The Coalition supports efforts to streamline the supply chain procurement process while ensuring that low-cost, non-invasive medical healthcare products are treated fairly. We are dedicated to a safe, efficient and cost-effective medical products supply chain that will benefit patient care.
Specifically, the Coalition supports a Uniform Device Identification standard that reduces the cost of compliance, increases efficiency and improves patient safety.
On July 3 2012, the Food & Drug Administration (FDA) released a proposed rule setting rules and a time frame to implement a unique device identification system (UDI) for medical devices. The UDI requirements begin for Class III devices within a year of the final rule (spring of 2013) and ending with some requirements for Class I devices within five years of the final rule.
In 2007, Congress passed legislation that directed the FDA to develop regulations establishing a UDI system for medical devices. Government legislators and regulators envision a national product identification system that can improve both medical device tracking and safety surveillance. Standardized product identification systems began with Universal Product Code (UPC) barcodes in the 1970’s, and the use of identification systems is prevalent in the retail and food industries.
The UDI compliance requirements will be phased-in over a period of 7 years, unless otherwise exempted.
Convenience kits not already classified as I, II, or III are required to have a UDI by the applicable date below of the highest class of device in the kit (e.g., if the kit contains a Class II device the kit would have to meet the September 24, 2016 compliance date).
- September 24, 2014 – Class III medical device and/or a devices licensed under the Public Health Service Act
- September 24, 2015 – Any implantable, life supporting, of life sustaining device not designated by the FDA as Class III
- September 24, 2016 – Class II medical devices
- September 24, 2018 – Class I medical devices
- September 24, 2018 – Any other device not classified into Class I, II, or III
- 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 bear a 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
*Devices introduced into commerce within the last 3 years have a 3 year extension to the applicable deadline.