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Draft Guidance on UDI Direct Marking of Devices

Thursday, July 16, 2015   (0 Comments)
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The FDA issued a draft guidance, “Unique Device Identification: Direct Marking of Devices - Draft Guidance for Industry and Food and Drug Administration Staff.” This document is intended to help medical device labelers and FDA staff understand the FDA’s requirements for direct marking of devices for unique device identification purposes.

A unique device identifier (UDI) is required to be directly marked on a device itself if the device is required to bear a UDI on its label, and is also intended to be used more than once and reprocessed before each use. Such devices are typically intended to be used for months or years. Because they are intended to be reprocessed and reused, they will likely be separated from their original labels or device packages bearing UDIs. Directly marking these devices with a UDI best assures adequate identification of such devices through distribution and use.

Interested persons may submit either electronic comments regarding this document to or written comments to the Division of Dockets Management (Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.). It is only necessary to send one set of comments. Identify comments with Docket No. FDA-2015-D-2245]. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at

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