FDA Finally Issues Unique Device Identifier Rule

Register now

The Food and Drug Administration has released a proposed rule to establish a unique medical device identifier, called UDI.

The long-awaited identifier, which Congress authorized in 2007 with renewed pressure from members in recent months to implement, is designed to better enable users to track devices and enable FDA to identify safety or effectiveness concerns quicker and better target recalls.

“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 product information for that specific device, such as the lot or batch number, the serial number and/or expiration date,” according to an FDA explanation.

Under the rule, the FDA will create a database containing a standard set of basic identifying elements for each specific device model, and will make most of the information publicly available.

Premier Inc., a provider alliance that has long championed the identifier, cheered issuance of the proposed rule but criticized "an excessively lengthy implementation timeline" that FDA has proposed. "Since we have already been waiting five years for UDI, patients can’t wait until 2019 to have confidence that the devices implanted in their bodies are safe and effective. Moreover, a long timeline is not in line with Congressional intent in the recently passed Food and Drug Administration Safety and Innovation Act, which called for a two-year implementation timeline for life saving and implantable devices."

The proposed rule, to be published within a week in the Federal Register, is here. Additional information on the unique device identifier is here.

For reprint and licensing requests for this article, click here.