Draft Guidance: Select Updates to Global UDI Database

Read about the Class I devices for which the FDA does not intend to enforce submission requirements and how to identify them.

If your email program has trouble displaying this email, view as a webpage. FDA Issues New Draft Guidance on Global Unique Device Identification Database (GUDID) Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. Read the draft guidance Facts about the draft guidance The FDA developed this draft guidance to revise "Section III. Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices" of the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking, ("2020 UDI Compliance Policy Guidance") that was issued on July 1, 2020. The draft guidance explains there are certain class I devices that are considered consumer health products for which the FDA does not intend to enforce GUDID submission requirements under 21 CFR 830.300. The draft guidance also describes how a labeler of a class I device can determine if their device is within the scope of this compliance policy. Note: This guidance is not for implementation at this time. Submit Comments on the Draft Guidance This draft guidance will be open for public comments for 60 days at https://www.regulations.gov under Docket Number FDA-2017-D-6841. Questions? If you have questions about this draft guidance, contact the UDI Help Desk at GUDIDSupport@fda.hhs.gov.

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