The US Food and Drug Administration released an amendment seeking to speed the deadlines for establishing a unique device identification (UDI) system, or numeric or alphanumeric code on certain medical devices. Specifically, the amendment would apply to “implantable, life-supporting, and life-sustaining” devices. This would mean that devices in the Class III or high-risk category would require a UDI marking one year earlier than originally proposed. Implantable devices in Class II or moderate-risk category would need a UDI marking three years earlier than first proposed.
Implantable devices in Class I or considered low-risk will require a UDI marking five years earlier than originally proposed, with the label and device package requirement one year earlier than first proposed.
The new deadlines are needed to comply with the Food and Drug Administration Safety and Innovation Act, which was signed into law on July 9, 2012. The label must include the serial number and expiration date for the device.
The FDA is accepting public comments on the proposed change to the UDI timeline until Dec. 19.
