Channeling Johnny Nash and the classic 1972 song, “I Can See Clearly Now,” on July 7, 2021, the Food and Drug Administration released its final guidelines titled, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI )). ”1 The final rule of the UDI system, which was published almost eight years ago, aimed to create a standardized identification system for medical devices that adequately identifies them during their distribution and use.2 The agency released draft guidelines five years ago. The FDA expects the guidelines, along with the final rule, to help FDA-accredited labelers and issuing agencies comply with UDI labeling requirements by clarifying the agency’s interpretation of certain stated requirements. in 21 CFR § 801.40.3
This bulletin summarizes some of the key provisions of the final guide and provides background information for the context.
- The UDI rule requires that the label and packaging of every medical device bear a UDI, unless an exception or alternative applies.
- Some devices are required to bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and to be reprocessed before each use.
- The UDI rule includes special labeling requirements for stand-alone software regulated as devices.
- The guide describes the two forms of an UDI (easily readable clear text form and Automatic Identification and Data Capture (AIDC) technology form), clarifies the content of the UDI, discusses the use of delimiters from data that identifies specific data elements in the UDI, and recommends the order in which the data should be presented in the easily readable clear text form of the UDI medium.
Unique Device Identifier (UDI)
- A “unique device identifier” is an identifier that adequately identifies a device during its distribution and use by meeting certain regulatory requirements.
- A UDI is a Device Identifier (DI) and a Production Identifier (PI).
- A “device identifier” is defined as “a mandatory and fixed part of a UDI that identifies the specific version or model of a device and the label of that device”.
- A “production identifier” is defined as a “conditional variable part of a UDI” which identifies one or more of the following when included on the device label:
- the lot or lot in which a device was manufactured;
- the serial number of a specific device;
- the expiration date of a specific device;
- the date on which a specific device was manufactured;
- for human cells, tissues and cellular and tissue products regulated as a device on the separate identification code.
- A UDI must be issued as part of a system operated by an issuing agency accredited by the FDA and comply with certain specific international standards incorporated by reference into the UDI Rule.
- The UDI on the device label and on the packaging must be provided both as easy-to-read clear text and as AIDC technology.
- AIDC is defined as any technology that transmits the UDI or the DI portion of a UDI from a device in a form that can be entered into an electronic patient record or other computer systems through an automated process.
- A “data delimiter” is a defined data character or set of data characters that identify specific data elements in an encoded data string represented in the UDI carrier.
- Data delimiters are used to identify information immediately following it, and data delimiters vary depending on the UDI system established by each agency accredited by the FDA.
- Data delimiters are important to the understanding and use of UDI and distinguish each piece of data in the data string represented in the UDI carrier.
- In the easily readable clear text form of the UDI medium, the UDI must precede any non-UDI element.
- The DI should go first, followed by the PI, if applicable.
- The guide included a new section providing recommendations for labeling requirements for stand-alone software.
- The FDA suggests that, for stand-alone software that is not distributed in packaged form, UDI labeling requirements be met if the UDI is provided via an easily readable clear text statement displayed each time the software is started or a Easily readable plain text statement displayed via a menu (or both).
- The agency adds that PI must also communicate the version number of the stand-alone software.