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FDA Issues Updated Guidance on Medical Device UDI Requirements

The U.S. Food and Drug Administration (FDA) has released an updated Guidance on the unique device identification (UDI) requirements for medical devices, easing its requirements for certain types of low-risk devices.

The updated Guidance states that the FDA will no longer enforce standard date formatting and UDI labeling requirements for certain unclassified medical devices under its Global Unique Device Identification Database (GUDID) policy. This exemption includes consumer health products, that is, “510(k)-exempt class 1 devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores.”

The updated Guidance does not exempt Class 1 devices from the GUDID policy requirements. However, it extends until December 8, 2022, the compliance deadline for certain types of Class 1 devices.

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In both cases, the updated Guidance states that newly exempt devices must still bear UDI data on their labeling and packaging.

Read the text of the FDA’s Guidance on Medical Device UDI Requirements.

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