February 8, 2012

FDA’s Medical Device Tracking Plan Remains Stalled at OMB

Editor’s Note:  The article fails to explain the role of OMB review of regulations in providing oversight of the Executive Branch’s regulatory program, a review power exercised in eight consecutive Administrations.

From: iHealthBeat

An FDA proposal to create a medical device identification system has been stalled since it was sent to the Office of Management and Budget for review in July 2011, prompting criticisms of inaction from patient advocates, Politico reports.


There is no uniform labeling system for medical devices, making it difficult to track down problematic equipment used by hospitals and patients.

In 2007, Congress voted to support FDA’s plan to create an identification system for the devices.

In July 2011, FDA sent its proposal to OMB for review, but OMB has yet to release a proposed rule based on FDA’s plan.

Patient Advocates Criticize Delay

Patient advocates and some lawmakers have criticized OMB’s delay in releasing the proposed rule.

Sen. Herb Kohl (D-Wis.) said, “For every day that we wait on putting [unique device identifiers] in place, a significant number of patients are placed at risk.”

Jeff Secunda — vice president for technology and regulatory affairs at AdvaMed — said other countries will become frustrated waiting on the U.S. to advance UDIs and likely will install incompatible systems on their own.

OMB’s Response

OMB has not explained the reason for the delay.

However, a representative from the agency said it is not uncommon for reviews of far-reaching regulations to be extended.

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