U.S. Food and Drug Administration (FDA) Unique Device Identification Rule
The FDA issued a “final rule” (September 24, 2013) to establish a system to adequately identify medical devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The UDI system went into effect in stages, over a period of seven years. Evergen has established a team to ensure compliance with the UDI rule within the specified timeframe. We have addressed some of the common questions below. However, if you have additional questions or need more information about the UDI transition, send your questions to Labeling@rtix.com.
What does the UDI rule include?
The label of a medical device is required to bear a UDI. Any date on the label that should be brought to the attention of the user e.g., expiration date, date of manufacture, must be presented in the format four digit year – two digit month – two digit day (e.g., 2024-09-24). Labelers are required to submit certain data about devices to the Global Unique Device Identifier Database (GUDID). The GUDID is administered by the FDA. Devices intended to be used more than once and reprocessed before each use are required to bear a permanent UDI affixed to the device itself unless an exception applies.
What is a UDI?
A UDI is a numeric or alphanumeric identification code assigned to medical devices by a labeler of the device. A unique device identifier is typically comprised of two segments; a device identifier (DI) and production identifier (PI):
A DI is a mandatory, fixed portion of the UDI that identifies the labeler and the specific model or version of the device e.g., Global Trade Item Number (GTIN)
A PI is a conditional, variable portion of the UDI e.g., lot number
Which RTI products are affected by the UDI requirements?
The UDI rule applies to all medical devices. Most of Evergen’s products are medical devices and subject to the UDI rule but most of the human tissue Evergen processes are not medical devices and the UDI rule does not apply.
Will the GTIN be used for traceability?
For those items labeled with a GTIN, the GTIN will accurately identify the model/ version number and the labeler of that particular item. For traceability, end users should capture the GTIN and the production data/ identifiers, applicable for the specific item in question e.g. serial number, expiration date, lot number.
When a customer places an order, will anything change?
Can a customer still use catalog codes?
Customers will continue to use Evergen catalog codes. There will be no immediate changes to packing slips and invoices.
What should customers do with existing Evergen inventory?
Do we need to send inventory back to Evergen for relabeling?
Devices that are in commercial distribution prior to the applicable compliance date do not have to comply with the final rule.
When was UDI implemented?
The UDI system went into effect in 7 stages. The final stage was completed on September 24, 2020. Various extensions and exceptions may be provided for different device classes.