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FDA Issues Final Rule on Unique Device Identifiers

September 27, 2013—The Food and Drug Administration (FDA) Sept. 24 issued a final rule establishing a requirement that labels on most medical devices include a unique device identifier (UDI) that would allow for the tracking of devices and could facilitate device recalls.  The system will be implemented in stages, with a compliance deadline for manufacturers ranging from one to five years, depending on whether a device is classified as high-risk, moderate risk, or lower risk.  Some Class One (low risk) devices will be exempt from the new labeling requirements.

AAMC had earlier issued a letter thanking Sens. Jeff Merkley (D-Ore.), Michael Bennet (D-Colo.), Chuck Grassley (R-Iowa), and Herb Kohl (D-Wis.) for introducing the Ensuring Safe Medical Devices for Patients Act (S. 2193), which required the FDA to issue a final rule implementing the UDI system by the end of 2012 [see Washington Highlights, March 23, 2012].  The association also joined the Advancing Patient Safety Coalition in a June 4, 2013 letter urging the Office of Management and Budget (OMB) to release the proposed rule [see Washington Highlights, June 8, 2012].

The proposed rule was issued in the July 10, 2012 Federal Register, and AAMC joined the Advancing Patient Safety Coalition in a comment letter  addressing several issues in the proposed rule.  “We support the general UDI framework,” the Coalition stated. “On patient safety grounds, we urge the FDA to ensure that UDI requirements apply down to the normal unit of use for a patient so that a device can be properly identified as it is being used by or furnished to the patient.


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


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
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Telephone: 202-903-0806