FDA Issues Proposed Rule on Unique Medical Device Identification

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that, beginning one year after it becomes final, will require most medical devices distributed in the United States to carry a unique device identifier (UDI). In the Food and Drug Administration Amendments Act of 2007, Congress directed the FDA to develop regulations establishing such a system for medical devices.

Under the proposed rule, a UDI is a unique numeric or alphanumeric code that includes a device identifier and a production identifier. The device identifier is specific to a labeler (typically, the manufacturer) and device model. The production identifier includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.

The proposed rule requires the label of medical devices and device packages to include a UDI, with certain exceptions for alternative placement of the UDI and for particular devices or device types. Each UDI would have to be provided in a plain-text version and in a form that uses bar code, RFID, or similar technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices, such as implantable devices.

As part of the proposal, the FDA intends to create a database that will include a standard set of basic identifying elements for each UDI and to make most of the database available to the public so that users of a medical device can easily look up information about the device. Neither the UDI nor the FDA’s database will contain any information about who uses a device, including personal privacy information.

The FDA touts several potential benefits for the system once it is fully implemented, including:

• To allow more accurate reporting, reviewing, and analyzing of adverse event reports.
• To reduce medical errors by enabling health care professionals to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
• To enhance FDA’s analysis of devices on the market by providing a standard way to document device use in electronic health records, clinical information systems, claim data sources, and registries.
• To provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
• To secure the distribution chain, helping to address counterfeiting and diversion.

The proposed rule is subject to public comment for 120 days, after which FDA will review the comments and adopt a final rule. Any final rule would become effective in stages, over a period of seven years. One year after publication of the final rule, the label and package for class III medical devices must bear a UDI. Class II device labels follow two years later, and class I and unclassified devices follow two more years after class II. For devices that must be marked, the start date for class III devices is three years after publication of the final rule, with class II following two years later and class I and unclassified devices following two more years later.

The FDA’s explanation of the proposed rule and its text can be found here.