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.
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