Provide for More Rapid, More Efficient Resolution of Device Recalls. Delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced or eliminated.
Better Focused and More Effective FDA Safety Communication. By citing UDIs,
In addition, while not required,
Standard Format for Dates Provided on a Device Label. The rule will also better ensure dates on device labels are not confusing or misleading to users thereby ensuring the safe use of devices, by requiring that dates on medical device labels conform to a standard format consistent with international standards and international practice--year-month-day (e.g., 2013-09-30). This will ensure dates on medical device labels are unambiguous and clearly understood by device users.
Summary of the Major Provisions of the Regulatory Action in Question
This rule will require the label and device packages of medical devices to include a UDI, except where the rule provides for an exception or alternative placement. Each UDI must be provided in a plain-text version and in a form that uses AIDC technology. The UDI will also be required to be directly marked on a device that is intended for more than one use, and intended to be reprocessed before each use. The rule requires the submission of information concerning each device to the new GUDID.
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