Although many in industry may be quick to view the UDI as only a “labeling rule,” the impact of this rule will have far broader implications and will likely necessitate both significant time and expense on the part of device firms.
The “unique device identifier” is an alpha-numeric code assigned by an FDA-accredited issuing agency (or, in the absence of such an agency, by the FDA) that allows the healthcare community and patients to access basic identifying information about a specific version or model of a medical device. The UDI information is required to be in both a plain-text format and a second format that can be read by automatic identification and data capture (AIDC) technology, such as a bar code, RFID tag, or near field communications (NFC).
The UDI consists of two parts: the device identifier and the production identifier. The device identifier is essentially static information. It includes the specific model or version of the device, and the name and contact information of the labeler (usually, the manufacturer). The production identifier contains specific manufacturing information. It includes, among several other items, the lot or batch number, expiration date, date of manufacture, and if the product is sterile.
The FDA provided this example of a UDI label:
The FDA listed the benefits of the UDI program as:
The UDI must be on both the device label and the package in which the device is distributed. When a multiple-use device is likely to be separated from its label, the device itself must be marked with the UDI. In addition, there are three other categories of devices that require UDIs to be marked directly on the device itself:
The Agency has carved out some exceptions within these categories, however, including bone cement, devices where the capital investment would be too great relative to the benefit of the UDI, and devices sold at retail.
With the new UDI rules, the FDA also gives us a new definition: “labeler.” In this context, a labeler is any person who causes a label to be applied or modified on a device with the intent that the device will be introduced into U.S. commerce without any subsequent replacement or modification of the label. It is the labeler’s responsibility to assure compliance with the UDI rules and maintain all records linking the device to its UDI.
The labeler will most often be the manufacturer, but could also be the specifications developer, reprocessors, convenience kit assemblers, repackagers, or relabelers.
Makers of combination products, convenience kits, and “multi” packs should be aware of special considerations affecting those products. For combination products, the primary “mode of action” is what determines whether the product requires a UDI. If the product is primarily a device mode of action, a UDI is required. If instead it is primarily a drug mode of action, the combination product itself does not need to be labeled with a UDI, but any device constituent would require a UDI. For convenience kits, if the kit contains service components, both the components and the kit require distinct UDIs. Finally, as mentioned above, for “multi packs” in which multiple devices are sold together within one package, both the package and each individual device within the package must bear a UDI.
Though far-reaching, the UDI rule is not absolute across the device industry. There are several categories of products that may not require a UDI, including:
The proposed rule establishes a Global UDI Database (GUDID), which would be an FDA-administered, publicly accessible database tracking all medical devices’ UDIs, including those that are no longer on the market. The labeler will be responsible for submitting the appropriate information to the GUDID.
This information to be provided includes, but is not limited to:
The finalized UDI rule was published on September 24, 2013. All Class III medical devices had to have a UDI one year after publication of the final rule, and data for those devices was required to be submitted to the GUDID database at that time. Class II devices must have a UDI three years after publication, and data on those devices also must be submitted to the GUDID then.
The schedule for implementation is as follows:
Immediately upon publication of final rule:
One year after publication (September 24, 2014):
Two years after publication (September 24, 2015):
Three years after publication (September 24, 2016):
Five years after publication (September 26, 2018):
(This information is available on FDA’s website in the “Proposed Effective Dates” table here)
Device firms would be wise to start addressing its requirements now to ensure adequate preparation for the rule’s various compliance stages.
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