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FDA Issues Guidance Regarding Compliance Dates for Unique Device Identification Requirements

Today, the U.S. Food and Drug Administration (FDA) issued the immediately in effect guidance: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.

Read the Guidance The guidance explains several key elements of the FDA’s policy regarding Unique Device Identification compliance dates. Stakeholders should understand that the FDA: Does not intend to enforce Unique Device Identification labeling compliance for certain class I and unclassified devices that are not implantable, life-supporting, or life-sustaining before September 24, 2022. Has not altered other policies that were conveyed in a previous (November 2018) version of the guidance. Submit Comments This guidance will be open for public comments https://www.regulations.gov under Docket Number FDA-2017-D-6841. Questions? If you have any questions about this guidance document, contact the Division of Industry and Consumer Education (DICE).