FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements. For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI on their labeling.
The guidance is open to comment till September 24, 2015. Submit electronic comments on the draft guidance to regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
A copy of the draft guidance document can be found at Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments.
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