FDA

FDA Issues Final Guidance on UDI Compliance Policy and Extends Enforcement Deadline

By MedTech Intelligence Staff
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FDA

The FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022.

On July 22, the FDA posted its final guidance regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products.

The guidance document, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices,” was updated to clarify that FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices considered to be consumer health products that are required to bear a UDI on their labels and device packages. Additionally, the FDA does not intend to enforce the GUDID submission requirements for Class I and unclassified devices, other than implantable, life-supporting or life-sustaining devices, regardless of whether they are consumer health products, before December 8, 2022. This new date provides a 75-day extension of the previously published guidance document.

 

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