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.
- 26 Jul 2016FDA releases draft guidance on UDI form and content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
- 23 Jun 2016HIBCC is designated by the European Commission as a UDI Assigning Entity.
- 23 Jun 2016The Council of the European Union announced its agreement with the European Parliament to implement UDI.