The FDA July 3 issued a proposed rule on unique device identifiers (UDIs).

During a teleconference announcing the proposed rule, FDA Center for Devices and Radiological Health Director Dr. Jeffrey E. Shuren said that the proposal would serve as the “lynchpin” for a modern postmarket monitoring system for medical devices.

Under the proposal, the FDA said, with certain exceptions, a UDI would include (1) a device identifier, consisting of a unique numeric or alphanumeric code specific to a device model; and (2) a production identifier, which includes the current production information for a device (such as a lot number, batch number, serial number and/or expiration date).

The agency said that it was proposing “a risk-based phased-in” approach for implementing the rule, focusing on the highest-risk devices first. The FDA proposes exempting over-the-counter devices sold at retail. Shuren said that the UPC codes already in place for such devices can serve many of the purposes of a UDI.

The FDA is calling for comments on the proposed rule to be submitted within 120 days of publication of the proposed rule in the Federal Register. Under the FDA user fee legislation passed by Congress, Shuren said, a final UDI rule is to be issued within six months after the comment period on the proposed rule ends, with implementation of the final rule then taking place over several years. The UDI requirements would fully apply to the highest-risk devices within one year of the issuance of the final rule.

Shuren also said that the FDA has worked closely with foreign regulators in the Global Harmonization Task Force (GHTF) to establish an international standard for device identifiers, and that the proposed rule is consistent with the standard that the task force established for a “truly global” UDI. TheInternational Medical Device Regulators Forum, the GHTF’s successor, will work to harmonize implementation of device identifier rules, Shuren said.

Information on the proposal, including a link to the text of the proposed rule and a mockup of what a UDI would look like on a device label, is available online.

Full coverage of the UDI proposed rule will appear in the August issue of Thompson Publishing Group’s Guide to Medical Device Regulation newsletter.