FDA guidance updates UDI compliance policy

Editor's Note

The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately.

The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes the guidance issued January 16, 2018, which outlined the FDA’s compliance policy for UDI label, date format, and direct mark requirement for Class I and unclassified devices.

Though in effect immediately, the guidance is available for comments and suggestions at any time for Agency consideration. Comments will not be acted upon until this document is next revised or updated.