Coverage

Labelling compliance – what you need to know

In September 2013, the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use.

The system, which is being phased in over several years, means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machine-readable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.

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