FDA has proposed the Unique Device Identification (UDI) rule in July 2012. The UDI requirement will be subsequently applied to all three types of medical devices. Type III Devices with the highest risk of safety will be required to adhere to the UDI rule for its basic label and packaging design within the first year of publication of UDI rule. Type II and Type I devices will be required to do so within five and seven years respectively.



Read more in FDA's official online publication.