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U.S. Department of Health and Human Services

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Summary: Regulatory Impact Analysis of Unique Device Identification System Final Rule

This final rule establishes a unique device identification system to implement § 519(f) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).  The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception from some or all of the requirements of the final rule.  The UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture technology.  Device labelers must submit information concerning each device labeled with a UDI to FDA’s Global Unique Device Identification Database (GUDID).  The UDI is 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.  Medical device records throughout the required device recordkeeping and reporting systems will have to include the UDI.  In addition, the final rule establishes accreditation requirements for organizations that issue UDIs and establishes the conditions for when FDA might act as an issuing agency.  Depending on the risk of the device, labelers will have from 1 to 7 years to comply with the UDI system.

Regulatory Impact Analysis

Federal Register: 78 FR 58785, September 24, 2013

Docket: FDA-2011-N-0090