What is a UDI and the GUDID?
The Unique Device Identifier (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. On September 24, 2013 the Food and Drug Administration (FDA) established a UDI system that requires manufacturers to include both a plain-text version of the identifying data, and a version encoded using Automatic Identification Data Capture (AIDC) technology such as linear or two-dimensional bar codes, RFID tags, etc.
- 07 Sep 2016FDA extends UDI compliance date for Class II convenience kits and repackaged single-use devices
- 30 Aug 2016New Version of “Create a HIBC UDI & Bar Code” Utility Now Available
- 26 Jul 2016FDA releases draft guidance on UDI form and content
- 15 Jul 2016Medicare endorses unique identifiers for medical devices
- 01 Jul 2016HIN Distribution Files Available Online