The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule.
The guidance delivers a description of the two forms of a UDI, which include the easily readable plain-text form and the automatic identification and data capture (AIDC) technology form, and discusses the use of data delimiters and the order that data should be presented in the easily readable plain-text form of the UDI carrier.
“Unique device identifier” is defined as “an identifier that adequately identifies a device through its distribution and use by meeting the requirements of [21 CFR 830.20]” (21 CFR 801.3).
A UDI is composed of a device identifier (DI) and a production identifier (PI). “Device identifier” is defined as “a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device” (21 CFR 801.3).
“Production identifier” is defined at 21 CFR 801.3 as “a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured;
(v) For an HCT/P regulated as a device, the distinct identification code required by 21 CFR 1271.290(c) of this chapter.”
This document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements.