FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Sets UDI Compliance Deadlines for Class I, Unclassified Devices

Jan. 18, 2018

The FDA issued “immediately in effect” guidance for manufacturers of class I and unclassified medical devices on compliance dates for meeting unique device identification requirements.

For the standard date formatting, labeling and Global Unique Device Identification Database (GUDID) data submission requirements, the newly established compliance date is Sept. 24, 2018. For UDI direct mark requirements, the compliance date is Sept. 24, 2020.

These differ from the agency’s enforcement dates, however. The agency does not intend to enforce UDI labeling, GUDID data submission or standard date format requirements for class I and unclassified devices manufactured or labeled on or after Sept. 24, 2018 until Sept. 24, 2020.

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