The second component is a publicly searchable database administered by FDA, called the Global Unique Device Identification Database, which will serve as a reference catalogue for every device with an identifier. No identifying patient information will be stored in this device information center.

The FDA plans to phase in the UDI system, focusing first on high-risk medical devices. Many low-risk devices will be exempt from some or all of the requirements in the final rule.

[See also: 5 heavy hitters take lead on UDI.]

Once fully implemented, the UDI system rule is expected to have many benefits for patients, the healthcare system and the device industry. It will enhance the ability to quickly and efficiently identify marketed devices when recalled, improve the accuracy and specificity of adverse event reports and provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion, officials say. It will also offer a clear way of documenting device use in electronic health records and clinical information systems.

"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used. In turn, this can promote safe device use by providers and patients as well as faster, more innovative and less costly device development," said Shuren.

FDA issued the proposed rule requesting input from industry, the clinical community and patient and consumer groups on July 10, 2012.

The UDI system builds on existing device industry standards and processes, Shuren said. The UDI system is a key component of the National Medical Device PostMarket Surveillance System proposed in September 2012.

In general, high-risk medical devices, Class III, will be required to carry unique device identifiers on their label and packaging within a year and this number and corresponding device information must be submitted to the new database. Manufacturers will have three years to act for most Class II – moderate risk – devices. Manufacturers of Class I devices not exempt from UDI requirements will have five years to act.

Included in today’s announcement is the publication of a draft guidance for manufacturers outlining how to submit information to the database.