On July 10, 2012, in response to requirements in legislation that passed Congress with broad bipartisan support, the Food and Drug Administration published a proposed rule that would require most medical devices distributed in the United States to carry a unique device identifier, or UDI, except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device (e.g., devices sold over-the-counter and low risk devices). Each UDI would be required to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI also would be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient (e.g., those that remain in use for an extended period of time and devices that are likely to become separated from their labeling). The proposed rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use. Comments will be accepted on the proposed rule until November 7, 2012.
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FDA proposes unique device identification system for medical devices
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