FDA UDI Class I and Unclassified Policy Guidance

The U.S. Food and Drug Administration released the immediately-in-effect (IIE) guidance document, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The guidance lists and explains several key elements of FDA’s enforcement discretion policy, including the Agency’s intention to not enforce standard date formatting, labeling, and GUDID data submission requirements for class I and unclassified devices before September 24, 2020; to not enforce direct mark requirements for class I and unclassified devices before September 24, 2022; and to not enforce standard date formatting, labeling, and GUDID data submission requirements until September 24, 2021, and direct mark requirements until September 24, 2022 for finished devices manufactured and labeled prior to September 24, 2018. The full guidance is at the link provided.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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