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

On 1 July 2020 the FDA issued the immediately in effect guidance for industry and FDA staff.

This guidance describes FDA’s intention regarding enforcement of these requirements for class I and unclassified devices.

This guidance also describes FDA’s direct marking compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct marking compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.

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