On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking (the November 5 Guidance),” which supersedes the direct marking deadlines mandated by the January 16, 2018, guidance.
Under the Unique Device Identification System, labels of medical devices are required to include a UDI, unless an exception or alternative applies. The labeler is required to submit product information concerning the devices to the FDA’s Global Unique Device Identification Database (GUDID). Prior guidances set up phased implementation of the regulatory requirement compliance dates ranging from September 24, 2014, to September 24, 2020, depending on the classification of the devices. The November 5 Guidance sets forth the following new deadlines for this phased implementation, after which the FDA intends to enforce the requirements.
UDI Labeling, GUDID Data Submission, and Standard Date Formatting
|Type of Device||UDI labeling, GUDID data submission, and standard date formatting will not be enforced before:|
|Class I and unclassified devices, other than implantable, life-sustaining or life supporting devices (LS/LS), manufactured and labeled on or after September 24, 2018||September 24, 2020|
|Finished Class I and unclassified devices, other than implantable and LS/LS, manufactured and labeled on or after September 24, 2018||September 24, 2021|
UDI Direct Mark
Further, regarding the Class III, LS/LS, and Class II non-sterile devices manufactured and labeled prior to the established direct mark compliance dates, which remain in inventory, and device constituents of a co-packaged combination product or kit, “FDA does not intend to enforce UDI direct mark requirements when the device’s UDI can be derived from other information directly marked on the device.” To make this determination, FDA will consider catalog numbers, lot numbers and serial numbers. For devices manufactured and labeled prior to their applicable compliance date, this policy applies after the expiration of the exception in 21 CFR 801(1)(1).
Similarly, the direct mark requirements compliance date for Class I and unclassified devices, except the L/LS devices, is September 24, 2020. According to the November 5 Guidance, the FDA does not intend to enforce UDI direct mark requirements for those devices until September 24, 2022. This applies to sterile and non-sterile devices, as well as device constituents of a co-packaged combination product or kit. Further, after September 24, 2022, FDA does not intend to enforce UDI direct marking requirements for these devices that were manufactured and labeled prior September 24, 2022, that remain in inventory, when the device’s UDI can be derived from other information directly marked on the device.
Additional information concerning devices that are subject to direct marking can be found on FDA’s website.
The implementation of the UDI has certainly been complex. Hopefully, after implementation, there will be ability to adequately identify devices through distribution and use.
For More Information
If you have any questions about this Alert, please contact Frederick R. Ball, Carolyn A. Alenci, Moreshwar B. Vaze, Ph.D., any of the attorneys in our Life Sciences Group or the attorney in the firm with whom you are regularly in contact.
 21 CFR 801.30(a)(1) provides an exception for a period of three years. This expiration expired for class III and LS/LS deices. For class II devices, the exception will expire on Sept. 24, 2019.
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