Unique Device Identifier Rule Proposed by US FDA

The US Food and Drug Administration has published a proposed rule that would require medical devices marketed in the US to be assigned unique device identifiers (UDI). Setting up a UDI system would improve functions such as adverse event reporting and device recalls; the proposed system would incorporate UDI recommendations made by the Global Harmonization Task Force.

Each UDI will consists of an identifier specific to a medical device model, as well as a production identifier containing current production information including batch number, serial number and expiration date of a particular device. Most medical devices cleared or approved by the FDA will have to comply with UDI requirements if the rule goes forward.

The FDA also plans to establish a database, the Global Unique Device Identification Database (GUDID) that will store basic identification information for medical devices. This data will be publically accessible.

The FDA acknowledges the impact its proposed UDI system may have beyond just the US medical device market, as well. Given its influence and the size of the market it regulates, the FDA’s approach to UDI will likely shape how other market regulators develop their own UDI systems. “When fully implemented, the UDI system may … lead to the development of a medical device identification system that is recognized around the world,” the FDA states in its announcement of the proposed UDI rule. 

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