On September 24th 2013, FDA has released a system to improve the quality and the safety of medical devices. The Unique Device Identification (UDI) consists of a unique numeric or alphanumeric code that includes two parts: a device identifier and a production identifier. As a part of the UDI system, FDA establishes a Global Unique Device Identification Database (GUDID). A compliance agenda is available and based on to the medical devices classification.
Implementing this new regulation can be challenging but help is available, do not hesitate to contact us for more information.