Medical device makers will soon have to embed tracking codes on their products under a new rule announced by the Food and Drug Administration on Friday.

The rule will require a “unique device identification system (UDI)” that, once implemented, will provide a consistent way to identify medical devices.The FDA says the system has the potential to improve the quality of information in medical device adverse events reports, which will help it identify product problems more quickly, better target recalls, and improve patient safety.

The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product's lot or batch number, expiration date, and manufacturing date when that information appears on the label.

The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalog for every device with an identifier. No identifying patient information will be stored in this device information center.  Most of this information will be made 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 the database will not contain, any information about who uses a device, including personal privacy information.

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.

Once fully implemented, the system is expected to “provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion,” the FDA said in a statement.

The FDA issued a proposed rule, requesting public input on July 10, 2012. Under the final rule, high-risk medical devices (Class III) will be required to carry unique device identifiers on their label and packaging within one 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.

Accompanying the rule, the FDA has published draft guidance for manufacturers that outlines how to submit information to the database. A chart deaing compliance dates and deadlines can be found here.