FDA has released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”. The document is intended to help medical device labelers and FDA staff in understanding the FDA’s requirements for direct marking of devices for unique device identification (UDI) purposes.
A unique device identifier (UDI) is required to be directly marked on a device, if the device is required to bear a UDI on its label, and is 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.
The final UDI compliance dates are:
1. for Class I, class II and unclassified implantable, life-sustaining or life-supporting devices have a UDI labeling and GUDID submission compliance date of September 24, 2015.
2. All life-sustaining or life-supporting devices have a UDI direct mark compliance date of September 24, 2015. Please note: Implants are not required to be directly marked.
detail information about the Unique Device Identification (UDI) System, can be found on FDA’s UDI webpage..
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