May 01, 2014 Industry news
In September 2013 the US Food and Drug Administration (FDA) published its final ruling for Unique Device Identification (UDI) compliance for medical devices in the US.
Compliance Date Requirements
Below is a summary of the compliance dates for meeting the FDA UDI requirements:
- 24/09/2014 - The labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.
- 24/09/2015 - The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.
- 24/09/2016 A Class III device required to be labelled 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.
- 24/09/2018 - A Class II device that is required to be labelled 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.
- 24/09/2020 - A Class I device, and devices that have not been classified into Class I, Class II, or Class III that are required to be labelled with a UDI, must a bear a UDI as a permanentmarking on the device itself if this is a device intended to be used more than once and intended to be reprocessed before each use.
GS1 standards meet all the requirements of the UDI, such as:
- Product identification at each level of the packaging hierarchy
- The bar code symbols to use
- The product data to be included in bar codes
- The data that must be stored within the Global UDI Database specified by the US FDA
You can find out more about the resources we have available to help support healthcare businesses reach UDI compliance here.
GS1 UK will be presenting at the upcoming Association of British Healthcare Industries (ABHI) seminar – UDI Systems: the Here and Now of Implementation – which is designed to provide UK companies with unique insights into the UDI implementation requirements.
The seminar will be hosted by Jay Crowley, who until recently led the FDA development of the UDI regulation.