FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

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http://www.raps.org/Regulatory-Focus/News/2014/11/20/20803/FDA-Decides-to-Delay-UDI-Labeling-Rule-for-Some-Orthopedic-Implants/

FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants

Posted 20 November 2014By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) is granting labelers of certain types of implantable medical devices a temporary reprieve from its upcoming requirements that all medical device products be marked with a unique device identifier (UDI) meant to make the devices safer.

Background

A UDI is, as its name implies, a system of identifying each medical device using a specific system.

The system has a number of allures for regulators. "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 2012.

- See more at: http://www.raps.org/Regulatory-Focus/News/2014/11/20/20803/FDA-Decides-to-Delay-UDI-Labeling-Rule-for-Some-Orthopedic-Implants/#sthash.4x4e7QqL.dpuf