Lawmakers Question Whether FDA Will Finalize UDI Rule by Legal Deadline

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By Nathaniel Weixel  


A group of House Democrats in an April 25 letter questioned whether the Food and Drug Administration will be able to finalize its rule establishing a unique device identification (UDI) system by the statutory deadline.

The letter was signed by the co-chairs of the New Democrat Health Care Task Force--Reps. Allyson Schwartz (D-Pa.), Kurt Schrader (D-Ore.), and Bill Owens (D-N.Y.). The lawmakers said they were concerned about “recent public comments from FDA officials” that suggest the agency will not finalize the regulations by the May 7 statutory deadline.

Congress first required FDA to establish a UDI system in a 2007 law, but did not set a deadline for FDA to issue a regulation. The Food and Drug Administration Safety and Innovation Act (FDASIA), signed in July 2012, established a schedule for issuing a proposed and final UDI rule. FDA issued the proposed rule that month (6 MELR 442, 7/11/12).

“While FDA met its first FDASIA deadline [for a proposal], the agency--based on public comments--appears poised to miss the May deadline for the rule's finalization,” the Democrats said.

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.

FDA said it is proposing a risk-based, phased-in approach to UDI implementation, focusing on the highest-risk devices first and exempting low-risk devices from some or all of the requirements. FDA will begin to issue UDI tracking mandates for devices in 2014 and plans for the UDI system to be fully implemented for all high-risk devices by 2021.

FDA said that when fully implemented, UDI will enhance postmarket surveillance by improving the quality of information in medical device adverse event reports, which will help the FDA identify product problems more quickly, and better target which devices may be subject to recalls.

FDA on April 23 released a report on strengthening postmarket surveillance that includes finalizing the unique device identifier rule (see related item).

The lawmakers said, “The benefits of a UDI system can only be achievable after the FDA releases a UDI final rule … we urge the FDA to meet the statutory deadline for finalizing the UDI rule, which will enhance medical device tracking, and ultimately, improve patient care.”

By Nathaniel Weixel  

The letter is at