Unique Device Identification System Final Rule
September 23, 2013
Dear Interested Party:
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), is pleased to announce the Unique Device Identification System Final Rule . This final rule is the first step towards a new and consistent way to identify medical devices throughout their distribution and use. By allowing for the identification of medical devices through distribution and use, this system represents a landmark step in our efforts to improve patient safety.
The UDI system comprises two core elements. First, the rule requires that a device bear a unique device identifier on its label and package, unless subject to an exception or alternative. The unique device identifier is a number or code that consists of two parts: the device identifier (DI) that is unique to a device’s version or model, and the device’s production identifiers (PI), which can include the device’s lot number, serial number, expiration date, manufacturing date, or other specific information. The second element of the system is the FDA-administered Global Unique Device Identification Database (GUDID) that will contain device identification information for each DI.
The system will be phased in over seven years, focusing first on the highest risk medical devices and eventually extending to most devices. (Key compliance dates are listed in the published rule.)
The UDI system is expected to have many benefits for patients, the health care system and the device industry. It will provide improved visibility as devices move through the distribution system up to the point of patient use and enhanced ability to quickly and efficiently identify marketed devices when needed for recalls and reporting and analyzing adverse event reports. It will also offer an unambiguous way of documenting device use in electronic health records, clinical information systems, claims data sources, and registries, potentially making available vast amounts of information for assessing the benefits and risks of medical devices.
The GUDID will contain device identification information and other attributes for each device subject to UDI. The FDA plans to make most of the data submitted to the GUDID available to the public. To support the use of the database the FDA has issued GUDID draft guidance for industry. (Please see the GUDID draft guidance for instructions on how to submit your comments to the FDA.)
It is important to note that there are operational aspects of the GUDID that have not yet been implemented. Material presented in the guidance reflects the current implementation of the database. Additional information will be forthcoming with subsequent releases of the GUDID.
The Center for Devices and Radiological Health (CDRH) has developed a CDRH Learn module that provides an overview of the UDI system. To stay current on opportunities to receive information from and communicate information to the FDA on UDI and GUDID, please subscribe to the UDI email update service and check the UDI website regularly.
We look forward to hearing from you as we work together to implement this critical system.
Final Rule - Unique Device Identification System Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry(PDF - 3.9MB) FDA finalizes new system to identify medical devices CDRH Learn video module: “UDI – The Final Regulation" Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps - April 2013(PDF - 289KB)