On-Demand Webinar | UDI & GUDID Update with Jay Crowley
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Why the FDA Is Tightening UDI and GUDID Compliance
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.
What Labelers Must Ensure
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.
What You’ll Learn
- How the FDA is closing the gaps between Legacy Identifiers (NDC/NHRIC) and UPC alternatives, and where full UDI is now required on class II or III OTC devices.
- What it means now that UDI is part of routine inspections and import label screening.
- Which GUDID data elements must match across MedWatch forms, recall notices, and other FDA systems — and where labelers most often fall out of alignment.
- How to handle GMDN codes, end-dating, and the DI record elements critical for adoption.
- Answers to the questions USDM’s UDI consultants have been hearing most often from device labelers.
UDI and GUDID compliance is no longer a one-time submission exercise — it’s an ongoing data-integrity obligation. When the same device is described inconsistently across GUDID, premarket submissions, registration, and listing, the FDA notices, and now it’s checking during routine inspections and at the border. USDM’s view is that getting ahead of this means treating device data the way you’d treat any regulated record: complete, accurate, current, and consistent across every system. Strong data integrity in life sciences practices are what keep UDI submissions audit-ready instead of reactive.
Presenters
- Jay Crowley, VP of Medical Device Services and Solutions, USDM Life Sciences
FAQ: FDA UDI and GUDID Compliance
What changed on 24 September 2024?
The FDA closed the gaps between the use of Legacy Identifiers (NDC/NHRIC) and the UPC alternatives, requiring full UDI on class II or III OTC devices. The webinar walks through what this transition means for labelers in practice.
Is UDI now part of FDA inspections?
Yes. The FDA has made UDI part of routine inspections and import label screening, so UDI and GUDID accuracy is checked alongside other compliance activities rather than treated as a separate, one-time submission.
What does the FDA expect from my GUDID data?
The FDA wants device data to be consistent: the data submitted to GUDID should match the data in other FDA systems such as premarket submission, registration, and listing — as well as MedWatch forms (section D) and recall notices. Inconsistencies can trigger FDA notification.
What should labelers do about devices no longer in distribution?
Devices that are no longer commercially distributed should be properly end-dated, and GMDN codes in GUDID should remain active (not obsolete) even for commercially end-dated devices, per the requirements covered in the session.
How do I get ahead of FDA UDI enforcement?
Start by making sure the data elements critical for adoption — catalog number, full customer contact information, and an accurate, complete device description — are populated and accurate across all your DI records, and that everything aligns across FDA systems. A continuous compliance approach helps keep that data aligned over time rather than scrambling at inspection. If you’d like help, contact USDM.
Watch the on-demand webinar. Fill out the form above to access the video replay and hear Jay Crowley’s full update on the FDA’s UDI and GUDID requirements. To talk through your own UDI and GUDID readiness with USDM’s consultants, contact our team.