On November 5, 2018, 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,” deferring enforcement of direct marking deadlines. The new guidance, effective immediately, supersedes the guidance issued in January, previously discussed here. The guidance document is largely unchanged, other than with respect to direct marking deadlines, as noted below.
Despite the best intentions, and unsurprisingly for industry, the implementation of FDA’s UDI system has been exceedingly complex. As a result, FDA is prioritizing its enforcement of various deadlines. Specifically, FDA does not intend to enforce UDI direct mark requirements for Class III, life-saving or life sustaining, and Class II non-sterile devices that were manufactured and labeled prior to the UDI compliance deadline and remain in inventory, as long as the UDI can be derived from other information on the device. This can be through a catalog number, lot number, serial number, or something similar. FDA expects this information to be documented in the Global UDI Database (GUDID), which will be updated to include new fields to capture this information.
Although the direct mark compliance deadline for Class I and unclassified devices is September 24, 2020, FDA likewise does not intend to enforce UDI direct mark requirements for those devices until September 24, 2022. Moreover, as with the higher classification devices, FDA will not enforce UDI direct mark requirements for devices that are manufactured and labeled prior to the compliance deadline and remain in inventory, where the UDI can be derived from other information on the device.
With this enforcement policy, FDA has acknowledged that some devices can remain in inventory for relatively extensive periods of time, and has adjusted its enforcement expectations accordingly. The new guidance is effective immediately. Although FDA will accept comments through electronic submission at www.regulations.gov, there is no official comment period, and FDA is not required to address them.