US FDA Looking Into Medical Device Registrants’ UDI, GUDID Compliance

By Sarah Fitzgerald

The US Food and Drug Administration (FDA) has recently begun emailing letters to medical device registrants pertaining to Unique Device Identification (UDI) compliance and listing requirements.

The letters specifically regard an apparent discrepancy in device listings and UDI information loaded into the agency’s Global Unique Device Identification Database (GUDID). In these letters, FDA notes that the required compliance date for UDI on labels and in GUDID was before or in 2022.

While UDI information is now required to be uploaded to GUDID for the majority of devices, there are exemptions and alternatives. It does not appear that these exemptions have necessarily been considered by FDA in determining how to send out these system-generated emails. This means that companies may receive these letters even when everything that requires loading in GUDID has been completed.

In accordance with FDA regulation and decisions, the following products are among those exempted from UDI and GUDID requirements:

• A Class I device that is exempt from good manufacturing practices (GMP exempt) (21 code of federal regulations [CFR] §801.30(a)(2))
• Custom devices (21 CFR §801.30(a)(5))
• Devices intended only for export from the US (21 CFR §801.30(a)(8))
• Devices for which the FDA has established a performance standard that states an exemption to §801.20 compliance (21 CFR §801.30(a)(10))
• Most combination products with a national drug code (NDC) (21 CFR §801.30(b))
• Most Class I, 510(k)-exempt devices sold directly to consumers / patients which are labeled with a universal product code (UPC) (2022 UDI Guidance Document)

Additionally, it should be noted that in many cases, multiple companies in a supply chain must register their establishments and list their device with the FDA. For example, a specification developer, contract manufacturer and complaint file maintenance establishment are all required to register and list devices. However, there only needs to be one UDI and GUDID entry for these devices.

Are you meeting US FDA UDI and GUDID requirements?

So what should you do if you receive one of these letters from the FDA?

• Check if your devices meet the various exemptions.
• Determine if there is an agreement with another company in your supply chain that they handle the UDI and GUDID requirements.
• Determine if all of your devices are listed in the FDA GUDID database and are appropriately listed in the FDA device listing database.

If your company meets any of these conditions for all of your devices (in any combination), reach out to the FDA (preferably at GUDIDsupport@fda.hhs.gov) to explain the situation and why it is not relevant for you to have GUDID registration so that the agency knows that you have reviewed the information and are not out of compliance.

If it appears the listing discrepancy is real, you will need to update your device listings and/or your GUDID account, as appropriate. If your company does not yet have a GUDID account, you can register for one.

If you are having problems or questions, you can email to the FDA. 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.