FDA Gives UDI Extension for Low-Risk Medical Devices

OMEDtechNews & Events

FDA Issues Letter to UDI Device Labelers

The FDA has provided a notice to device labelers with an update on the Unique Device Identification (UDI) compliance dates. Originally, the UDI was to be marked on labels at different time frames with regard to the classification level of the device. The FDA has extended UDI compliance dates for certain types of lower risk Class I and unclassified devices. This extension will allow the FDA to further develop the UDI system and gain the full potential of UDI data. The UDI label requirement for certain Class I and unclassified devices has been extended to September 24, 2020. The UDI direct mark for these lower risk devices will need to be in place by September 24, 2022. A new guidance document will be issued to provide information on the enforcement discretion for labeling, GUDID submission, standard date formatting and direct mark requirements for low-risk medical devices.