Direct Part Marking in Medical Device Applications • FDA UDI for Class 2 reprocessed (reusable) devices with direct marking is Sept. 24, 2018 deadline (Class III device deadline was Sep. 24, 2016) • 21 CFR 801.45 requires a “UDI direct marking” on a device subject to UDI labeling, if the device is intended to be used more than once and intended to be reprocessed before each use, such as surgical instruments. In general, UDI direct marking should include both the DI and PI information • FDA Guidance for UDI when using DPM issued in Nov. 2017 є Devices already labeled and shipped are exempted for 3 years from deadline date of that class device.
For Class 2 devices it means that existing direct marked items already in use are exempt until Sept. 24, 2019. Human readable info is not required in addition to the direct part mark. є FDA expects that records will indicate whether a device is directly marked and, if so, whether the direct mark DI is the same as or different from the primary DI. Source: FDA Unique Device Identification: Direct Marking of Devices Guidance for Industry and Food and Drug Administration Staff, Nov. 17, 2017