UDI is fast approaching. Suppliers of medical devices have to understand the production implications of the 2016 deadline and should identify the ideal direct marking solution for their products. With FOBA's infographic you get more information about UDI, deadlines and requirements.

UDI is a unique device identification system created and regulated by the Food and Drug Administration (FDA). It is designed to adequately identify medical devices through their distribution and use. When fully implemented, most medical devices will include a unique device identifier in human and machine-readable forms. When required, these identifiers must not only appear on labels and packaging, but on the devices themselves as in the case of repeatedly used equipment (i.e. surgical tools, instruments) which has to be marked directly.

The summary of FOBA is for informational purposes only and is not intended as legal advice. For a complete description of the Unique Device Identification system, go to: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/

Please contact FOBA for more information, sample marking and application consulting.

Check it out to stay on track with deadlines and requirements!