FDA issues final guidance on UDI direct marking requirements: 4 things to know

The FDA published a final guidance Nov. 17 on unique device identifier marking requirements.

Here are four things to know.

1. The agency first released a draft guidance on UDI direct marking — which requires devicemakers to mark any device intended to be reprocessed with an etching or tag indicating the products' expected lifetime — in June 2015.

2. The finalized marking requirements apply to all devices intended "to undergo high-level disinfection and/or sterilization before or between each use," according to a blog post from Registrar Corp. The draft guidance clarifies the requirements do not apply to implants.

3. The agency will not enforce UDI labeling and direct marking compliance for any devices loaned to a health system before the marking requirements take effect.

4. The FDA will enforce direct marking requirements for class I medical devices starting Sept. 24, 2022. Enforcement of class II devices will take effect Sept. 24, 2018.

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