GS1 Healthcare US, a supply chain standards development organization, has issued guidance for using the standards when implementing the new Unique Device Identification requirements for medical devices.
In general, a final rule published in September 2013 requires the label on medical devices to include a UDI, with some exceptions or alternative placement depending on characteristics of a device.
The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology, according to the rule. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
The guidance from GS1 Healthcare comes as the first device-labeling compliance date of Sept. 24, 2014 looms, with four other compliance deadlines between then and September 24, 2020. For the first deadline in 2014, labels and packages of class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. A one-year extension of the compliance date may be requested no later than 270 days after the rule is published. Class III standalone software also must have an UDI.
The 54-page guidance document covers such areas as:
* Assigning, encoding and storing Global Trade Item Numbers, which can be used as the UDI;
* Defining and encoding GS1 application identifiers for UDI production identifiers, including serial number, batch/lot, production date and expiration date; and
* Encoding GS1 barcodes for automated identification and data capture.
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