Here are five key points:
1. Per the guidance, UDIs must come in one of two formats — plain-text version and an automated version. The FDA details guidelines for how providers should order UDI information.
2. Providers can add automated UDIs to a patient’s electronic health record or other computer system. Previously, guidelines did not require specific technology to develop the UDIs, and the UDIs did not need to be in a specific form. However, the recently issued guidelines mandate the automated version to be in a format a barcode scanner or comparable technology can read.
3. The guidelines permit automated markers to be broken into multiple segments if the package or device space is limited. If this is the case, the information regarding the specific model must precede the production information.
4. Per the guidance, Class III devices need to have UDIs on their packages as well as on the devices themselves.
5. The medical device system is in the third year of its seven-year roll-out and the FDA is accepting draft guidance comments for up to 60 days.
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