Regulatory Focus™ > News Articles > FDA Unveils Proposed Device Identification System, New Database

FDA Unveils Proposed Device Identification System, New Database

Posted 03 July 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) announced Tuesday, 3 July its intent to implement a long-delayed Unique Device Identifier (UDI) rule, which would mandate most medical devices carry an identifier capable of allowing the device to be traced back to its point of origin.

The UDI rule was mandated by the FDA Amendments Act (FDAAA) of 2007, but the rule has thus far failed to be implemented due to a confluence of factors including industry criticism and a stalled review at the Office of Management and Budget (OMB).

In announcing the proposed system, FDA said the numbers will conform to a standardized, alpha-numeric system of identifying elements, which will be contained within an FDA-run database.

"The unique device identification system will help reduce medical errors, and will allow FDA, the healthcare community, and industry to more rapidly review and assess adverse event reports, identify problems relating to a particular device, and thereby allow for more rapid and effective corrective actions that focus sharply on the specific devices that are of concern," FDA wrote in the proposed rule.

The proposed rule has not yet been published in the Federal Register, but FDA made a copy of it available on its website on 3 July 2012. The extensive, 164-page proposed rule describes the UDI system and how devices are to be marked.

Some notable excerpts include:

  • Devices intended to be used long-term and separated from its packaging will require the device itself to be labeled with a UDI, including implantable or multi-use medical devices and stand-alone software.
  • All UDI information will need to be submitted to FDA's proposed database of UDI information, known as the Global Unique Device Identification Database (GUDID).
  • "UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology."

Comments are due 120 days after the proposed rule's publication in the Federal Register.

Read more:

FDA - Unique Device Identification System

FDA - Explanation of Unique Device Identification

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