In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed, requiring the FDA to institute a unique device identification (UDI) provision. Its intention was to increase patient safety by improving the flow of information on medical devices.
In 2015, the FDA required medical device labelers to register UDIs for implantable, life-supporting, and life-sustaining medical devices – a crucial step towards increasing traceability, transparency, and accuracy across the healthcare supply chain. This was also part of a larger initiative to provide global visibility and ensure that all medical devices contain a UDI by 2020.
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