In September 2013, the FDA published the Final Unique Device Identifier (UDI) Regulation, which we discussed in detail in one of our earlier blogs. UDI initiatives also are underway globally; the European Commission released a framework for a UDI System in April 2013 and the International Medical Device Regulators Forum (IMDRF) UDI Work Group issued a guidance document on UDI in December 2013.
Following the September 2013 publication, the FDA has recently published a further guidance on the Global Unique Device Identification Database (GUDID). This document is primarily intended for device labellers and provides further information for submitting data to the GUDID.
The UDI should be created and maintained by device labellers based on global device identification standards managed by FDA accredited issuing agencies. As of June 2014, there are three accredited agencies.
A UDI is required to appear on the label of every medical device and every device package unless exempt. This includes combination products that contain a device constituent part; convenience kits; on vitro diagnostic products; human cells, tissues and cellular and tissue based products regulated as devices; and stand-alone software. The UDI is composed of two parts:
- Device Identifier (DI) – a mandatory fixed portion of a UDI that identifies the labeller and the specific version or model of a device
- Production Identifier(s) (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a specific device
- Lot or batch number within which a device was manufactured
- Serial number of a specific device
- Expiration date of a specific device
- Date a specific device was manufactured
- For a HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290 (C)
The GUDID serves as the repository of key device identification information. It contains only the DI, which serves as the primary key in obtaining device information from the database. PI’s are not submitted to or stored on the GUDID; the GUDID contains only production identifier flags to indicate which PI attribute(s) are on the device label.
The guidance in full can be found here on the FDA website.