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Friday, September 20, 2013

FDA Finally Releases Unique Device ID Rule

by Nathaniel Weixel

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The Food and Drug Administration Sept. 20 finally released its plan requiring device manufacturers to put a unique device identification (UDI) on the label and packaging for most medical devices. FDA said it plans to phase in the UDI system, focusing first on high-risk medical devices within the first year. Many low-risk devices will be exempt from some or all of the requirements in the final rule. So depending on the risk of the device, labelers (usually manufacturers) will have from one to seven years to comply with the UDI system requirements.

The final rule has been a long time coming. UDIs were first required under a 2007 law, but it did not establish a deadline for FDA to issue a regulation. A law signed by President Obama in July established a schedule for issuing a proposed and final UDI rule, and the proposed rule was issued in the summer of 2012. Since then, interest groups, stakeholders and lawmakers have been putting pressure on the agency to release a final rule.

What hasn’t changed is the disagreement between manufacturers and patient groups over the implementation schedule. Some groups wanted longer deadlines, while others felt the agency was taking too long. But all stakeholders agree that a properly implemented UDI system will make patients safer. It will enhance adverse event reporting, and will make it easier to quickly identify recalled devices. It will also offer a way for FDA to document device use in electronic health records and clinical information systems, so physicians can identify if any of their patients are using a recalled device.
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