The U.S. Food and Drug Administration (FDA) has released a proposed rule that most medical devices distributed in the United States carry a unique device identifier (UDI). Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices. A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number, and/or expiration date.
A UDI system has the potential to improve the quality of information in medical device adverse event reports, which the FDA said will help identify product problems more quickly, better target recalls, and improve patient safety.
The FDA said it is also creating a database that will include a standard set of basic identifying elements for each UDI, and will make most of it available to the public so that users of a medical device can look up information about the device. The UDI does not indicate, and the FDA’s database will not contain, any information about who uses a device, including personal privacy information.
The requirements for device labels and device packages to bear a UDI would be phased in over several years. UDI labeling requirements will take effect for class III devices and devices licensed under the Public Health Service Act one year after the final rule is published. UDI labeling requirements will take effect for class II devices three years after the final rule is published. UDI labeling requirements will take effect for class I devices and devices not classified into class I, II, or III five years after the final rule is published. Most O&P devices are considered class I.
In developing the proposed rule, the FDA said it worked closely with industry, the clinical community, patient and consumer groups, and conducted four pilot studies.
To read the proposed rule and for instructions on how to submit electronic or written comments, visit the FDA’s website.