Food, Drug & Device Law Alert - 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...