All classes of devices should have a UDI on the label or package in two years, and direct markings on the devices in three years, Premier contends. The recently enacted FDA Safety and Innovation Act clearly demonstrates congressional interest for quick UDI implementation, it adds. “UDI is the missing link to protect patient safety. Enabling health care providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting.”
Other recommendations in the comment letter, available here, include:
* Exclude providers from UDI label requirements for repackaging devices for internal use,
* Include products such as insulin syringes and glucometers sold in retail establishments, with the UPC code deemed as the UDI, and
* Change the proposed date format from Arabic numerals (Oct. 18, 2012) to the international distribution standard of yyyy-mm-dd.