FDA UDI Timeline for Implementation

On September 24, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that established the need for the Unique Device Identification (UDI) System. Soon after the UDI System was signed into law as part of the Food and Drug Administration Amendments Act of 2007, the FDA was called to publish a timeline for the UDI implementation.

FDA timeline based on the risk class of the devices

• 1 year after issuance of final rule – Class III devices
• 2 years after issuance of final rule – Class II implants and life-supporting/life-sustaining devices
• 3 years after issuance of final rule – Remaining class II devices
• 5 years after issuance of final rule – Class I devices

September 24, 2014 – 1 Year after Issuance of Final Rule

• A unique device identifier (UDI) will be required on all class III medical devices.
• UDI data should be submitted to the Global Unique Device Identification Database (GUDID).
• A 1-year extension can be requested latest by June 23, 2014.
• UDI must be provided by class III stand-alone software

September 24, 2015 – 2 Years after Issuance of Final Rule

• UDI must be present on class II life-sustaining & supporting and implantable devices.
• For devices that are designed to be used more than once and/or require processing before every reuse, a permanent UDI marking on the devices themselves is required.
• UDI must be provided by class III stand-alone software that is life-sustaining or life-supporting

September 24, 2016 – 3 Years after Issuance of Final Rule

• A permanent UDI marking on the devices themselves is required in the case of Class III devices that are designed to be used more than once and/or require processing before every reuse.
• A UDI must be present on the packages and labels of class II medical devices. The UDI data should be submitted to the GUDID.
• UDI must be provided by class II stand-alone software

September 24, 2018 – 5 Years after Issuance of Final Rule

• A permanent UDI marking on the devices themselves is required in the case of Class II devices that are designed to be used more than once and/or require processing before every reuse.
• A UDI must be present on the packages and labels of class I medical devices.
• UDI must be provided by class I stand-alone software
• UDI must also be present on devices not yet classified into class I, class II, or class III. The UDI data should be submitted to the GUDID.

September 24, 2020 – 7 Years after Issuance of Final Rule

• A permanent UDI marking on the devices themselves is required in the case of devices that have not been classified into class I, class II, or class III and are designed to be used more than once and/or require processing before every reuse.

The implementation timeline is generally perceived as quite lengthy. Patients will have to wait until 2020 to benefit from a system with a completely operational device tracking system. Nonetheless, the final rule brings the U.S. one step closer to a UDI system that improves adverse event reporting, among other things. According to research, UDI’s implementation will also translate into around $16 billion in savings per annum. These remarkable cost savings will be primarily driven by automation of previously manual processes as well as enhanced efficiencies across the medical system.