FDA releases proposed rule on unique device identifiers

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The FDA has released a proposed rule that most medical devices distributed in the U.S. carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices.

A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, better target recalls and improve patient safety.

A UDI, a unique numeric or alphanumeric code, includes a device identifier specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The FDA is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and FDA’s database will not contain, any information about who uses a device, including personal privacy information.

In developing the proposed rule, the FDA worked closely with industry, the clinical community and patient and consumer groups, and conducted four pilot studies.

Read the Unique Device Identifier Proposed Rule here.