HIBCC Guideline: Understanding FDA’s Proposed UDI Requirement
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. The proposed rule by the Food and Drug Administration (FDA) will establish a UDI system that will require 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.