August 3, 2023
By Sarah Fitzgerald
Background on Q2 FDA GUDID compliance letters
As reported June 9, 2023 , a few months ago, the US Food and Drug Administration (FDA) began sending out system-generated emails when the agency determined there was an apparent discrepancy between the company’s device listings and Unique Device Identification (UDI) information on the Global Unique Device Identification Database (GUDID). These letters did not appear to consider if there might be an exception from UDI that applied for the relevant device(s), such as if the device was Class I and exempt from good manufacturing practices (GMP) requirements.
Emergo by UL guidance on FDA GUDID letters
Emergo by UL advised that any company receiving such a letter first review their situation to see if there are gaps, and then take the appropriate action, which might range from updating the device listings and/or GUDID databases to obtaining appropriate UDI numbers and setting up a GUDID account. Although the FDA letter made it clear that an organization already in compliance did not need to reach out to the FDA, we advised that companies whose devices were exempt should reach out to explain the situation and why it is not relevant to meet UDI and GUDID requirements to ensure that the FDA knows that you have reviewed the information and are not out of compliance. It is always important to take FDA communications seriously.
FDA response to manufacturers' responses
We have become aware that in response to companies contacting the FDA regarding GUDID, the regulator is often sending out a form letter. In that letter, the FDA essentially lists several of the potential exceptions, and states that if the company and/or devices (as relevant) meet one or more of those exceptions, than no further follow-up with the FDA is necessary. Instead they recommend ensuring there is appropriate documentation. The exceptions noted by the FDA in this letter include:
- If the establishment does not meet the definition of a Labeler (21 CFR 801.3)
- If the device(s) in question are Class I GMP exempt (21 CFR 801.30(a)(2))
- If the device is an exempted consumer health product, in alignment with FDA guidance.
The FDA provides actions that can be taken, including ensuring that the GUDID and device listing information is correct and making any necessary updates, which may include populating the “Commercial Distribution End Date.” They note that for additional assistance or questions regarding this response to reply directly to their email response, or for other UDI-related questions to contact the FDA UDI Help Desk.
Additional Emergo by UL guidance to manufacturers
If you receive an initial letter from the FDA indicating that there is an apparent discrepancy in device listings and GUDID information, it is important to review your situation and take appropriate action, which may include updating the device listing and/or GUDID information. Although not required, if an exemption applies, Emergo by UL recommends reaching out to the FDA to explain why you are exempt, as this helps demonstrate that you have reviewed the FDA’s concern. As is typical within a medical device company, it is important to document your review of any apparent discrepancies and, if applicable, any actions taken.
If you receive an FDA response letter after letting the FDA know that you believe yourself exempt, then we do not recommend any further action other than documentation. Of course, if you have questions, need additional assistance, or otherwise feel a need to follow-up with the FDA, that can be done, as described in the FDA letter. If you want assistance, you can also contact Emergo by UL and our US FDA medical device regulatory experts can address your UDI questions and concerns.
Sarah Fitzgerald is Senior Consultant, Quality and Regulatory Affairs at Emergo by UL.
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