In 2013, the U.S. Food and Drug Administration (FDA) issued a final rule for a Unique Device Identification System to enable the rapid and accurate identification of medical devices throughout their distribution and use.
- Medical device labels and packages and, in some instances, the device itself must include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The UDI must be provided in both a human-readable plain text format (e.g., numeric or alphanumeric code) as well as a machine-readable format (e.g., bar code or radiofrequency identification). The UDI must also be directly marked on the device itself for reusable devices intended to be reprocessed before each use; this is to allow device identification in the situation where the device has been separated from its label and package. The UDI is to consist of two separate identifiers: a device identifier (DI) and a production identifier (PI). The DI is a portion of the UDI that identifies the fixed or non-variable information related to the device (e.g., the labeler and the specific device version or model), while the PI is a portion of a UDI that identifies the variable information related to the device also normally found on the device label (e.g., lot, batch, and serial numbers; expiration date; date of manufacture). Device labelers are to use an FDA-accredited issuing agency to build their UDI.
- Dates used on medical device labels must be formatted numerically as YYYY-MM-DD, which represents the four-digit year, followed by the two-digit month, followed by the two-digit day, each separated by a hyphen.
- Product information found in the DI part of the UDI must also be submitted to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. Information found in the PI part of the UDI is not submitted to the GUDID. In order to submit information to the GUDID, labelers will need to request a GUDID account. Account requests from labelers of class II medical device opened February 1, 2016. GUDID information can also be accessed by the public through the AccessGUDID database; this may be particularly useful for healthcare workers that want access to device characteristics for clinical decision support (e.g., MRI safety information, latex presence, device sterility status).