The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the form and content of unique device identifier (UDI) labeling and information required for medical devices.
The FDA’s UDI requirements create a standardized identification system for medical devices and for stand-alone software that is regulated as a medical device. UDI systems make it possible to definitively identify a medical device quickly and to verify its key attributes to help ensure its safe and effective use.
The Guidance, “Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI),” is intended to provide medical device manufacturers with detailed information on the agency’s requirements regarding the form and content of UDIs, as required under FCC regulations. The Final Guidance updates the draft version of the Guidance originally issued in July 2016.
Guidances issued by the FDA and other federal agencies are intended solely to provide interested parties with information on the current views of the agency with regard to a specific issue and do not have the force of law.