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.
- 03 Jul 2017HIN Distribution Files Available Online
- 05 Jun 2017FDA Extends UDI Compliance Deadline for Class 1 Devices
- 26 May 2017FDA Posts New Webpage on Use of Symbols in Labeling
- 07 Apr 2017European Parliament Votes to Adopt Medical Device Regulation Proposal
- 03 Apr 2017FDA Grants UDI Extension for Soft Contact Lenses