Devices & Diagnostics, Hospitals, Policy

Amendment to proposed UDI guidance from FDA now requires quicker compliance

If the makers of high-risk, implantable medical devices were hoping that the U.S. Food and […]

If the makers of high-risk, implantable medical devices were hoping that the U.S. Food and Drug Administration would delay how soon they would have to implement labeling and directly marking physical devices under its unique device identifier scheme, their hopes were dashed.

The agency announced Wednesday that it was amending its proposed rule regarding the unique device identifier system by which makers of Class III implantable, life-supporting and life-sustaining devices “would have to bear a UDI as a permanent marking on the device itself one year earlier than proposed.”

For Class II implantable devices, the deadline is three years earlier and for Class I devices it is five years sooner than originally proposed.

These amendments are required based on the FDA Safety and Innovation Act signed in the summer. However, it looks like the agency did not heed trade group’s AdvaMed’s request to delay the UDI on the device label and packaging until two years after the final rule is issued. That provision remained unchanged at one year after final issuance.

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