FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)

In July 2012, the FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical devices (Unique Device Identification System, UDI system). Also the Global Harmonization Task Force (GHTF) addressed the topic last year (see our GMP News from 02 November 2011). The Congress had already enacted a law in 2007 for the FDA to develop such a system. A draft is now available.

The FDA expects from this UDI system to improve the quality of information regarding medical devices and adverse events. It is hoped to faster identify product problems and targeted recalls. Thanks to improved identification medical errors of the medical devices by the medical staff should be reduced. Eventually, medical devices "counterfeits" should become more recognizable. All these measures should lead to improved patients safety. The number should help identifying a specified medical device and its manufacturer.

In this context, the FDA would like to create a database and make it available to the public. This database shall provide a standard set of essential identification features for each UDI. The medical device's user should then find easily information about his / her medical device. Comments to the draft can be sent until 7 November 2012. This draft can be found on the internet.
Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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