The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
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