GHTF Issues UDI Guidance

With the increased interest in Unique Device Identification (UDI) the Global Harmonization Task force (GHTF) issued a guidance document on developing a UDI that will satisfy international concerns. When a regulatory authority (such as a region or a country) develops a UDI system it will, when implemented, achieve a globally harmonized approach by following the principles in the GHTF guidance.

The guidance defines a UDI compromised of a Device Identifier (DI) and a Production Identifier (PI). The DI is a unique code specific to a model or version of a device, while the PI includes serial number, lot or batch number, expiration date, etc.

Under the guidance, a UDI System has three parts: a UDI developed to a global standard, application of the UDI to the device, and information in an accessible UDI database.

While the GHTF organization is principally by Study Groups, it also has Ad Hoc Working Groups. One of these, UDI Ad Hoc Working Group, issued the guidance document GHTF/AHWG-UDI/N2R3:2011 entitled Unique Device Identification (UDI) System for Medical Devices and issued on September 16, 2011.

The US has a UDI program operating in FDA. The President signed the law requiring UDI on September 27, 2007. The FDA has not issued UDI regulations.