UDI References

History

UDI refers to a government initiative, a Unique Device Identifier system for medical devices. On September 27, 2007, the Food and Drug Administration (FDA) Amendments Act of 2007 was signed into law.

On July 10, 2012, the U.S. Food and Drug Administration (FDA) issued a proposed rule implementing a 2007 statutory requirement to establish a unique device identification system for medical devices. The rule would phase in over seven years a requirement that many device labels and packages include a unique device identifier (UDI) based on international standards (such as GS1 data standards).

The FDA completed a pilot test of a prototype UDI Database (UDID). The purpose of the pilot was to better understand the data attributes and assess the feasibility and usability of the UDID. They were especially interested in manufacturer's ability to identify and organize the data and load it into the database as well as user’s ability to use, retrieve, and export the information.

On September 20, 2013, the FDA announced the final ruling on UDI Regulation and Guidance. The announcement was made at 8:45 am EST, at the 5th Annual FDA-UDI conference in Baltimore, Maryland.

Summary: The FDA is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.

The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

The identification system established under this rule will lead to more accurate reporting of adverse events by making it easier to identify the device prior to submitting a report. It will allow FDA, healthcare providers, and industry to more rapidly extract useful information from adverse event reports, pinpoint the particular device at issue and thereby gain a better understanding of the underlying problems, and take appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to conform to a standard format to ensure those dates are unambiguous and clearly understood by device users.

Legislative/Government Correspondence:

Legislative Correspondence:

Letter to Sen. Jeff Merkley from the Advancing Patient Safety Coalition (of which AHRMM is a member) expressing strong support for the Ensuring Safe Medical Devices for Patients bill.

Government Correspondence:

AHRMM and Four Other Leading Healthcare Organizations Request Immediate Release of the FDA's Proposed Rule on Unique Device Identifiers (UDIs) — RIN: 0910-AG31

AHRMM's correspondence to the FDA on the subject of Unique Device Identifiers

Advancing Patient Safety Coalition's (APSC) correspondence to the FDA