Unique Device Identification (UDI) of Medical Devices

New labeling mandates from the FDA, now expected to be imposed beginning in 2013, will require all healthcare product manufacturers in the United States to adhere to a uniform set of UDI labeling standards.

The Senate unanimously passed a bill (9/21/07) that includes a provision requiring the Food and Drug Administration (FDA) to put into place a unique medical device identification system. On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 included the requirement of a Unique Device Identification System. The UDI System is intended to assign a unique identifier to medical devices and other healthcare products. The goal is to establish a common set of rules for uniquely identifying devices which facilitate tracking their movement through distribution and use while providing improved patient safety with lower costs, improve recalls, reduce medical errors and provide product traceability.

Regulations were drafted in early 2009 followed by a period for public review. The FDA recently completed a pilot test of a prototype UDI database. The purpose of the pilot was to better understand and assess the feasibility and usability of a prototype Unique Device Identifier Database (UDI). In December 2010, the results of the FDA Pilot Activities study were released. This study was designed to explore the opportunities and challenges of implementing the Unique Device Identification System.

Expect more updates in the near future.