FDA-UDI final rule announced

Sept. 20, 2013

Baltimore, September 20 — Jay Crowley, Senior Advisor for Patient Safety, Center for Devices and Radiological Health, Food & Drug Administration (FDA) and UDI Regulation Lead. announced at 8:45 AM EST, Sept. 20, 2013, the final ruling on UDI Regulation and Guidance. The announcement was made at the 5th Annual FDA-UDI conference in Baltimore.

Summary: The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify 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 labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. 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. 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 identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow FDA, health care providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.

FDA has been working on this ruling since 2007.

To view the Final UDI Regulation, visit the Federal Register:


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