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Today, the U.S. Food and Drug Administration (FDA) posted the final guidance, 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. The FDA updated this final guidance to include the FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain Class I devices considered consumer health products. The update to this guidance reflects the finalization of the draft guidance "Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices", which was issued October 14, 2021, and following the consideration of public comments. This final guidance describes the FDA's compliance policy regarding GUDID submission requirements for certain Class I devices considered consumer health products. 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 an existing FDA compliance policy published in the July 2020 version of this guidance. Questions? If you have questions about this final guidance, contact the FDA UDI Help Desk. | | | |
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