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AAMC Urges Speedy Implementation of UDI System in FDA Bill

June 8, 2012—In a June 4 letter  to the conference committee charged with reconciling the House  and Senate versions of the Food and Drug Administration (FDA) reauthorization legislation (H.R. 5651, S. 3187), AAMC joined the Advancing Patient Safety Coalition in urging inclusion of a Senate provision that would require implementation of the unique device identification (UDI) system within two years of finalizing regulations. The letter continues AAMC support for implementation of a UDI system that would allow tracking of medical devices and thus enhance patient safety.

The coalition’s letter said, “We believe a UDI system is essential to help protect the safety of patients, reduce medical errors and strengthen the ability of the FDA and manufacturers to monitor adverse events. Every day that goes by without such electronic identification of medical devices is a threat to patient safety and increases costs in the healthcare system. UDI is the missing link to better ensuring patient safety. Implementing a national UDI system will not only reduce clinical risks to patients, but will also save an estimated $16 billion in costs annually which are incurred due to inefficiencies in the medical products supply chain.”

Currently, the proposed rule to implement the UDI system is delayed at the Office of Management and Budget (OMB), where it has been since July 2011. The AAMC has advocated previously for UDI implementation and supported Senate legislation that would expedite the implementation process [see Washington Highlights, March 23].

Both House  and Senate versions of the FDA reauthorization legislation include language requiring OMB to release the proposed regulation for implementation of the UDI system. However, the Senate-version goes further to require OMB to “finalize regulations within six months after the close of the comment period, and to implement a national UDI system within two years after the final regulation is issued.”


David E. Longnecker, M.D.
Director, Health Care Affairs
Telephone: 202-862-6113

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926


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Jason Kleinman
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Telephone: 202-903-0806