On September 24, 2013, FDA passed the Final Rule for Unique Device Identifiers (UDI). With some exceptions, the regulation mandates that all medical devices must bear a UDI, which must be issued by FDA or an FDA-accredited issuing agency. FDA or the accredited agency will work with the Labeler (defined here as the person who finally labels a device, or as the person who replaces or modifies a device label, before commercial distribution) to develop the UDI, ensuring that it is properly constructed. Each version, model, labeling change, or packaging change for a device will require a new UDI. Once a Labeler has a UDI for a device, the Labeler must report information about its devices in the Global Universal Device Identifier Database (GUDID).
A UDI is a unique numeric or alphanumeric code that adequately identifies a device through its distribution. A compliant UDI is composed of two parts: a Device Identifier (DI), which identifies the labeler and the specific version/model of the device, and a Production Identifier (PI), which identifies the device by production (such as lot/batch number, serial number, expiration date, manufacture date, etc.). To standardize these identifiers, the new regulation requires that all dates conform to a universal date format (YYYY-MM-DD).
When fully implemented, the UDI system will:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports
- Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device
- Enhance analysis of devices on the market by providing a standard and clear way to document device use
- Support premarket approval or clearance of new devices and new uses of currently marketed devices
- Allow industry members to more effectively manage medical device recalls
- Provide a foundation for a global, secure distribution chain
Labelers of Class III devices and HCT/P devices must comply with the new regulation by September 24, 2014. Compliance for Class II and Class I devices will follow shortly. Implementing this change will be complex, and will require a lot of preparation and attention to detail. Get ahead of the curve! Contact us today to find out more about the UDI regulations.
