
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.