Medical device labelers learned some of the basics about the unique device identifier (UDI) in a recent session held during the AAMI 2015 Conference & Expo in Denver. More information is now available as part of a draft guidance document scheduled for publication by the Food and Drug Administration (FDA) on June 26.
The final rule pertaining to UDI labeling, published on September 24, 2013, “requires a device bear a permanent UDI marking if the device is intended to be used more than once and intended to be reprocessed before each use. It details the UDI format when provided as a direct marking, and provides criteria for exceptions to this UDI direct marking requirement,” according to the new FDA guidance.
The FDA released the draft guidance document in an effort to “assist industry and FDA staff to understand FDA’s requirements for direct marking of devices” and to solicit “information on what processes should be considered to meet the definition of ‘reprocessing’ for purposes of UDI direct marking requirements.” In particular, the “FDA seeks additional information on its current definition of ‘reprocessing’” for items that are cleaned but not subjected to further sterilization or disinfection processes. Regulators also aim to determine “what public health benefits would be served by requiring a UDI direct marking to be affixed to devices intended to be reused for which reprocessing instructions include cleaning only and not disinfection and/or sterilization.”
The notice invites public comment for a period of 90 days from the date of publication. Interested parties may submit feedback and find more information at http://www.regulations.gov.