The FDA recently finalized elements of its Unique Device Identification (UDI) guidance document that focus on setting up and managing accounts with the global UDI database, among other issues. The agency, however, has not yet finalized other sections of its Draft Guidance that cover the steps for creating and managing “device identifier” records.
FDA issued the Draft Guidance in September 2013 to explain the UDI database, wherein every device manufacturer is required to submit specific device identifiers for each of their marketed products. UDIs must be established and submitted to the database for Class III, high-risk devices by September 2014. Other implantable and life-supporting devices have another year after that, and the requirements will apply for remaining Class II devices (including hearing aids with wireless features) in September 2016 and for Class I devices (including hearing aids) in September 2018.
Under the rule, the label and packages of most medical devices will be required to carry a UDI that features both plain text and automatic identification and data capture (AIDC) technology. A UDI is a unique numeric or alphanumeric code that provides certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device. This information will be contained in a publicly available UDI database.
Generally, all devices including Class I devices will be required to comply with a device identifier requirement, which specifies the specific version, model, and manufacturer of the device. Under the regulations, Class II and III devices are also required to include production identifier information such as batch and lot numbers. Under the rule, the UDI must appear only on the device label and package in most cases, although certain limited types of devices will be required to have the UDI appear on the device itself.