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The effect of the FDA’s UDI rule on the makers of medical devices

When designing medical devices and equipment, engineers have to be cognizant of a wide variety of rules and regulations. That’s why we want to make you aware of a soon-to-be-enforced rule from the Food and Drug Administration (FDA) that mandates a unique device identifier (UDI) on all medical devices. While the requirements are very specific, here are the highlights of the UDI rule:

  • The UDI must be provided in a plain text version and in a form that uses automatic identification and data capture technology such as a bar code or RFID.
  • The UDI is a set of alphanumeric codes consisting of a device identifier (company and product code) and a production identifier (specific manufacturing information).
  • All UDIs will be issued under a system operated by an FDA-accredited issuing agency.
  • To ensure a smooth implementation and to spread the costs and burdens of implementation over time, the UDI system will go into effect in stages – with compliance achieved by 2020.

More information about this rule can be found on the FDA’s website. Of course, you will also want to consult with your company’s legal team to ensure compliance.

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