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FDA Releases Proposed Rule Covering Implementation of Unique Device Identifier

July 2012

The Food and Drug Administration (FDA) recently released the long-awaited proposed rule for implementing the unique device identifier (UDI). The proposed UDI rule has been the subject of much frustration for industry and consumer advocates, given the extended review of the proposed rule required by the Office of Management and Budget (OMB) before it would allow the FDA to release it. The UDI, upon full implementation, will allow the FDA to track individual devices in the event of a recall or safety concern.

The proposed rule would require device packaging and labeling to include a UDI in plain-text and in a form that uses automatic identification and data capture (AIDC) technology. Certain categories of devices, such as implantables and those intended for reuse will also need to have the UDI imprinted upon them directly.

The FDA is expected to phase-in implementation of the UDI requirements. The FDA Safety and Innovation Act, anticipated to be signed into law by the President within the next week, requires the FDA to release a final rule within six months of the close of the notice and comment period and to implement the UDI for implantable, life-saving and life-sustaining devices within two years from the release of the final regulations. Public comments are due to the Agency within 120 days from the official date of publication (July 10) and can be submitted at www.regulations.gov.