June 7, 2012

User Fee Bills Would End Unique Device Identifier Stalemate

From: The Regulatory Affairs Professionals Society

By Alexander Gaffney

A proposed rule by the US Food and Drug Administration (FDA) which would implement a so-called Unique Device Identification (UDI) system has been held up at the US Office of Management and Budget (OMB) for months, but could soon see rapid adoption under proposed user fee legislation in both the Senate and House of Representatives.

The UDI rule, mandated by the FDA Amendments Act (FDAAA) of 2007, is intended to establish a uniform medical device identification system able to be harmonized with rules being simultaneously developed in the European Union. Due to a legislative oversight in FDAAA, the rule was never given a date before which the rule needed to be implemented, creating a situation where OMB could legally delay the implementation of the rule for as long as it wishes to do so.

The rule has been deemed to be “economically significant” by OMB, and has been held up by its Office of Information and Regulatory Affairs (OIRA) since 11 July 2011 for reasons that are unclear.

While several pieces of legislation have been introduced to overcome the delays, including the Ensuring Safe Medical Devices for Patients Act proposed by Senator Jeff Merkley (D-OR) and the Sentinel Assurance for Effective Devices Act of 2012 introduced by Rep. Lois Capps (D-CA), there had been no action on the part of OMB to date to pass the legislation in the face of mounting congressional pressure.

Under language passed in both the FDA Reform Act in the House and the FDA Safety and Innovation Act (FDASIA) in the Senate, the FDA and OMB would be given a deadline before which it would need to pass the UDI rule. FDARA mandates FDA to promulgate regulations no later than 120 days after the enactment of FDARA. The Senate proposes a slower pace of adoption, saying proposed regulations would need to be in place by 31 December 2012, final regulations be in place by 31 June 2013 and the regulations in effect by 31 June 2015.

The Gray Sheet reported in April the FDA was looking to launch the UDI system by the start of January 2013 “regardless of the status of the UDI proposed rule,” but little information has emerged since then and it is unclear whether either FDARA or FDASIA would affect FDA’s proposed actions.

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