January 16, 2018
FDA delays UDI compliance dates for class I, unclassified devices
Editor's Note
The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022.
The guidance does not apply to implantable, life-supporting or life-sustaining devices. Labelers of these devices must already be in compliance with UDI requirements.
The table below outlines key compliance dates established by FDA in conjunction with the UDI final rule. Compliance Dates Established by FDA in Conjunction with UDI Final Rule 1 year after publication of the final rule (September 24, 2014) The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
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