FDA's new rules for Unique Device Identification

The FDA published its new rules on the much-anticipated Unique Device Identification (UDI) today, which will see medical devices provided with uniquely identifiable information and data capture technology.

The eagerly awaited decision, which has been in the works since 2007, will require everything from bedpans and pace makers to cardiac stents and prostate specific antigen testing kits to carry both a unique identifier (in readable text) as well as automatic identification and data capture technology in the form of bar codes or radio frequency identification.

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The FDA will provide a Global Unique Device Identification Database, on which all UDI numbers and their relevant details will be stored. This database will be accessible to both members of the public seeking to know more about a device, as well as members of the industry.

The choice of automatic identification technology will be left to the device manufacturer, following extensive safety tests conducted by the FSA which has determined that radio frequency technology is safe to use with medical devices.

The initial system will simply capture basic details, such as the device’s make and model as well as the date and location of manufacture. In the future, however, there is the potential to track a device’s use and its journey through the supply chain.

Following the publication of the UDI ruling, the industry now has 120 days to provide feedback , after which the agency will have six months to provide the final rules. After this stage, there will be a phased-in implementation of the technology, where manufacturers of Class Three devices (those deemed to pose the highest risk to health and safety) must comply with the final regulations within one year. Class Two device manufacturer will have three years to meet the new requirements, and Class One manufacturers will have five years.

Under the new rules, medical device manufacturers much provide the identifiable information on the packaging or on the device itself if the device is likely to be removed from its packaging.