Here are the Compliance Dates for the FDA UDI Ruling

Compliance Dates for UDI Requirements

The table below outlines key compliance dates in the UDI final rule.

Summary of Compliance Dates for the UDI Final Rule

Compliance Date	Requirement
1 year after publication of the final rule	The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.  § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18.   Data for these devices must be submitted to the GUDID database.  § 830.300.
2 years after publication of the final rule	The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.  § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18.
	A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.  § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
	Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
3 years after publication of the final rule	Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
	The labels and packages of class II medical devices must bear a UDI.  § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b).
	Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300.
5 years after publication of the final rule	A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
	The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI.  § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
	Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database.  § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b).
7 years after publication of the final rule	Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.  § 801.45.
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.