercially distributed are properly end-dated.
  • The data elements critical for adoption are populated and accurate for all your DI records – including catalog number, full customer contact information, and an accurate and complete device description.

Ultimately, the FDA wants the data about a device to be consistent. The data submitted to GUDID matches the data in other FDA systems (e.g., premarket submission, registration, and listing).  You will hear – or maybe you already have heard – from the FDA if there is data inconsistency.  The data must align across all systems.  Now is the time to get ahead of the FDA’s UDI compliance activities.

This on-demand webinar provides an update on the FDA’s requirements and notification activities and aims to answer many of the incoming questions our UDI consultants have received recently.





On-Demand Webinar

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