Regulatory Focus™ > News Articles > Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

Proposed FDA Rules for UDIs, Laser Products Continue to Languish at OMB

Posted 03 April 2012 | By Alexander Gaffney, RAC 

Two rules continue to languish at the US Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA), according to records.

The Unique Device Identification (UDI) rule, which was mandated under the FDA Amendments Act of 2007, would establish a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier.

The economically significant rule has been held up at OIRA since 11 July 2011, with no clear end in sight. The measure has since been taken up by Senator Jeff Merkley, who introduced the Ensuring Safe Medical Devices for Patients Act that would, among other things, require "FDA to issue a final UDI rule by the end of 2012."

Lesser-noticed but more-delayed is a rule dealing with medical products that use lasers. FDA proposed a rule which would "achieve closer harmonization between the current standard and the International Electrotechnical Commission (IEC) standard for laser products and medical laser products."

"The proposal would adopt portions of an IEC standard to achieve greater harmonization and reflect current science," wrote OIRA in its abstract of the proposed rule.

FDA submitted the proposed rule, Laser Products; Amendment to Performance Standard, to OIRA on 24 May 2011, where it, too, has lingered without final approval from OMB since.

Read more:

OIRA - Unique Device Identification 

OIRA - Laser Products; Amendment to Performance Standard 

Regulatory Focus - Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB

Regulatory Focus - Bill Would Address Medical Device Safety By Giving FDA Additional Authority

Regulatory Focus - Hoping to Relax Regulatory Burdens, Medical Device Manufacturers Gain Clout on the Hill

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