|The US Medical Device Market is the world’s largest at an estimated US $127.1bn in 2013 and is very highly regulated. Clear and detailed information relating to devices must be submitted to the FDA for approval and clearances, to market these devices in the US. Rules and regulations are evolving and the introduction of the Unique Device Identification system stengthens this core area of compliance.The medical device industry has long awaited the introduction of the Unique Device Identification system. The UDI system along with clear and accurate guidance for industry regarding the Global Unique Device Identification Database will assist device labellers and the FDA in obtaining consistent and accurate data.
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