FDA’s Medical Device Tracking Proposal Remains Stalled at OMB
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 releaseÂ a proposed rule based onÂ FDA's plan.
Patient Advocates Criticize Delay
Patient advocates and some lawmakers have criticized OMB's delay in releasingÂ 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 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 (Norman, Politico, 2/6).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.