US FDA Tweaks Direct Marking Rules In UDI Enforcement Delay

US FDA is granting additional leeway to companies on complying with the direct marking requirements of its Unique Device Identification Regulation. The agency has updated a guidance document first issued in January to further delay, or even lift, the direct marking UDI requirement in some cases, as long as the UDI can be determined via other means.

The original 2013 UDI regulation gave class I and unclassified devices that are not implantable, life-supporting, or life-sustaining until Sept. 24, 2018, to comply with standards on date formatting, labeling...