What is Special about September 24, 2023 for the UDI System?March 28, 2023
The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. In addition, the final rule requires the submission of product information to the Global Unique Device Identification Data (GUDID).
FDA has been implementing the UDI system with different compliance dates for different types of medical devices to ensure a smooth implementation. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA. Most of the compliance dates have been passed. So, what is special about September 24, 2023?
The Transition from the Use of Legacy Identifiers on Device Labels to UDI
The September 24, 2023, date is specific to the enforcement policy described in the May 2021 FDA Guidance, which applies to the requirement that legacy FDA identification numbers should no longer be used on a device label or device package. Legacy FDA identification numbers refer to both National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers created using labeler codes previously assigned to device manufacturers by FDA. Once the device is required to bear a UDI, any NHRIC and NDC codes will no longer be permitted on the device label or device packaging. Firms can continue to include catalog numbers, inventory numbers, ordering numbers or other identification numbers on device labels and packaging. This transition does not apply to Class I devices that had a Universal Product Code (UPC). For Class I device, the UPC can serve as the UDI required by 21 CFR 801.20. See 21 CFR 801.40(d).
The Expiration Date of FDA UDI Alternatives: UDI-A160001 and UDI-A160002
The FDA has granted a variety of time-limited alternative requests since the publication of the UDI Rule. For the stakeholders who use UPC as their device identifier, UDI alternatives UDI-A160001 and UDI-A16002 will expire on September 24, 2023. Check out here and here to see if a device is classified with product codes included for these two alternatives. Devices can have both a UPC code and a UDI on their label and package.
Once UDI-A160001 and UDI-A16002 expire, devices previously using these alternatives must comply with applicable requirements of the UDI Rule, including placing a UDI to device labels and packages and submitting updated device information to the GUDID. FDA notes the following: “The FDA does not object to the continued use of the alternative for finished devices that are manufactured and labeled prior to September 24, 2023. Devices that are manufactured and/or labeled on or after September 24, 2023, cannot use this alternative.” (Emphasis added.)
Planning Now is a Good Idea
If a firm needs to remove NHRIC and NDC legacy identifiers or currently relies on UDI-A160001 and UDI-A160002, it would be wise to plan for the transition. It is not far off! If not already started, firms need to start soon to implement the UDI requirements. When a firm develops requirements for UDI, an important step is to determine if the products can utilize any of the existing general exceptions from the requirement per 21 CFR 801.30. Use the FDA’s resources to determine the best UDI implementation strategy.
The single-use device exception under 21 CFR 801.30(a)(3) and the convenience kit exception 21 CFR 801.30(a)(11) (see UDI Convenience Kits Guidance) may be useful in some cases. We recommend working with the issuing agency to determine if the NHRIC or NDC number may be used as part of a UDI code. In planning for UDI compliance, remember to determine if the product must bear a permanent marking per 21 CFR 801.45 (see UDI Direct Marking of Devices Guidance).
While the final UDI Rule allowed labelers to request an alternative to UDI compliance, the Agency emphasized that the time for extensions is over: “… the FDA does not intend to grant additional extensions to alternatives UDI-A160001 and UDI‑A160002 beyond September 24, 2023.”
Finally, as a general matter, every firm needs to make sure its supply chain stakeholders (e.g., retail stores, pharmacies, and payors) are ready for the UDI transition by September 24, 2023.