The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The UDI is a unique code made up of two parts. The UDI Rule gives criteria for labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the United States. UDI compliance dates have been set by the FDA according to device category.
In August 2014, Advanced Medical Technology Association (AdvaMed) explained to the FDA in a proposal the “unique complexities and challenges for conveying UDIs on the device or device label to the point of use” for certain products. AdvaMed gave possible solutions to maintain the correct identification of devices which become separated from their original label and package during cleaning and sterilization.
Following this proposal, the CDRH is allowing an extension of the compliance date for the UDI labeling requirements to September 24, 2016, for –
(1) Medical devices classified with primary product codes and with certain regulations.
(2) Medical devices that are single use implants.
(3) Medical devices intended to be sterilized before use.
The letter regarding the UDI extension also contains a list of extensions.
For the final UDI guidance click here.
For the AdvaMed proposal click here.
For the letter regarding UDI extension click here.