The FDA has been implementing the unique device identification system in waves. When the implementation process is complete, devices will be labeled with a unique device identifier (UDI) readable to both humans and machines. September 24, 2018 marks the date for a series of compliance requirements including:

  • UDI compliance for direct marking of class II devices
  • UDI required for most kits with at least one class III, I/LS/LS or class II device within the kit
  • UDI required for most co-packaged and cross-labeled combination products with a device constituent
  • The expiration of the 801.3(a)(1) (three year “grandfather”) I/LS/LS inventory exception
  • UDI compliance for class I/unclassified devices for labeling and GUDID submission

Complying to these measures will be more difficult for some health systems than others. Some EHR and tracking systems are not prepared to incorporate UDI data. Furthermore, the requirement for providers to upload data to the FDA’s global UDI database may be costly in terms of labor.

If your health system is on the track to meet some of these requirements on time, but not others, don’t fret. The FDA has issued a guidance manual and has indicated that they do not intend to enforce compliance for two years (9/24/2020). The FDA also provides resources through an online Help Desk.

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