UDI Compliance Deadline Less Than a Year Away

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.
Dates on the labels of these devices must be formatted as required. Data for these devices must be submitted to the GUDID database.
A 1-year extension of this compliance date may be requested under; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required.

September 24, 2015
• The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.
Dates on the labels of these devices must be formatted as required.
• 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.
Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required.
• 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.

September 24, 2016
• 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.
• The labels and packages of class II medical devices must bear a UDI.
Dates on the labels of these devices must be formatted as required.
Class II stand-alone software must provide its UDI as required.
• Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.

September 24, 2018
• 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.
• 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.
Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required.
• 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.
Class I stand-alone software must provide its UDI as required.

September 24, 2020
• 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.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID database. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.