UDI
UDI refers to a government initiative, a Unique Device Identifier system for medical devices. On September 27, 2007, the Food and Drug Administration (FDA) Amendments Act of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification system. The new system when implemented will require:
- the label of a device to bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices.
- the unique identifier to be able to identify the device through distribution and use
- the unique identifier to include the lot or serial number if specified by FDA
The FDA continues to explore how a national UDI system should be structured and how it will improve patient safety, reduce medical errors, facilitate device recalls and improve device adverse event reporting.
For additional information please read the following 2-part series on UDI:
From
Information Silo to Bridge, Part 1: The State of UDI, Medical Device & Diagnostics Industry
From
Information Silo to Bridge, Part 2: Creating a UDI System, Medical Device & Diagnostics Industry
FDA Website on Unique Device Identification
AHRMM's correspondence to the FDA on the subject of Unique Device Identifiers
Letter to FDA Regarding UDI - July 2007
Letter to FDA Regarding UDI - November 2006
