FDA Alerts Device Manufacturers to GUDID Data Mismatch Issues

Author: Zillery Fortner

The US Food and Drug Administration (FDA) recently issued letters to device manufacturers concerning potential discrepancies in the Global Unique Device Identification Database (GUDID). The letters highlight mismatches between device establishment registration and listing records and the corresponding Unique Device Identification (UDI) information loaded into GUDID. This development has raised concerns among manufacturers and industry experts alike, prompting the need for swift action and clarification.?

Mismatch Issues in GUDID?

According to Sarah Fitzgerald, the US program manager for Emergo by UL, the consulting firm has observed numerous instances where the FDA letters were sent to device manufacturers, even those with valid exemptions. This has led to speculation that the FDA's review process may need to consider these exemptions when evaluating the GUDID database adequately. Fitzgerald suggests exempt manufacturers should still respond to the FDA to ensure compliance and avoid potential repercussions.?

Response Actions for Companies?

If a company receives one of these letters, it is crucial to take appropriate action to address the issue.??

1. Check if the company falls under any exemptions the FDA may have overlooked.?
2. If the company believes it is exempt, writing a letter to the FDA explaining the exemption status and ensuring clarity is advisable.?
3. If a problem is identified, the following steps depend on the nature of the issue:

• Updating the information for consistency should be relatively straightforward for data entry errors (minor inconsistencies, spelling).??
• If a company discovers that it is genuinely noncompliant with UDI requirements, it might need to request a new UDI from an FDA-accredited organization, update device labeling and register the new UDI in the GUDID database.??

Importance of Compliance?

The FDA has emphasized the importance of industry compliance with UDI requirements and GUDID. Compliance is crucial to achieving the potential benefits of UDI, such as reducing medical errors and strengthening the security of the global device supply chain. The FDA's issuance of these letters reminds device manufacturers of their responsibility to comply.?

Rectify Discrepancies in GUDID?

The FDA's recent letters about GUDID data mismatches have prompted device manufacturers to reevaluate their compliance status. Companies that receive these letters should carefully assess their exemption status and respond to the FDA accordingly. Additionally, prompt action should be taken to rectify any identified discrepancies in GUDID, either through minor updates or by following the longer process for genuine noncompliance. Adhering to UDI requirements and maintaining accurate GUDID records is crucial for successfully implementing the system and its associated benefits in the medical device industry.?

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