Today the FDA released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”. 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.

We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.

As a reminder and as noted in the UDI final rule, upcoming UDI compliance dates are:

  1. 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.

For more information about the Unique Device Identification (UDI) System, please visit the FDA’s UDI webpage.

If you have any questions, please contact the FDA UDI Help Desk.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health